NuPathe A1C3AV FDA approval!!! Neubewertung? - 500 Beiträge pro Seite
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ISIN: US67059M1009 · WKN: A1C3AV
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| Wertpapier | Kurs | Perf. % |
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| 10,000 | +25,00 | |
| 6,0000 | +25,00 | |
| 0,7113 | +21,90 | |
| 0,6400 | +18,52 | |
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|---|---|---|
| 0,8410 | -17,06 | |
| 9,7200 | -19,60 | |
| 4,0000 | -27,27 | |
| 2,7280 | -29,14 | |
| 14,510 | -32,32 |
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Antwort auf Beitrag Nr.: 44.035.992 von fortuna924 am 18.01.13 09:18:26http://www.finanznachrichten.de/nachrichten-2013-01/25728091…
Antwort auf Beitrag Nr.: 44.035.997 von fortuna924 am 18.01.13 09:19:28mehrere 100% sind m.Meinung in den nächsten Wochen möglich 
http://seekingalpha.com/news-article/5337981-nupathe-s-zecui…
http://seekingalpha.com/news-article/5337981-nupathe-s-zecui…
Antwort auf Beitrag Nr.: 44.036.011 von fortuna924 am 18.01.13 09:21:29hier der Inhalt 
NuPathe's Zecuity Approved by the FDA for the Acute Treatment of Migraine
Thu January 17, 2013 6:17 PM | about: PATH
NEWS PROVIDED BY:
Marketwire
CONSHOHOCKEN, PA -- (Marketwire) -- 01/17/13 -- NuPathe Inc. (PATH) (NASDAQ: PATH) today announced that the U.S. Food and Drug Administration (FDA) has approved Zecuity" (sumatriptan iontophoretic transdermal system) for the acute treatment of migraine with or without aura in adults. Zecuity is a single-use, battery-powered patch that actively delivers sumatriptan, the most widely prescribed migraine medication, through the skin. Zecuity provides relief of both migraine headache pain and migraine-related nausea (MRN).
"The approval of Zecuity represents a major milestone for NuPathe and migraine sufferers," said Armando Anido , CEO of NuPathe. "As the first and only FDA-approved migraine patch, we believe Zecuity will be a game-changing treatment option for millions of migraine patients, especially those with migraine-related nausea. We thank the patients and physicians who participated in our clinical trials as well as our employees for their support throughout the development of Zecuity. We now intensify our focus to securing commercial partners and preparing for the launch of Zecuity expected in the fourth quarter of this year."
"In addition to severe headache pain, migraine patients present with other significant symptoms, which commonly includes migraine-related nausea," said Lawrence C. Newman, MD, FAHS, FAAN, Director of the Headache Institute at St. Luke's-Roosevelt Hospital in New York. "For these patients, physicians need to assess and offer treatments tailored to each individual patient's array of migraine symptoms. In fact, the American Academy of Neurology guidelines recommend a non-oral route of administration for migraineurs who experience nausea or vomiting as significant symptoms."
"Migraine-related nausea can be as debilitating as migraine headache pain itself," said study investigator Stephen D. Silberstein, MD, FACP, FAHS, FAAN, Professor of Neurology and Director of the Jefferson Headache Center in Philadelphia. "Treatments bypassing the GI tract may be the best way to treat these patients."
Zecuity was approved based upon an extensive development program with phase 3 trials that included 800 patients using more than 10,000 Zecuity patches. In these trials, Zecuity was proven safe and effective at treating migraine and relieving its cardinal symptoms (headache pain, migraine-related nausea and sensitivity to light and sound) two hours after patch activation.
In the phase 3 pivotal study, twice as many patients treated with Zecuity achieved freedom from headache pain at two hours compared with placebo (18% and 9%, respectively). Additionally, 53% of patients treated with Zecuity achieved relief from headache pain and 84% were nausea free at two hours (29% and 63%, respectively, with placebo). The incidence of triptan-associated adverse events known as "atypical sensations" and "pain and other pressure sensations" was 2% each in Zecuity-treated patients. The most common (greater than 5%) side effects of Zecuity were application site pain, tingling, itching, warmth and discomfort.
About Zecuity
ZECUITY" (sumatriptan iontophoretic transdermal system) is indicated for the acute treatment of migraine with or without aura in adults. Zecuity is a single-use, battery-powered patch applied to the upper arm or thigh during a migraine. Following application and with a press of a button, Zecuity initiates transdermal delivery (through the skin), bypassing the gastrointestinal tract. Throughout the four-hour dosing period, the microprocessor within Zecuity continuously monitors skin resistance and adjusts drug delivery accordingly to ensure delivery of 6.5 mg of sumatriptan, the most widely prescribed migraine medication, with minimal patient-to-patient variability.
Important Safety Information
Patients should not take ZECUITY if they have heart disease, a history of heart disease or stroke, peripheral vascular disease (narrowing of blood vessels to your legs, arms, stomach or kidney), transient ischemic attack (TIA) or problems with blood circulation, uncontrolled blood pressure, migraines that cause temporary paralysis on one side of the body or basilar migraine, Wolff-Parkinson-White syndrome or other disturbances of heart rhythm. Very rarely, certain people, even some without heart disease, have had serious heart-related problems after taking triptans like ZECUITY.
Patients should not use ZECUITY if they have taken other migraine medications such as ergotamine medications or other triptans in the last 24 hours or if they have taken monoamine oxidase-A (MAO-A) inhibitors within the last 2 weeks.
Patients should not use ZECUITY during magnetic resonance imaging (MRI).
Patients should not use ZECUITY if they have an allergy to sumatriptan or components of ZECUITY or if they have had allergic contact dermatitis (ACD) following use of ZECUITY. If patients develop ACD, they should talk to their healthcare provider before using sumatriptan in another form.
ZECUITY, like other triptans, may be associated with a potentially life-threatening condition called serotonin syndrome, mainly when used together with certain types of antidepressants including serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs).
Patients should tell their healthcare provider before using ZECUITY if they have heart disease or a family history of heart disease, stroke, high cholesterol or diabetes; have gone through menopause; are a smoker; have had epilepsy or seizures or if they are pregnant, nursing or thinking about becoming pregnant.
The most common side effects of ZECUITY are application site pain, tingling, itching, warmth and discomfort. Most patients experience some skin redness after removing ZECUITY. This redness typically goes away in 24 hours.
Please see full Prescribing Information for ZECUITY.
Patients are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.
Patients and healthcare providers interested in more information on Zecuity should visit www.zecuity.com.
Company to Host Investor Conference Call
NuPathe will host a conference call tomorrow, January 18, 2013, at 8:30 a.m. EST to discuss the FDA approval of Zecuity. A question and answer session will follow NuPathe's remarks. To participate on the live call, please dial 888-329-8862 (domestic) or +1-719-325-2420 (international), and provide the participant passcode 9170164 five to ten minutes before the start of the call. A live audio webcast of the call will be available via the Investor Relations page of the NuPathe website, www.nupathe.com. Please log on through NuPathe's website approximately 10 minutes prior to the scheduled start time.
A replay of the webcast will also be archived on the Company's website for 90 days following the call. A replay of the call will be available for 90 days within a few hours after the call ends. Investors may listen to the replay of the call by dialing 888-203-1112 (domestic) or +1-719-457-0820 (international), with the passcode 9170164.
About Migraine and Migraine-Related Nausea (MRN)
Migraine is a debilitating neurological disease afflicting a large underserved patient population. Migraine is characterized by headache pain accompanied by associated neurological and GI symptoms including nausea, vomiting, photophobia, and phonophobia.(1,2) In the U.S., 31 million adults, with approximately three times as many women as men,(3) suffer from migraine.(3,4,5) Of the 16 million migraine patients who are diagnosed and treated, approximately eight million experience migraine-related nausea (MRN) in at least half of their migraine attacks.(6) These frequent-MRN patients report significantly more migraine symptom burden and experience significantly more interference with work, social and family life.(6) Many migraine patients who experience MRN delay or avoid taking orally administered medications due to nausea or vomiting.(7)
About NuPathe
NuPathe Inc. is a specialty pharmaceutical company focused on innovative neuroscience solutions for diseases of the central nervous system including neurological and psychiatric disorders. NuPathe's lead product, Zecuity (sumatriptan iontophoretic transdermal system), has been approved by the FDA for the acute treatment of migraine with or without aura in adults. Zecuity is expected to be available by prescription in the fourth quarter of 2013. In addition to Zecuity, NuPathe has two proprietary product candidates based on its LAD", or Long-Acting Delivery, biodegradable implant technology that allows delivery of therapeutic levels of medication over a period of months with a single dose. NP201, for the continuous symptomatic treatment of Parkinson's disease, utilizes a leading FDA-approved dopamine agonist, ropinirole, and is being developed to provide up to two months of continuous delivery. NP202, for the long-term treatment of schizophrenia and bipolar disorder, is being developed to address the long-standing problem of patient noncompliance by providing three months of continuous delivery of risperidone, an atypical antipsychotic. NuPathe is actively seeking partnerships to maximize the commercial potential for Zecuity and its other product candidates in the U.S. and territories throughout the world.
For more information about NuPathe, please visit our website and our blog at www.nupathe.com. You can also follow us on StockTwits (stocktwits.nupathe.com), Twitter (twitter.nupathe.com), SlideShare (slideshare.nupathe.com) and LinkedIn (linkedin.nupathe.com).
