Durect! Ein Phönix aus der Asche oder nur eine Luftnummer??? - 500 Beiträge pro Seite

[Lucky72]

Bin mit einer kleinen Posi eingestiegen!

[Lucky72]

Link zur HP http://www.durect.com/

[Lucky72]

[Lucky72]

DURECT Announces Top-line Results from the PERSIST Phase 3 Trial of POSIMIR® (SABER®-Bupivacaine) Did Not Meet Primary Efficacy Endpoint

CUPERTINO, Calif., Oct. 19, 2017 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) today reported that PERSIST, the Phase 3 clinical trial for POSIMIR® (SABER®-Bupivacaine), did not meet its primary efficacy endpoint of reduction in pain on movement over the first 48 hours after surgery as compared to standard bupivacaine HCl. While results trended in favor of POSIMIR versus the comparator, they did not achieve statistical significance. POSIMIR is an investigational drug candidate being developed for the treatment of post-surgical pain.

"We are very surprised and disappointed by these results, which we will be trying to understand more fully over the coming weeks," said James E. Brown, President and CEO of DURECT Corporation. "We appreciate the efforts of the investigators and patients who participated in PERSIST, and we thank Sandoz for their support."

About POSIMIR (SABER-Bupivacaine)

POSIMIR is an investigational extended-release depot utilizing DURECT's patented SABER technology intended to continuously deliver bupivacaine to the surgical site for 72 hours to provide up to three days of continuous pain relief after surgery. POSIMIR is a drug candidate under development and has not been approved for commercialization by the U.S. Food and Drug Administration or other health authorities.

About the DURECT / Sandoz Collaboration

In May 2017, DURECT and Sandoz AG ("Sandoz") entered into a license agreement to develop and market POSIMIR in the United States, and the agreement became effective in June 2017. DURECT retains commercialization rights in the rest of the world. Under terms of the agreement, Sandoz made an upfront payment of $20 million, with the potential for up to an additional $43 million in milestone payments based on successful development and regulatory milestones, and up to an additional $230 million in sales-based milestones. DURECT is responsible for the completion of the ongoing PERSIST Phase 3 clinical trial for POSIMIR as well as FDA interactions through approval. DURECT also has certain manufacturing obligations under this agreement. Sandoz will have exclusive commercialization rights in the United States upon regulatory approval with sole funding responsibility for commercialization activities. Sandoz will pay the Company a tiered double-digit royalty on product sales for a defined period, after which the license granted to Sandoz shall convert to a non-exclusive, fully paid, royalty-free, irrevocable and perpetual license. Given the failure of PERSIST to achieve the primary endpoint, Sandoz has the right to terminate the agreement upon thirty (30) days prior written notice to DURECT.

About DURECT

DURECT is a biopharmaceutical company actively developing new therapeutics based on its Epigenetic Regulator Program and proprietary drug delivery platforms. DUR‑928, a new chemical entity in Phase 1 development, is the lead candidate in DURECT's Epigenetic Regulator Program. An endogenous, orally bioavailable small molecule, DUR-928 has been shown in preclinical studies to play an important regulatory role in lipid homeostasis, inflammation, and cell survival. Human applications may include acute organ injury, chronic metabolic diseases such as nonalcoholic fatty liver disease (NAFLD), nonalcoholic steatohepatitis (NASH) and other liver diseases with both broad and orphan populations, and inflammatory skin conditions such as psoriasis. DURECT's advanced oral, injectable, and transdermal delivery technologies are designed to enable new indications and enhanced attributes for small-molecule and biologic drugs. One late-stage product candidate in this category is POSIMIR® (SABER®-Bupivacaine), an investigational locally-acting, non-opioid analgesic intended to provide up to 3 days of continuous pain relief after surgery. Another late stage product candidate is REMOXY® ER (oxycodone), an investigational pain control drug based on DURECT's ORADUR® technology. In addition, for the assignment of certain patent rights, DURECT may receive a milestone payment from development and single digit sales based earn-out payments from sale of Indivior's RBP-7000 investigational drug for schizophrenia, for which Indivior recently submitted an NDA. For more information, please visit www.durect.com.

NOTE: POSIMIR®, SABER®, and ORADUR® are trademarks of DURECT Corporation. Other referenced trademarks belong to their respective owners. POSIMIR, DUR-928 and REMOXY ER are drug candidates under development and have not been approved for commercialization by the U.S. Food and Drug Administration or other health authorities.