Cautionary Note Regarding Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. All statements that are not historical facts are hereby identified as forward-looking statements for this purpose and include, among others, statements relating to: the potential benefits of, and commercial opportunity for, Zecuity and NuPathe's other product candidates; partnering plans for Zecuity and NuPathe's other product candidates; the timing of the expected launch and availability of Zecuity; and other statements relating to NuPathe's plans, objectives, expectations and beliefs regarding its future operations, performance, financial condition and other future events. Forward-looking statements are based upon management's current expectations and beliefs and are subject to a number of risks, uncertainties, assumptions and other factors that could cause actual results and events to differ materially from those indicated herein including, among others: NuPathe's ability to obtain sufficient capital to launch Zecuity; NuPathe's ability to obtain commercial and development partners for Zecuity and its other product candidates; NuPathe's reliance on third parties to manufacture Zecuity; NuPathe's ability to establish and effectively manage its supply chain; NuPathe's ability to establish effective marketing and sales capabilities; market acceptance among physicians and patients and the availability of adequate reimbursement from third party payors for Zecuity; and the risks, uncertainties and other factors discussed in NuPathe's Annual Report on Form 10-K for the year ended December 31, 2010 and Quarterly Report on Form on Form 10-Q for the quarter ended September 30, 2012 under the caption "Risk Factors" and elsewhere in such reports, which are available on NuPathe's website at www.nupathe.com in the "Investor Relations -- SEC Filings" section. While NuPathe may update certain forward-looking statements from time to time, it specifically disclaims any obligation to do so, whether as a result of new information, future developments or otherwise. You are cautioned not to place undue reliance on any forward-looking statements.
References
1. ICHD-II. Cephalagia 2004; 24 (Suppl 1).
2. Lipton, R. et al. Classification of primary headaches. Neurology. 2004:63:427-435.
3. Lipton, R. et al. Prevalence and Burden of Migraine in the United States: Data From the American Migraine Study II. Headache, July/August 2001: p. 646.
4. US Census Data. 1999, accessed at http://www.census.gov/prod/2001pubs/p23-205.pdf 01/03/13; and 2010, accessed at http://www.census.gov/2010census/data/.
5. NuPathe Analysis.
6. Lipton, R. et al. "Frequency and Burden of Headache-Related Nausea: Results from the American Migraine Prevalence and Prevention (AMPP) Study." Headache 2012:53:93-103. Funded by a research grant from NuPathe Inc.
7. Silberstein, S. Migraine symptoms: results of a survey of self-reported migraineurs. Headache 1995;35:387-396.
Contact Information:
INVESTOR CONTACTS
Westwicke Associates
John Woolford
(443) 213-0506
john.woolford@westwicke.com
MEDIA CONTACTS:
6 Degrees
Tony Plohoros
(908) 940-0135
tplohoros@6degreespr.com
Sage Strategic Marketing
Jennifer Guinan
(610) 410-8111
jennifer@sagestrat.com
Source: NuPathe Inc.
NuPathe's Zecuity Approved by the FDA for the Acute Treatment of Migraine
Thu January 17, 2013 6:17 PM | about: PATH
NEWS PROVIDED BY:
Marketwire
CONSHOHOCKEN, PA -- (Marketwire) -- 01/17/13 -- NuPathe Inc. (PATH) (NASDAQ: PATH) today announced that the U.S. Food and Drug Administration (FDA) has approved Zecuity" (sumatriptan iontophoretic transdermal system) for the acute treatment of migraine with or without aura in adults. Zecuity is a single-use, battery-powered patch that actively delivers sumatriptan, the most widely prescribed migraine medication, through the skin. Zecuity provides relief of both migraine headache pain and migraine-related nausea (MRN).
"The approval of Zecuity represents a major milestone for NuPathe and migraine sufferers," said Armando Anido , CEO of NuPathe. "As the first and only FDA-approved migraine patch, we believe Zecuity will be a game-changing treatment option for millions of migraine patients, especially those with migraine-related nausea. We thank the patients and physicians who participated in our clinical trials as well as our employees for their support throughout the development of Zecuity. We now intensify our focus to securing commercial partners and preparing for the launch of Zecuity expected in the fourth quarter of this year."
"In addition to severe headache pain, migraine patients present with other significant symptoms, which commonly includes migraine-related nausea," said Lawrence C. Newman, MD, FAHS, FAAN, Director of the Headache Institute at St. Luke's-Roosevelt Hospital in New York. "For these patients, physicians need to assess and offer treatments tailored to each individual patient's array of migraine symptoms. In fact, the American Academy of Neurology guidelines recommend a non-oral route of administration for migraineurs who experience nausea or vomiting as significant symptoms."
"Migraine-related nausea can be as debilitating as migraine headache pain itself," said study investigator Stephen D. Silberstein, MD, FACP, FAHS, FAAN, Professor of Neurology and Director of the Jefferson Headache Center in Philadelphia. "Treatments bypassing the GI tract may be the best way to treat these patients."
Zecuity was approved based upon an extensive development program with phase 3 trials that included 800 patients using more than 10,000 Zecuity patches. In these trials, Zecuity was proven safe and effective at treating migraine and relieving its cardinal symptoms (headache pain, migraine-related nausea and sensitivity to light and sound) two hours after patch activation.
In the phase 3 pivotal study, twice as many patients treated with Zecuity achieved freedom from headache pain at two hours compared with placebo (18% and 9%, respectively). Additionally, 53% of patients treated with Zecuity achieved relief from headache pain and 84% were nausea free at two hours (29% and 63%, respectively, with placebo). The incidence of triptan-associated adverse events known as "atypical sensations" and "pain and other pressure sensations" was 2% each in Zecuity-treated patients. The most common (greater than 5%) side effects of Zecuity were application site pain, tingling, itching, warmth and discomfort.
About Zecuity
ZECUITY" (sumatriptan iontophoretic transdermal system) is indicated for the acute treatment of migraine with or without aura in adults. Zecuity is a single-use, battery-powered patch applied to the upper arm or thigh during a migraine. Following application and with a press of a button, Zecuity initiates transdermal delivery (through the skin), bypassing the gastrointestinal tract. Throughout the four-hour dosing period, the microprocessor within Zecuity continuously monitors skin resistance and adjusts drug delivery accordingly to ensure delivery of 6.5 mg of sumatriptan, the most widely prescribed migraine medication, with minimal patient-to-patient variability.
Important Safety Information
Patients should not take ZECUITY if they have heart disease, a history of heart disease or stroke, peripheral vascular disease (narrowing of blood vessels to your legs, arms, stomach or kidney), transient ischemic attack (TIA) or problems with blood circulation, uncontrolled blood pressure, migraines that cause temporary paralysis on one side of the body or basilar migraine, Wolff-Parkinson-White syndrome or other disturbances of heart rhythm. Very rarely, certain people, even some without heart disease, have had serious heart-related problems after taking triptans like ZECUITY.
Patients should not use ZECUITY if they have taken other migraine medications such as ergotamine medications or other triptans in the last 24 hours or if they have taken monoamine oxidase-A (MAO-A) inhibitors within the last 2 weeks.
Patients should not use ZECUITY during magnetic resonance imaging (MRI).
Patients should not use ZECUITY if they have an allergy to sumatriptan or components of ZECUITY or if they have had allergic contact dermatitis (ACD) following use of ZECUITY. If patients develop ACD, they should talk to their healthcare provider before using sumatriptan in another form.
ZECUITY, like other triptans, may be associated with a potentially life-threatening condition called serotonin syndrome, mainly when used together with certain types of antidepressants including serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs).
Patients should tell their healthcare provider before using ZECUITY if they have heart disease or a family history of heart disease, stroke, high cholesterol or diabetes; have gone through menopause; are a smoker; have had epilepsy or seizures or if they are pregnant, nursing or thinking about becoming pregnant.
The most common side effects of ZECUITY are application site pain, tingling, itching, warmth and discomfort. Most patients experience some skin redness after removing ZECUITY. This redness typically goes away in 24 hours.
Please see full Prescribing Information for ZECUITY.
Patients are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.
Patients and healthcare providers interested in more information on Zecuity should visit www.zecuity.com.
Company to Host Investor Conference Call
NuPathe will host a conference call tomorrow, January 18, 2013, at 8:30 a.m. EST to discuss the FDA approval of Zecuity. A question and answer session will follow NuPathe's remarks. To participate on the live call, please dial 888-329-8862 (domestic) or +1-719-325-2420 (international), and provide the participant passcode 9170164 five to ten minutes before the start of the call. A live audio webcast of the call will be available via the Investor Relations page of the NuPathe website, www.nupathe.com. Please log on through NuPathe's website approximately 10 minutes prior to the scheduled start time.
A replay of the webcast will also be archived on the Company's website for 90 days following the call. A replay of the call will be available for 90 days within a few hours after the call ends. Investors may listen to the replay of the call by dialing 888-203-1112 (domestic) or +1-719-457-0820 (international), with the passcode 9170164.
About Migraine and Migraine-Related Nausea (MRN)
Migraine is a debilitating neurological disease afflicting a large underserved patient population. Migraine is characterized by headache pain accompanied by associated neurological and GI symptoms including nausea, vomiting, photophobia, and phonophobia.(1,2) In the U.S., 31 million adults, with approximately three times as many women as men,(3) suffer from migraine.(3,4,5) Of the 16 million migraine patients who are diagnosed and treated, approximately eight million experience migraine-related nausea (MRN) in at least half of their migraine attacks.(6) These frequent-MRN patients report significantly more migraine symptom burden and experience significantly more interference with work, social and family life.(6) Many migraine patients who experience MRN delay or avoid taking orally administered medications due to nausea or vomiting.(7)
About NuPathe
NuPathe Inc. is a specialty pharmaceutical company focused on innovative neuroscience solutions for diseases of the central nervous system including neurological and psychiatric disorders. NuPathe's lead product, Zecuity (sumatriptan iontophoretic transdermal system), has been approved by the FDA for the acute treatment of migraine with or without aura in adults. Zecuity is expected to be available by prescription in the fourth quarter of 2013. In addition to Zecuity, NuPathe has two proprietary product candidates based on its LAD", or Long-Acting Delivery, biodegradable implant technology that allows delivery of therapeutic levels of medication over a period of months with a single dose. NP201, for the continuous symptomatic treatment of Parkinson's disease, utilizes a leading FDA-approved dopamine agonist, ropinirole, and is being developed to provide up to two months of continuous delivery. NP202, for the long-term treatment of schizophrenia and bipolar disorder, is being developed to address the long-standing problem of patient noncompliance by providing three months of continuous delivery of risperidone, an atypical antipsychotic. NuPathe is actively seeking partnerships to maximize the commercial potential for Zecuity and its other product candidates in the U.S. and territories throughout the world.
For more information about NuPathe, please visit our website and our blog at www.nupathe.com. You can also follow us on StockTwits (stocktwits.nupathe.com), Twitter (twitter.nupathe.com), SlideShare (slideshare.nupathe.com) and LinkedIn (linkedin.nupathe.com).
Cautionary Note Regarding Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. All statements that are not historical facts are hereby identified as forward-looking statements for this purpose and include, among others, statements relating to: the potential benefits of, and commercial opportunity for, Zecuity and NuPathe's other product candidates; partnering plans for Zecuity and NuPathe's other product candidates; the timing of the expected launch and availability of Zecuity; and other statements relating to NuPathe's plans, objectives, expectations and beliefs regarding its future operations, performance, financial condition and other future events. Forward-looking statements are based upon management's current expectations and beliefs and are subject to a number of risks, uncertainties, assumptions and other factors that could cause actual results and events to differ materially from those indicated herein including, among others: NuPathe's ability to obtain sufficient capital to launch Zecuity; NuPathe's ability to obtain commercial and development partners for Zecuity and its other product candidates; NuPathe's reliance on third parties to manufacture Zecuity; NuPathe's ability to establish and effectively manage its supply chain; NuPathe's ability to establish effective marketing and sales capabilities; market acceptance among physicians and patients and the availability of adequate reimbursement from third party payors for Zecuity; and the risks, uncertainties and other factors discussed in NuPathe's Annual Report on Form 10-K for the year ended December 31, 2010 and Quarterly Report on Form on Form 10-Q for the quarter ended September 30, 2012 under the caption "Risk Factors" and elsewhere in such reports, which are available on NuPathe's website at www.nupathe.com in the "Investor Relations -- SEC Filings" section. While NuPathe may update certain forward-looking statements from time to time, it specifically disclaims any obligation to do so, whether as a result of new information, future developments or otherwise. You are cautioned not to place undue reliance on any forward-looking statements.
References
1. ICHD-II. Cephalagia 2004; 24 (Suppl 1).
2. Lipton, R. et al. Classification of primary headaches. Neurology. 2004:63:427-435.
3. Lipton, R. et al. Prevalence and Burden of Migraine in the United States: Data From the American Migraine Study II. Headache, July/August 2001: p. 646.
4. US Census Data. 1999, accessed at http://www.census.gov/prod/2001pubs/p23-205.pdf 01/03/13; and 2010, accessed at http://www.census.gov/2010census/data/.
5. NuPathe Analysis.
6. Lipton, R. et al. "Frequency and Burden of Headache-Related Nausea: Results from the American Migraine Prevalence and Prevention (AMPP) Study." Headache 2012:53:93-103. Funded by a research grant from NuPathe Inc.
7. Silberstein, S. Migraine symptoms: results of a survey of self-reported migraineurs. Headache 1995;35:387-396.
Contact Information:
INVESTOR CONTACTS
Westwicke Associates
John Woolford
(443) 213-0506
john.woolford@westwicke.com
MEDIA CONTACTS:
6 Degrees
Tony Plohoros
(908) 940-0135
tplohoros@6degreespr.com
Sage Strategic Marketing
Jennifer Guinan
(610) 410-8111
jennifer@sagestrat.com
Source: NuPathe Inc.
Antwort auf Beitrag Nr.: 44.036.012 von fortuna924 am 18.01.13 09:22:19NB war der Kurs schon bei 4,31$ 
Trading Spotlight
Antwort auf Beitrag Nr.: 44.036.021 von fortuna924 am 18.01.13 09:23:37Wieviele Menschen auf der Welt haben Migräne???
Antwort auf Beitrag Nr.: 44.036.026 von fortuna924 am 18.01.13 09:24:33NuPathe will host a conference call tomorrow, January 18, 2013, at 8:30 a.m. EST to discuss the FDA approval of Zecuity. A question and answer session will follow NuPathe's remarks. To participate on the live call, please dial 888-329-8862 (domestic) or +1-719-325-2420 (international), and provide the participant passcode 9170164 five to ten minutes before the start of the call. A live audio webcast of the call will be available via the Investor Relations page of the NuPathe website, www.nupathe.com. Please log on through NuPathe's website approximately 10 minutes prior to the scheduled start time.
A replay of the webcast will also be archived on the Company's website for 90 days following the call. A replay of the call will be available for 90 days within a few hours after the call ends. Investors may listen to the replay of the call by dialing 888-203-1112 (domestic) or +1-719-457-0820 (international), with the passcode 9170164.
A replay of the webcast will also be archived on the Company's website for 90 days following the call. A replay of the call will be available for 90 days within a few hours after the call ends. Investors may listen to the replay of the call by dialing 888-203-1112 (domestic) or +1-719-457-0820 (international), with the passcode 9170164.
Antwort auf Beitrag Nr.: 44.036.026 von fortuna924 am 18.01.13 09:24:33die amis konnten doch schon drauf reagieren.17.1
Antwort auf Beitrag Nr.: 44.036.072 von ultrawuffsn am 18.01.13 09:32:54ja sicher.
Die Meldung kam NB.
Es gab ein Tradinghalt. Wer hat da noch die Möglichkeit einzusteigen???
Schau dir Arena an. Dann siehst Du was auch hier möglich ist
Die Meldung kam NB.
Es gab ein Tradinghalt. Wer hat da noch die Möglichkeit einzusteigen???
Schau dir Arena an. Dann siehst Du was auch hier möglich ist
Moin, jepp da werde ich auch mal mit reiten....
Arena Gesamtshares : Aktienanzahl 217,29 Mio.
NuPathe Gesamtshares : Aktienanzahl 14,75 Mio.
Nun ist die Frage was gestern so an Shorts gecovert wurde.....
Denke nicht so viel dh. das dürfte noch ordentlich abgehen hier...
Aber Arena und NUpathe....kannst du nicht 1 zu 1 vergleichen...
Arena Gesamtshares : Aktienanzahl 217,29 Mio.
NuPathe Gesamtshares : Aktienanzahl 14,75 Mio.
Nun ist die Frage was gestern so an Shorts gecovert wurde.....
Denke nicht so viel dh. das dürfte noch ordentlich abgehen hier...
Aber Arena und NUpathe....kannst du nicht 1 zu 1 vergleichen...
Antwort auf Beitrag Nr.: 44.035.992 von fortuna924 am 18.01.13 09:18:26Die Wirkung des Medikamentes unterscheidet sich aber nicht gravierend von den Placebos, die man bei der Studie ebenfalls eingesetzt hat. (53% zu 29%).
Wenn ich einen Schädel habe, dann ist es egal, ob ich eine Aspirin oder Cola+Chips zu mir nehme. Beide wirken gleich gut/schlecht.
Auf die News konnten die Amis schon gestern reagieren, daher wird entscheidend sein, wieviele Trader drauf einspringen und ob die Aktie ein Momentum entwickeln kann.
Die Pille gegen Migräne ist in meinen Augen aber keine dolle Sache.
Trotzdem, viel Glück allen.
Wenn ich einen Schädel habe, dann ist es egal, ob ich eine Aspirin oder Cola+Chips zu mir nehme. Beide wirken gleich gut/schlecht.
Auf die News konnten die Amis schon gestern reagieren, daher wird entscheidend sein, wieviele Trader drauf einspringen und ob die Aktie ein Momentum entwickeln kann.
Die Pille gegen Migräne ist in meinen Augen aber keine dolle Sache.
Trotzdem, viel Glück allen.
im Premarket schon ein Kauf.....geht scheinbar früh los heute....
http://www.nasdaq.com/symbol/path/premarket#.UPkSoGdDCEI
http://www.nasdaq.com/symbol/path/premarket#.UPkSoGdDCEI
Antwort auf Beitrag Nr.: 44.036.165 von Earthfire am 18.01.13 09:50:40wolte Arena auch nicht mit Nupath vergleichen. Nur auf das Potential hinweisen
Antwort auf Beitrag Nr.: 44.036.247 von Laprog am 18.01.13 10:08:18hattest du schon einmal Migräne?
Dann ist es einem auch egal, was man wie einnimmt, Hauptsache die Schmerzen werden gelindert.
Dann ist es einem auch egal, was man wie einnimmt, Hauptsache die Schmerzen werden gelindert.
Antwort auf Beitrag Nr.: 44.036.331 von fortuna924 am 18.01.13 10:25:53VB zumindest schon einmal bei 4,39$
Antwort auf Beitrag Nr.: 44.036.346 von fortuna924 am 18.01.13 10:28:24VB 4,67$ bei kleinen Umsätzen
Bin dabei! Wird lustig werden - die Amis rechnen mittelfristig mit bis zu $14 bei 10% Anteil am Markt...
Between $7 to $9 Company Value:
"NuPathe has a great shot at seeing a triple in its stock price, if the FDA approves Zecuity in January 2013. With a current market cap of under $50M along with the large size of the migraine market, if NuPathe was able to grab 10% of the US market share ( a rather small percentage), its revenue could easily exceed $170M. Based on this potential, its market cap could easily see a speculative price of $500M moving forward. Obviously, with new financing the company's market cap would be based on 29.5 M sharesinstead of the current figure of 14.74M
Therefore NuPathe's top spec value would be around $14 a share.My estimate considers a "best case scenario" and it's not likely that if Zecuity gains approval, the stock price would actually be $14 -- more like $8.50 to $9.50 in my opinion."*
*from seeking alpha article.
"NuPathe has a great shot at seeing a triple in its stock price, if the FDA approves Zecuity in January 2013. With a current market cap of under $50M along with the large size of the migraine market, if NuPathe was able to grab 10% of the US market share ( a rather small percentage), its revenue could easily exceed $170M. Based on this potential, its market cap could easily see a speculative price of $500M moving forward. Obviously, with new financing the company's market cap would be based on 29.5 M sharesinstead of the current figure of 14.74M
Therefore NuPathe's top spec value would be around $14 a share.My estimate considers a "best case scenario" and it's not likely that if Zecuity gains approval, the stock price would actually be $14 -- more like $8.50 to $9.50 in my opinion."*
*from seeking alpha article.
Antwort auf Beitrag Nr.: 44.036.484 von Paul_Muadib am 18.01.13 10:56:40http://www.nasdaq.com/symbol/path/short-interest#.UPkcyKyS-q…
Antwort auf Beitrag Nr.: 44.036.490 von fortuna924 am 18.01.13 10:57:52Was meinste wohl, warum auf dem Yahoo-Board die Rede davon ist, dass PATH fallen wird...
Antwort auf Beitrag Nr.: 44.036.490 von fortuna924 am 18.01.13 10:57:52http://www.shortanalytics.com/getshortchart.php?tsymbol=path
Can this patch be used for these conditions ?
Re: Heart Medication, Diet, Diabetes
by istudyfish48 . 21 minutes ago . Permalink
Presumably, it could be used for many medications that aren't tolerated well when taken orally (cause nausea or vomiting) or with patients who have a needle phobia. Maybe that question will come up during the conference call at 8:30. Or, maybe someone else on the MB knows more about that. If it can potentially be used for other meds, the fact that it's patented makes this company worth a lot more than $6 to big pharma. It'll be fun to see what happens.
Sentiment: Strong Buy
Re: Heart Medication, Diet, Diabetes
by istudyfish48 . 21 minutes ago . Permalink
Presumably, it could be used for many medications that aren't tolerated well when taken orally (cause nausea or vomiting) or with patients who have a needle phobia. Maybe that question will come up during the conference call at 8:30. Or, maybe someone else on the MB knows more about that. If it can potentially be used for other meds, the fact that it's patented makes this company worth a lot more than $6 to big pharma. It'll be fun to see what happens.
Sentiment: Strong Buy
Antwort auf Beitrag Nr.: 44.036.517 von Paul_Muadib am 18.01.13 11:03:40dann bleib doch an der Seitenlinie 
Schau von wo der Kurs kommt und da wird er m.Meinung nach auch wieder hingehen.
Börse ist Zukunft. Und die ist hier gegeben.
Schau von wo der Kurs kommt und da wird er m.Meinung nach auch wieder hingehen.
Börse ist Zukunft. Und die ist hier gegeben.
Antwort auf Beitrag Nr.: 44.036.582 von Paul_Muadib am 18.01.13 11:19:21ok sorry, dann habe ich dich falsch verstanden.
Antwort auf Beitrag Nr.: 44.036.490 von fortuna924 am 18.01.13 10:57:52aus IHUB:
http://investorshub.advfn.com/boards/read_msg.aspx?message_i…
NuPathe’s transformative SmartRelief technology positions the company to capitalize on the
rapidly expanding global transdermal market (forecasted to increase from $21.5 to $31.5 billion by
2015), by potentially opening entirely new classes of medications for delivery through the skin.
"Here are some rough estimates from NuPathe's own presentation.
Annual gross revenue per patient using 2 patches/month average price of $90/patch
$80/patch = $1,900
$90/patch = $2,160
$100/patch = $2,400
lets say NuPathe captures 10% of the 12.5 million estimated patient opportunities. That is 1.25 million x median price $2,160/year = $2.7 Billion/year in sales.
NuPathe has 14,748,582 outstanding shares which translates to $183 revenue per share. That is CRAZY.
http://investorshub.advfn.com/boards/read_msg.aspx?message_i…
NuPathe’s transformative SmartRelief technology positions the company to capitalize on the
rapidly expanding global transdermal market (forecasted to increase from $21.5 to $31.5 billion by
2015), by potentially opening entirely new classes of medications for delivery through the skin.
"Here are some rough estimates from NuPathe's own presentation.
Annual gross revenue per patient using 2 patches/month average price of $90/patch
$80/patch = $1,900
$90/patch = $2,160
$100/patch = $2,400
lets say NuPathe captures 10% of the 12.5 million estimated patient opportunities. That is 1.25 million x median price $2,160/year = $2.7 Billion/year in sales.
NuPathe has 14,748,582 outstanding shares which translates to $183 revenue per share. That is CRAZY.
Antwort auf Beitrag Nr.: 44.036.791 von fortuna924 am 18.01.13 11:56:43Kursziel Tausend
Zitat von Laprog: Die Wirkung des Medikamentes unterscheidet sich aber nicht gravierend von den Placebos, die man bei der Studie ebenfalls eingesetzt hat. (53% zu 29%).
Wenn ich einen Schädel habe, dann ist es egal, ob ich eine Aspirin oder Cola+Chips zu mir nehme. Beide wirken gleich gut/schlecht.
Auf die News konnten die Amis schon gestern reagieren, daher wird entscheidend sein, wieviele Trader drauf einspringen und ob die Aktie ein Momentum entwickeln kann.
Die Pille gegen Migräne ist in meinen Augen aber keine dolle Sache.
Trotzdem, viel Glück allen.
Also meine Patienten fahren gut mit Sumatriptan, aber nicht alle. Mir ist nicht klar, worin der Vorteil einer transdermalen Applikation liegen soll, schon gar nicht, wenn die so teuer wird.
Ich will kein Spielverderber sein. Den aktuellen Kurssprung sollte man gern einsacken (wenn man dabei war-ich leider nicht) Einsteigen würde ich nicht mehr
Antwort auf Beitrag Nr.: 44.036.813 von fortuna924 am 18.01.13 12:00:35Bei der Shares....NuPathe Gesamtshares : Aktienanzahl 14,75 Mio.
würde es mich nicht wundern, wenn die Intraday einmal komplett durchgereicht würden...
würde es mich nicht wundern, wenn die Intraday einmal komplett durchgereicht würden...
Antwort auf Beitrag Nr.: 44.036.897 von Earthfire am 18.01.13 12:18:59abwarten was der CEO gleich zu sagen hat ...
Bin auch mal dabei zu 2,95 Euro. Hoffentlich war ich nicht zu voreilig.
Vom Pre-Market-High liegen wir ja jetzt 90 Cent entfernt.
läuft doch gut bis jetzt........
Orderbuch :
http://datasvr.tradearca.com/arcadataserver/ArcaBookData.php…
Orderbuch :
http://datasvr.tradearca.com/arcadataserver/ArcaBookData.php…
Ich beschwer mich ja auch nicht. Derzeit wieder 4 $.
Antwort auf Beitrag Nr.: 44.037.398 von fortuna924 am 18.01.13 13:56:28Wann spricht er denn?
Antwort auf Beitrag Nr.: 44.037.480 von Earthfire am 18.01.13 14:11:59Danke, also in gut 15 Minuten.
keine Kursfeststellung mehr in Frankfurt, bei Tradegate scheint es auch zu haken.
Har jemand einen link wo die Amis so über den Wert diskutieren? Danke.
CFO "60-70% margins on premium pricing" HIGHER THAN I THOUGHT
aus dem CC entnommen
aus dem CC entnommen
Nun kann die Rakete starten!
Sie zündet noch nicht richtig
Erste buy-ratings mit target $10 sind raus!
Ich glaube die wollen auf jeden Fall die 3,50$ sehen. Ich war heute auch etwas voreilig drinne. Heute Abend kann aber alles anders enden und wir sind locker über 4$
Punktlandung!
Gapclose bei 3,31$
Gapclose bei 3,31$
Antwort auf Beitrag Nr.: 44.038.058 von think-positive am 18.01.13 16:07:44das war wohl nix hier.
werde weiterhin mal beobachten.bis bald vielleicht.
werde weiterhin mal beobachten.bis bald vielleicht.
Antwort auf Beitrag Nr.: 44.040.466 von ultrawuffsn am 19.01.13 11:45:19Gap wurde geschlossen. Ab jetzt kann es weiter aufwärts gehen.
Jetzt noch eine Nachricht dass Merck Interesse hat ... .
Abearten....
Jetzt noch eine Nachricht dass Merck Interesse hat ... .
Abearten....
Antwort auf Beitrag Nr.: 44.041.589 von fortuna924 am 19.01.13 23:52:55Meinte natürlich "abwarten"
Ich habe mir vom Kursverlauf auch mehr versprochen.
Mal sehen was die Zukunft bringt
Ich habe mir vom Kursverlauf auch mehr versprochen.
Mal sehen was die Zukunft bringt
Antwort auf Beitrag Nr.: 44.041.589 von fortuna924 am 19.01.13 23:52:55so ne news und dann tagestief geschlossen.das gefällt mir erst mal gar nicht.kein grund also hier überhastet zu kaufen.risiko nach unten aber relativ begrenzt wenn man den chart anschaut.mal sehn.
Antwort auf Beitrag Nr.: 44.041.606 von ultrawuffsn am 20.01.13 00:11:58kann auch sein die drucken aktien um das ganze zu finanzieren.erst mal abwarten was hier wird.montag ist ja erst mal zu in amiland.
Antwort auf Beitrag Nr.: 44.041.606 von ultrawuffsn am 20.01.13 00:11:58ich hoffe das Tief haben wir jetzt erst einmal gesehen.
Mal schauen wie es die nächsten Tage weitergehen wird.
FDA approval erreicht. Fehlt nur noch ein grosser Partner an der Seite
von Nupathe. Der kann jederzeit bekanntgegeben werden.
Mal schauen wie es die nächsten Tage weitergehen wird.
FDA approval erreicht. Fehlt nur noch ein grosser Partner an der Seite
von Nupathe. Der kann jederzeit bekanntgegeben werden.
Antwort auf Beitrag Nr.: 44.043.093 von fortuna924 am 20.01.13 23:08:18Da heute die US Börsen geschlossen bleiben ist heute nachkaufen angesagt.
Antwort auf Beitrag Nr.: 44.043.342 von fortuna924 am 21.01.13 07:52:46fehlt nur noch der Partner
http://www.fool.com/investing/general/2013/01/18/nupathe-zec…
http://www.fool.com/investing/general/2013/01/18/nupathe-zec…
Antwort auf Beitrag Nr.: 44.043.370 von fortuna924 am 21.01.13 08:12:50ich rechne mit einem buyout in den nächsten Tagen/Wochen... .
Antwort auf Beitrag Nr.: 44.043.397 von fortuna924 am 21.01.13 08:28:47hier die News von der Homepage
http://nupathe.mwnewsroom.com/press-releases/nupathe-s-zecui…
http://nupathe.mwnewsroom.com/press-releases/nupathe-s-zecui…
Antwort auf Beitrag Nr.: 44.043.713 von fortuna924 am 21.01.13 09:58:54NuPathe's Zecuity Approved by the FDA for the Acute Treatment of Migraine
First FDA-Approved Migraine Patch
Conference Call Scheduled January 18 at 8:30 a.m. EST
CONSHOHOCKEN, PA--(Marketwire - Jan 17, 2013) - NuPathe Inc. (NASDAQ: PATH) today announced that the U.S. Food and Drug Administration (FDA) has approved Zecuity™ (sumatriptan iontophoretic transdermal system) for the acute treatment of migraine with or without aura in adults. Zecuity is a single-use, battery-powered patch that actively delivers sumatriptan, the most widely prescribed migraine medication, through the skin. Zecuity provides relief of both migraine headache pain and migraine-related nausea (MRN).
"The approval of Zecuity represents a major milestone for NuPathe and migraine sufferers," said Armando Anido, CEO of NuPathe. "As the first and only FDA-approved migraine patch, we believe Zecuity will be a game-changing treatment option for millions of migraine patients, especially those with migraine-related nausea. We thank the patients and physicians who participated in our clinical trials as well as our employees for their support throughout the development of Zecuity. We now intensify our focus to securing commercial partners and preparing for the launch of Zecuity expected in the fourth quarter of this year."
"In addition to severe headache pain, migraine patients present with other significant symptoms, which commonly includes migraine-related nausea," said Lawrence C. Newman, MD, FAHS, FAAN, Director of the Headache Institute at St. Luke's-Roosevelt Hospital in New York. "For these patients, physicians need to assess and offer treatments tailored to each individual patient's array of migraine symptoms. In fact, the American Academy of Neurology guidelines recommend a non-oral route of administration for migraineurs who experience nausea or vomiting as significant symptoms."
"Migraine-related nausea can be as debilitating as migraine headache pain itself," said study investigator Stephen D. Silberstein, MD, FACP, FAHS, FAAN, Professor of Neurology and Director of the Jefferson Headache Center in Philadelphia. "Treatments bypassing the GI tract may be the best way to treat these patients."
Zecuity was approved based upon an extensive development program with phase 3 trials that included 800 patients using more than 10,000 Zecuity patches. In these trials, Zecuity was proven safe and effective at treating migraine and relieving its cardinal symptoms (headache pain, migraine-related nausea and sensitivity to light and sound) two hours after patch activation.
In the phase 3 pivotal study, twice as many patients treated with Zecuity achieved freedom from headache pain at two hours compared with placebo (18% and 9%, respectively). Additionally, 53% of patients treated with Zecuity achieved relief from headache pain and 84% were nausea free at two hours (29% and 63%, respectively, with placebo). The incidence of triptan-associated adverse events known as "atypical sensations" and "pain and other pressure sensations" was 2% each in Zecuity-treated patients. The most common (greater than 5%) side effects of Zecuity were application site pain, tingling, itching, warmth and discomfort.
About Zecuity
ZECUITY™ (sumatriptan iontophoretic transdermal system) is indicated for the acute treatment of migraine with or without aura in adults. Zecuity is a single-use, battery-powered patch applied to the upper arm or thigh during a migraine. Following application and with a press of a button, Zecuity initiates transdermal delivery (through the skin), bypassing the gastrointestinal tract. Throughout the four-hour dosing period, the microprocessor within Zecuity continuously monitors skin resistance and adjusts drug delivery accordingly to ensure delivery of 6.5 mg of sumatriptan, the most widely prescribed migraine medication, with minimal patient-to-patient variability.
Important Safety Information
Patients should not take ZECUITY if they have heart disease, a history of heart disease or stroke, peripheral vascular disease (narrowing of blood vessels to your legs, arms, stomach or kidney), transient ischemic attack (TIA) or problems with blood circulation, uncontrolled blood pressure, migraines that cause temporary paralysis on one side of the body or basilar migraine, Wolff-Parkinson-White syndrome or other disturbances of heart rhythm. Very rarely, certain people, even some without heart disease, have had serious heart-related problems after taking triptans like ZECUITY.
Patients should not use ZECUITY if they have taken other migraine medications such as ergotamine medications or other triptans in the last 24 hours or if they have taken monoamine oxidase-A (MAO-A) inhibitors within the last 2 weeks.
Patients should not use ZECUITY during magnetic resonance imaging (MRI).
Patients should not use ZECUITY if they have an allergy to sumatriptan or components of ZECUITY or if they have had allergic contact dermatitis (ACD) following use of ZECUITY. If patients develop ACD, they should talk to their healthcare provider before using sumatriptan in another form.
ZECUITY, like other triptans, may be associated with a potentially life-threatening condition called serotonin syndrome, mainly when used together with certain types of antidepressants including serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs).
Patients should tell their healthcare provider before using ZECUITY if they have heart disease or a family history of heart disease, stroke, high cholesterol or diabetes; have gone through menopause; are a smoker; have had epilepsy or seizures or if they are pregnant, nursing or thinking about becoming pregnant.
The most common side effects of ZECUITY are application site pain, tingling, itching, warmth and discomfort. Most patients experience some skin redness after removing ZECUITY. This redness typically goes away in 24 hours.
Please see full Prescribing Information for ZECUITY.
Patients are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.
Patients and healthcare providers interested in more information on Zecuity should visit www.zecuity.com.
Company to Host Investor Conference Call
NuPathe will host a conference call tomorrow, January 18, 2013, at 8:30 a.m. EST to discuss the FDA approval of Zecuity. A question and answer session will follow NuPathe's remarks. To participate on the live call, please dial 888-329-8862 (domestic) or +1-719-325-2420 (international), and provide the participant passcode 9170164 five to ten minutes before the start of the call. A live audio webcast of the call will be available via the Investor Relations page of the NuPathe website, www.nupathe.com. Please log on through NuPathe's website approximately 10 minutes prior to the scheduled start time.
A replay of the webcast will also be archived on the Company's website for 90 days following the call. A replay of the call will be available for 90 days within a few hours after the call ends. Investors may listen to the replay of the call by dialing 888-203-1112 (domestic) or +1-719-457-0820 (international), with the passcode 9170164.
About Migraine and Migraine-Related Nausea (MRN)
Migraine is a debilitating neurological disease afflicting a large underserved patient population. Migraine is characterized by headache pain accompanied by associated neurological and GI symptoms including nausea, vomiting, photophobia, and phonophobia.1,2 In the U.S., 31 million adults, with approximately three times as many women as men,3 suffer from migraine.3,4,5 Of the 16 million migraine patients who are diagnosed and treated, approximately eight million experience migraine-related nausea (MRN) in at least half of their migraine attacks.6 These frequent-MRN patients report significantly more migraine symptom burden and experience significantly more interference with work, social and family life.6 Many migraine patients who experience MRN delay or avoid taking orally administered medications due to nausea or vomiting.7
About NuPathe
NuPathe Inc. is a specialty pharmaceutical company focused on innovative neuroscience solutions for diseases of the central nervous system including neurological and psychiatric disorders. NuPathe's lead product, Zecuity (sumatriptan iontophoretic transdermal system), has been approved by the FDA for the acute treatment of migraine with or without aura in adults. Zecuity is expected to be available by prescription in the fourth quarter of 2013. In addition to Zecuity, NuPathe has two proprietary product candidates based on its LAD™, or Long-Acting Delivery, biodegradable implant technology that allows delivery of therapeutic levels of medication over a period of months with a single dose. NP201, for the continuous symptomatic treatment of Parkinson's disease, utilizes a leading FDA-approved dopamine agonist, ropinirole, and is being developed to provide up to two months of continuous delivery. NP202, for the long-term treatment of schizophrenia and bipolar disorder, is being developed to address the long-standing problem of patient noncompliance by providing three months of continuous delivery of risperidone, an atypical antipsychotic. NuPathe is actively seeking partnerships to maximize the commercial potential for Zecuity and its other product candidates in the U.S. and territories throughout the world.
For more information about NuPathe, please visit our website and our blog at www.nupathe.com. You can also follow us on StockTwits (stocktwits.nupathe.com), Twitter (twitter.nupathe.com), SlideShare (slideshare.nupathe.com) and LinkedIn (linkedin.nupathe.com).
Cautionary Note Regarding Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. All statements that are not historical facts are hereby identified as forward-looking statements for this purpose and include, among others, statements relating to: the potential benefits of, and commercial opportunity for, Zecuity and NuPathe's other product candidates; partnering plans for Zecuity and NuPathe's other product candidates; the timing of the expected launch and availability of Zecuity; and other statements relating to NuPathe's plans, objectives, expectations and beliefs regarding its future operations, performance, financial condition and other future events. Forward-looking statements are based upon management's current expectations and beliefs and are subject to a number of risks, uncertainties, assumptions and other factors that could cause actual results and events to differ materially from those indicated herein including, among others: NuPathe's ability to obtain sufficient capital to launch Zecuity; NuPathe's ability to obtain commercial and development partners for Zecuity and its other product candidates; NuPathe's reliance on third parties to manufacture Zecuity; NuPathe's ability to establish and effectively manage its supply chain; NuPathe's ability to establish effective marketing and sales capabilities; market acceptance among physicians and patients and the availability of adequate reimbursement from third party payors for Zecuity; and the risks, uncertainties and other factors discussed in NuPathe's Annual Report on Form 10-K for the year ended December 31, 2010 and Quarterly Report on Form on Form 10-Q for the quarter ended September 30, 2012 under the caption "Risk Factors" and elsewhere in such reports, which are available on NuPathe's website at www.nupathe.com in the "Investor Relations -- SEC Filings" section. While NuPathe may update certain forward-looking statements from time to time, it specifically disclaims any obligation to do so, whether as a result of new information, future developments or otherwise. You are cautioned not to place undue reliance on any forward-looking statements.
References
1. ICHD-II. Cephalagia 2004; 24 (Suppl 1).
2. Lipton, R. et al. Classification of primary headaches. Neurology. 2004:63:427-435.
3. Lipton, R. et al. Prevalence and Burden of Migraine in the United States: Data From the American Migraine Study II. Headache, July/August 2001: p. 646.
4. US Census Data. 1999, accessed at http://www.census.gov/prod/2001pubs/p23-205.pdf 01/03/13; and 2010, accessed at http://www.census.gov/2010census/data/.
5. NuPathe Analysis.
6. Lipton, R. et al. "Frequency and Burden of Headache-Related Nausea: Results from the American Migraine Prevalence and Prevention (AMPP) Study." Headache 2012:53:93-103. Funded by a research grant from NuPathe Inc.
7. Silberstein, S. Migraine symptoms: results of a survey of self-reported migraineurs. Headache 1995;35:387-396.
Contact Information:
INVESTOR CONTACTS
Westwicke Associates
John Woolford
(443) 213-0506
john.woolford@westwicke.com
MEDIA CONTACTS:
6 Degrees
Tony Plohoros
(908) 940-0135
tplohoros@6degreespr.com
Sage Strategic Marketing
Jennifer Guinan
(610) 410-8111
jennifer@sagestrat.com
related links
CEO Q&A
Driving Shareholder Value
Publications & Presentations
Contacts
Investors
Westwicke Partners, LLC
443.213.0506
John Woolford
Media
Sage Strategic Marketing
610.410.8111
Jennifer Guinan
First FDA-Approved Migraine Patch
Conference Call Scheduled January 18 at 8:30 a.m. EST
CONSHOHOCKEN, PA--(Marketwire - Jan 17, 2013) - NuPathe Inc. (NASDAQ: PATH) today announced that the U.S. Food and Drug Administration (FDA) has approved Zecuity™ (sumatriptan iontophoretic transdermal system) for the acute treatment of migraine with or without aura in adults. Zecuity is a single-use, battery-powered patch that actively delivers sumatriptan, the most widely prescribed migraine medication, through the skin. Zecuity provides relief of both migraine headache pain and migraine-related nausea (MRN).
"The approval of Zecuity represents a major milestone for NuPathe and migraine sufferers," said Armando Anido, CEO of NuPathe. "As the first and only FDA-approved migraine patch, we believe Zecuity will be a game-changing treatment option for millions of migraine patients, especially those with migraine-related nausea. We thank the patients and physicians who participated in our clinical trials as well as our employees for their support throughout the development of Zecuity. We now intensify our focus to securing commercial partners and preparing for the launch of Zecuity expected in the fourth quarter of this year."
"In addition to severe headache pain, migraine patients present with other significant symptoms, which commonly includes migraine-related nausea," said Lawrence C. Newman, MD, FAHS, FAAN, Director of the Headache Institute at St. Luke's-Roosevelt Hospital in New York. "For these patients, physicians need to assess and offer treatments tailored to each individual patient's array of migraine symptoms. In fact, the American Academy of Neurology guidelines recommend a non-oral route of administration for migraineurs who experience nausea or vomiting as significant symptoms."
"Migraine-related nausea can be as debilitating as migraine headache pain itself," said study investigator Stephen D. Silberstein, MD, FACP, FAHS, FAAN, Professor of Neurology and Director of the Jefferson Headache Center in Philadelphia. "Treatments bypassing the GI tract may be the best way to treat these patients."
Zecuity was approved based upon an extensive development program with phase 3 trials that included 800 patients using more than 10,000 Zecuity patches. In these trials, Zecuity was proven safe and effective at treating migraine and relieving its cardinal symptoms (headache pain, migraine-related nausea and sensitivity to light and sound) two hours after patch activation.
In the phase 3 pivotal study, twice as many patients treated with Zecuity achieved freedom from headache pain at two hours compared with placebo (18% and 9%, respectively). Additionally, 53% of patients treated with Zecuity achieved relief from headache pain and 84% were nausea free at two hours (29% and 63%, respectively, with placebo). The incidence of triptan-associated adverse events known as "atypical sensations" and "pain and other pressure sensations" was 2% each in Zecuity-treated patients. The most common (greater than 5%) side effects of Zecuity were application site pain, tingling, itching, warmth and discomfort.
About Zecuity
ZECUITY™ (sumatriptan iontophoretic transdermal system) is indicated for the acute treatment of migraine with or without aura in adults. Zecuity is a single-use, battery-powered patch applied to the upper arm or thigh during a migraine. Following application and with a press of a button, Zecuity initiates transdermal delivery (through the skin), bypassing the gastrointestinal tract. Throughout the four-hour dosing period, the microprocessor within Zecuity continuously monitors skin resistance and adjusts drug delivery accordingly to ensure delivery of 6.5 mg of sumatriptan, the most widely prescribed migraine medication, with minimal patient-to-patient variability.
Important Safety Information
Patients should not take ZECUITY if they have heart disease, a history of heart disease or stroke, peripheral vascular disease (narrowing of blood vessels to your legs, arms, stomach or kidney), transient ischemic attack (TIA) or problems with blood circulation, uncontrolled blood pressure, migraines that cause temporary paralysis on one side of the body or basilar migraine, Wolff-Parkinson-White syndrome or other disturbances of heart rhythm. Very rarely, certain people, even some without heart disease, have had serious heart-related problems after taking triptans like ZECUITY.
Patients should not use ZECUITY if they have taken other migraine medications such as ergotamine medications or other triptans in the last 24 hours or if they have taken monoamine oxidase-A (MAO-A) inhibitors within the last 2 weeks.
Patients should not use ZECUITY during magnetic resonance imaging (MRI).
Patients should not use ZECUITY if they have an allergy to sumatriptan or components of ZECUITY or if they have had allergic contact dermatitis (ACD) following use of ZECUITY. If patients develop ACD, they should talk to their healthcare provider before using sumatriptan in another form.
ZECUITY, like other triptans, may be associated with a potentially life-threatening condition called serotonin syndrome, mainly when used together with certain types of antidepressants including serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs).
Patients should tell their healthcare provider before using ZECUITY if they have heart disease or a family history of heart disease, stroke, high cholesterol or diabetes; have gone through menopause; are a smoker; have had epilepsy or seizures or if they are pregnant, nursing or thinking about becoming pregnant.
The most common side effects of ZECUITY are application site pain, tingling, itching, warmth and discomfort. Most patients experience some skin redness after removing ZECUITY. This redness typically goes away in 24 hours.
Please see full Prescribing Information for ZECUITY.
Patients are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.
Patients and healthcare providers interested in more information on Zecuity should visit www.zecuity.com.
Company to Host Investor Conference Call
NuPathe will host a conference call tomorrow, January 18, 2013, at 8:30 a.m. EST to discuss the FDA approval of Zecuity. A question and answer session will follow NuPathe's remarks. To participate on the live call, please dial 888-329-8862 (domestic) or +1-719-325-2420 (international), and provide the participant passcode 9170164 five to ten minutes before the start of the call. A live audio webcast of the call will be available via the Investor Relations page of the NuPathe website, www.nupathe.com. Please log on through NuPathe's website approximately 10 minutes prior to the scheduled start time.
A replay of the webcast will also be archived on the Company's website for 90 days following the call. A replay of the call will be available for 90 days within a few hours after the call ends. Investors may listen to the replay of the call by dialing 888-203-1112 (domestic) or +1-719-457-0820 (international), with the passcode 9170164.
About Migraine and Migraine-Related Nausea (MRN)
Migraine is a debilitating neurological disease afflicting a large underserved patient population. Migraine is characterized by headache pain accompanied by associated neurological and GI symptoms including nausea, vomiting, photophobia, and phonophobia.1,2 In the U.S., 31 million adults, with approximately three times as many women as men,3 suffer from migraine.3,4,5 Of the 16 million migraine patients who are diagnosed and treated, approximately eight million experience migraine-related nausea (MRN) in at least half of their migraine attacks.6 These frequent-MRN patients report significantly more migraine symptom burden and experience significantly more interference with work, social and family life.6 Many migraine patients who experience MRN delay or avoid taking orally administered medications due to nausea or vomiting.7
About NuPathe
NuPathe Inc. is a specialty pharmaceutical company focused on innovative neuroscience solutions for diseases of the central nervous system including neurological and psychiatric disorders. NuPathe's lead product, Zecuity (sumatriptan iontophoretic transdermal system), has been approved by the FDA for the acute treatment of migraine with or without aura in adults. Zecuity is expected to be available by prescription in the fourth quarter of 2013. In addition to Zecuity, NuPathe has two proprietary product candidates based on its LAD™, or Long-Acting Delivery, biodegradable implant technology that allows delivery of therapeutic levels of medication over a period of months with a single dose. NP201, for the continuous symptomatic treatment of Parkinson's disease, utilizes a leading FDA-approved dopamine agonist, ropinirole, and is being developed to provide up to two months of continuous delivery. NP202, for the long-term treatment of schizophrenia and bipolar disorder, is being developed to address the long-standing problem of patient noncompliance by providing three months of continuous delivery of risperidone, an atypical antipsychotic. NuPathe is actively seeking partnerships to maximize the commercial potential for Zecuity and its other product candidates in the U.S. and territories throughout the world.
For more information about NuPathe, please visit our website and our blog at www.nupathe.com. You can also follow us on StockTwits (stocktwits.nupathe.com), Twitter (twitter.nupathe.com), SlideShare (slideshare.nupathe.com) and LinkedIn (linkedin.nupathe.com).
Cautionary Note Regarding Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. All statements that are not historical facts are hereby identified as forward-looking statements for this purpose and include, among others, statements relating to: the potential benefits of, and commercial opportunity for, Zecuity and NuPathe's other product candidates; partnering plans for Zecuity and NuPathe's other product candidates; the timing of the expected launch and availability of Zecuity; and other statements relating to NuPathe's plans, objectives, expectations and beliefs regarding its future operations, performance, financial condition and other future events. Forward-looking statements are based upon management's current expectations and beliefs and are subject to a number of risks, uncertainties, assumptions and other factors that could cause actual results and events to differ materially from those indicated herein including, among others: NuPathe's ability to obtain sufficient capital to launch Zecuity; NuPathe's ability to obtain commercial and development partners for Zecuity and its other product candidates; NuPathe's reliance on third parties to manufacture Zecuity; NuPathe's ability to establish and effectively manage its supply chain; NuPathe's ability to establish effective marketing and sales capabilities; market acceptance among physicians and patients and the availability of adequate reimbursement from third party payors for Zecuity; and the risks, uncertainties and other factors discussed in NuPathe's Annual Report on Form 10-K for the year ended December 31, 2010 and Quarterly Report on Form on Form 10-Q for the quarter ended September 30, 2012 under the caption "Risk Factors" and elsewhere in such reports, which are available on NuPathe's website at www.nupathe.com in the "Investor Relations -- SEC Filings" section. While NuPathe may update certain forward-looking statements from time to time, it specifically disclaims any obligation to do so, whether as a result of new information, future developments or otherwise. You are cautioned not to place undue reliance on any forward-looking statements.
References
1. ICHD-II. Cephalagia 2004; 24 (Suppl 1).
2. Lipton, R. et al. Classification of primary headaches. Neurology. 2004:63:427-435.
3. Lipton, R. et al. Prevalence and Burden of Migraine in the United States: Data From the American Migraine Study II. Headache, July/August 2001: p. 646.
4. US Census Data. 1999, accessed at http://www.census.gov/prod/2001pubs/p23-205.pdf 01/03/13; and 2010, accessed at http://www.census.gov/2010census/data/.
5. NuPathe Analysis.
6. Lipton, R. et al. "Frequency and Burden of Headache-Related Nausea: Results from the American Migraine Prevalence and Prevention (AMPP) Study." Headache 2012:53:93-103. Funded by a research grant from NuPathe Inc.
7. Silberstein, S. Migraine symptoms: results of a survey of self-reported migraineurs. Headache 1995;35:387-396.
Contact Information:
INVESTOR CONTACTS
Westwicke Associates
John Woolford
(443) 213-0506
john.woolford@westwicke.com
MEDIA CONTACTS:
6 Degrees
Tony Plohoros
(908) 940-0135
tplohoros@6degreespr.com
Sage Strategic Marketing
Jennifer Guinan
(610) 410-8111
jennifer@sagestrat.com
related links
CEO Q&A
Driving Shareholder Value
Publications & Presentations
Contacts
Investors
Westwicke Partners, LLC
443.213.0506
John Woolford
Media
Sage Strategic Marketing
610.410.8111
Jennifer Guinan
news kam aber bei den amis nicht so gut an.keine ahnung warum.nähe tagestief deutet auf weiter fallende kurse hin morgen.
Sieht gut aus. Jeder der unter Migräe leidet, weiss warum wir steigen.
Ich sag nur Nebenwirkungen ...
Spreche aus Erfahrung. 16 Jahre Leidensweg ...
Mein persönliches Kusziel bis Gapclose ca. 8,00$ bis Mitte des Jahres, wenn ein Partner vorgestellt wird.
Ich sag nur Nebenwirkungen ...
Spreche aus Erfahrung. 16 Jahre Leidensweg ...
Mein persönliches Kusziel bis Gapclose ca. 8,00$ bis Mitte des Jahres, wenn ein Partner vorgestellt wird.
Antwort auf Beitrag Nr.: 44.050.286 von jojobada am 22.01.13 18:17:55ups: Migräne
Antwort auf Beitrag Nr.: 44.050.286 von jojobada am 22.01.13 18:17:55na ja, mal den Tag nicht vor dem Abend loben, das Ding kann auch noch heute im minus enden. Alles möglich, wie man am Freitag gesehen hatte.
mehr gibt,s nicht zu sagen. Liegen und Laufen lassen
Wenn deine Frau zu Dir sagt, dass sie Migräne hat gilt ab heute nicht mehr ...
Kauf dat dingen und ruh ist
Kleiner Scherz
Sorry ...
Kauf dat dingen und ruh ist
Kleiner Scherz
Sorry ...
NuPath steht mit ihren Errungenschaften ganz am Anfang. Bin gespannt wie es weitergeht.
Sonst noch jemand hier?
Gruß jojo
Sonst noch jemand hier?
Gruß jojo
Zitat von jojobada: NuPath steht mit ihren Errungenschaften ganz am Anfang. Bin gespannt wie es weitergeht.
Sonst noch jemand hier?
Gruß jojo
Hallo,
ja ich.....bin seit dem approval investiert...
Ich lasse Sie (Gewinn) weiter laufen....
Mal sehen ob sich kurzfristig ein Partner (Major) für die Produktion und Vermarktung aufzeigt.
Interessant wäre eine Schätzung über den zu erwartenden Marktanteil und zu erwartenden Cashflow.....und was Netto unterm Strich übrig bleibt
Bei der rel geringen Gesamtsharezahl von rund 14 MIO...könnte Nupathe noch explodieren...
Eine Übernahme ist natürlich auch möglich...
Desweiteren wird wohl auch die Zulassung für Europa irgendwann ins Auge gefasst ( meine Vermutung !)
Aber schaun wir mal.............
Momentum schaut gut aus...
Grüße Earthfire
Antwort auf Beitrag Nr.: 44.058.330 von jojobada am 24.01.13 12:08:45Hast du die Fillings schon gesehen ( vom 22/1/13)...
http://www.nasdaq.com/symbol/path/sec-filings#.UQEfhWdDCEI
http://www.nasdaq.com/symbol/path/sec-filings#.UQEfhWdDCEI
Antwort auf Beitrag Nr.: 44.058.545 von Earthfire am 24.01.13 12:42:27
na ja, das Teil sieht eher nach ner Lusche aus. Stürzt ab.
na ja, das Teil sieht eher nach ner Lusche aus. Stürzt ab.
Zitat von i2fan:![]()
na ja, das Teil sieht eher nach ner Lusche aus. Stürzt ab.
Wobei Absturz aber eher als relativ zu betrachten ist...
fällt unter geringem Volumen heute....
solche" kleinen" Kurschwankungen sind bei Biotecpapieren normal und ändern nichts an der Sache.....
An Tagen mit schwacher Nachfrage wird oft Hedgefonds gedrückt
Ich bleib drin
Antwort auf Beitrag Nr.: 44.060.952 von Earthfire am 24.01.13 19:52:49ich bleibe auch drin
Antwort auf Beitrag Nr.: 44.060.998 von i2fan am 24.01.13 20:00:31immer noch nur watchlist da ich zu 2,45 keine bekommen habe.bin gestern unter anderen mal in ne andere bude rein.nur aus rein charttechnischer sicht sieht es sehr gut aus.die könnte nächste woche durchstarten. US23703P2056
grüße
grüße
Die ganzen Tage wurde nachbörslich keine Aktie gehandelt. Doch was ist das jetzt? Hat das was zu sagen? Vielleicht auch nicht?
http://www.nasdaq.com/symbol/path/after-hours#.UQnlX_IoSho
http://www.nasdaq.com/symbol/path/after-hours#.UQnlX_IoSho
http://www.nasdaq.com/symbol/path/after-hours#.UQnlX_IoSho
http://www.nasdaq.com/symbol/path/after-hours#.UQnlX_IoSho
Die spinnen die Amis ... 
Antwort auf Beitrag Nr.: 44.088.876 von jojobada am 31.01.13 18:23:35wenns morgen noch mal genau so viel weiter runter geht,
könnte man wieder ans nachkaufen denken.
könnte man wieder ans nachkaufen denken.
Antwort auf Beitrag Nr.: 44.089.378 von Earthfire am 31.01.13 19:58:44was ist hier nur los. wollte hier auch rein aber die ist ja sowas von schwach.phantasie ist doch eigentlich da.ich schau noch bissl zu.mal sehn wann ich rein gehe.
wollte hier auch rein aber die ist ja sowas von schwach.phantasie ist doch eigentlich da.ich schau noch bissl zu.mal sehn wann ich rein gehe.
Antwort auf Beitrag Nr.: 44.102.346 von Earthfire am 04.02.13 20:51:49sieht so aus als wenns erst noch auf 3 Dollar fällt.
Die 3,00 Dollar kommen immer näher.
Die 3,00 Dollar kommen immer näher.
Antwort auf Beitrag Nr.: 44.106.349 von i2fan am 05.02.13 18:41:14dillition?????? alleine könn die das ding ja nicht stemmen.
Antwort auf Beitrag Nr.: 44.107.552 von ultrawuffsn am 06.02.13 04:15:45nein das nicht, dafür ist ja zu wenig Umsatz.
Hi, noch jemand da ? 
Also die 3$ werden wir meiner Meinung nach nicht mehr sehen....
Denke das bald die 4 $ fallen (heute ?)....und dann erst mal Downgap close bis in den Bereich 4,3 $...evtl. läuft sie auch bis 5 $ durch....mal sehen
Ich bin Long und werde vor 7 $ nicht verkaufen...
Die Instis sind auch interessiert :
Mal hier schauen....was da so passiert :
http://www.nasdaq.com/symbol/path/sec-filings#.UR4WmGdDCEI
Also die 3$ werden wir meiner Meinung nach nicht mehr sehen....
Denke das bald die 4 $ fallen (heute ?
)....und dann erst mal Downgap close bis in den Bereich 4,3 $...evtl. läuft sie auch bis 5 $ durch....mal sehen Ich bin Long und werde vor 7 $ nicht verkaufen...
Die Instis sind auch interessiert :
Mal hier schauen....was da so passiert :
http://www.nasdaq.com/symbol/path/sec-filings#.UR4WmGdDCEI
Antwort auf Beitrag Nr.: 44.144.994 von Earthfire am 15.02.13 12:15:55ja, noch da.
Sieht so aus, als wärs nix mehr mit 3 $
Sieht so aus, als wärs nix mehr mit 3 $
Zitat von i2fan: ja, noch da.
Sieht so aus, als wärs nix mehr mit 3 $
Nein 3$ hatte ich auch vorher nicht gedacht....hier lag mein erster Kauf.
Mit dem Nachkauf habe ich einen schönen Mischkurs...bei meiner Positionsgröße.
Ich denke das wir in Kürze hören werden wie es weitergeht bei der Vermarktung!!
Immer schwer einzuschätzen....aber ich denke der derzeitige MK ist ein Witz.
Mal sehen ob die bald einen BIG-Player als Partner verkünden können...der die Vermarktung und die Produktion übernimmt ?
Antwort auf Beitrag Nr.: 44.147.441 von Earthfire am 15.02.13 19:32:19nun droht die 3,50 Dollar Grenze zu fallen.
Was kommt eher, die 3,00 oder 4,00 ?
Was kommt eher, die 3,00 oder 4,00 ?
Antwort auf Beitrag Nr.: 44.183.635 von i2fan am 25.02.13 17:21:36
sieht nun so aus als wären die 3 Dollar doch noch drin.
sieht nun so aus als wären die 3 Dollar doch noch drin.
Antwort auf Beitrag Nr.: 44.189.944 von Earthfire am 26.02.13 22:12:30zumindest sind die 3,00 näher als die 4,00
Antwort auf Beitrag Nr.: 44.199.235 von Earthfire am 28.02.13 18:07:21na ja, hin und her macht Taschen leer.
Zitat von i2fan: na ja, hin und her macht Taschen leer.
Börsenfloskel
....bin hier mit 10 % Plus raus....und da aktuell bei 30 % Plus.Taschen leer....kann ich also bei mir nicht erkennen.
Wenn sich ein besseres Potenzial bietet, muss man schnell handeln...meine Meinung...und Erfahrung !
Viel Erfolg hier, evtl. steige ich ja nochmal ein !
Antwort auf Beitrag Nr.: 44.188.739 von i2fan am 26.02.13 17:45:34nun dauerts nicht mehr lange bis zu den 3,00
Antwort auf Beitrag Nr.: 44.217.780 von i2fan am 05.03.13 20:38:48ist nun sogar unter 3 Dollar gefallen
Nu Pathe befindet sich mindestens seit Mitte Janauar in einer Abwärtsbewegung, die sich seit April sogar verstärkt hat. Mit dem jüngsten Kursrückgang wurde auch das Tief aus dem Januar unterschritten und dies mit einem gesteigeigerten Handelsvolumen. Eine wirkliche Unterstützung ist erstmal nicht auszumachen. Als einzige Marke bleibt das 52Wochen-Tief vom November, das bei 2,57$ liegt
Auch fundamental scheint man momentan nicht überzeugen zu können, da man das von den Analysten vorhergesagte Q1-Ergebnis von -0,17$ mit -0,68$ mehr als deutlich verfehlte.
Weiss jemand wann die Q2 Zahlen kommen sollen? Erwartet werden dort -0,2$.
Auch fundamental scheint man momentan nicht überzeugen zu können, da man das von den Analysten vorhergesagte Q1-Ergebnis von -0,17$ mit -0,68$ mehr als deutlich verfehlte.
Weiss jemand wann die Q2 Zahlen kommen sollen? Erwartet werden dort -0,2$.
Antwort auf Beitrag Nr.: 44.814.037 von i2fan am 09.06.13 11:42:34
Es könnte sich ab Montag hier was tun, ist am Freitag gegen Ende etwas hochgeganngen.
Es könnte sich ab Montag hier was tun, ist am Freitag gegen Ende etwas hochgeganngen.
Antwort auf Beitrag Nr.: 44.814.037 von i2fan am 09.06.13 11:42:34sieht so aus als würde das Ding hier auch noch bald unter 2 dollar fallen
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