DURECT Forward-Looking Statement

The statements in this press release regarding the potential benefits and uses of our drug candidates, including the potential use of POSIMIR to treat post-surgical pain, the potential milestone payments and royalties receivable from Sandoz, the potential milestone payment and single-digit sales based earn-out payments receivable from Indivior, and the potential use of DUR-928 to treat NAFLD, NASH, other liver diseases, acute organ injury or inflammatory skin conditions such as psoriasis are forward-looking statements involving risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. Potential risks and uncertainties include, but are not limited to, the risks that Sandoz will terminate our agreement with them, that the results of the PERSIST trial lead us to terminate development of POSIMIR or increase the time and expense required to seek regulatory approval, and the risk that DUR-928 will not be found to be safe or effective in current or future clinical trials. Further information regarding these and other risks is included in DURECT's Form 10-Q filed on August 5, 2017 under the heading "Risk Factors."


http://investors.durect.com/phoenix.zhtml?c=121590&p=irol-ne…

[Lucky72]

Ich finde den Kurseinbruch am Freitag um 60% für übertrieben!

Die Pipeline von Durect ist doch vielversprechend!

[Lucky72]

[Lucky72]

Antwort auf Beitrag Nr.: 56.021.100 von Lucky72 am 25.10.17 10:15:53

Zitat von Lucky72: Ich finde den Kurseinbruch am Freitag um 60% für übertrieben!

Die Pipeline von Durect ist doch vielversprechend!

[Lucky72]

Nächste Woche gets um die Wurst!


DURECT Corporation Invites You to Join its Third Quarter 2017 Earnings Conference Call

CUPERTINO, Calif., Oct. 26, 2017 /PRNewswire/ -- In conjunction with DURECT Corporation's (Nasdaq: DRRX) third quarter 2017 financial results press release, you are invited to listen to a conference call that will be broadcast live over the internet on Wednesday, November 1, 2017 at 4:30 pm Eastern Time (1:30 pm Pacific Time).

A live audio webcast of the presentation will be available by accessing DURECT's homepage at www.durect.com and clicking "Investor Relations." If you are unable to participate during the live webcast, the call will be archived on DURECT's website under Audio Archive in the "Investor Relations" section.

About DURECT Corporation

DURECT is a biopharmaceutical company developing therapeutics based on its Epigenetic Regulator Program and proprietary drug delivery platforms. DUR‑928, a new chemical entity in Phase 1 development, is the lead candidate in DURECT's Epigenetic Regulator Program. An endogenous, orally bioavailable small molecule, DUR-928 has been shown in preclinical studies to play an important regulatory role in lipid homeostasis, inflammation, and cell survival. Human applications may include acute organ injury, chronic metabolic diseases such as nonalcoholic fatty liver disease (NAFLD), nonalcoholic steatohepatitis (NASH) and other liver diseases with both broad and orphan populations, and inflammatory skin conditions such as psoriasis. DURECT's advanced oral, injectable, and transdermal delivery technologies are designed to enable new indications and enhanced attributes for small-molecule and biologic drugs. One late-stage product candidate in this category is POSIMIR® (SABER®-Bupivacaine), an investigational locally-acting, non-opioid analgesic intended to provide up to 3 days of continuous pain relief after surgery. Another late stage product candidate is REMOXY® ER (oxycodone), an investigational pain control drug based on DURECT's ORADUR® technology. In addition, for the assignment of certain patent rights, DURECT may receive a milestone payment upon NDA approval and single digit sales-based earn-out payments from U.S. net sales of Indivior's RBP-7000 investigational drug for schizophrenia, for which Indivior recently submitted an NDA. For more information, please visit www.durect.com.

NOTE: POSIMIR®, SABER®, and ORADUR® are trademarks of DURECT Corporation. Other referenced trademarks belong to their respective owners. POSIMIR, REMOXY ER, RBP-7000 and DUR-928, are investigational drugs under development and have not been approved for sale by the U.S. Food and Drug Administration or other health authorities.

http://investors.durect.com/phoenix.zhtml?c=121590&p=irol-ne…

[Lucky72]

Sieht nach Bodenbildung aus!

[Lucky72]

CUPERTINO, Calif., Nov. 1, 2017 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) today announced financial results for the three months ended September 30, 2017 and provided a corporate update.

Executed a patent purchase agreement with Indivior relevant to Indivior's RBP-7000, yielding DURECT a $12.5 million upfront payment, as well as a potential $5 million milestone payment and potential earn-out payments. Indivior submitted a NDA for RBP-7000 to the U.S. FDA on September 28, 2017.
Including the $12.5 million described above, total revenues were $20.7 million and net income was $6.1 million for the three months ended September 30, 2017 as compared to total revenues of $3.7 million and net loss of $8.8 million for the three months ended September 30, 2016.
At September 30, 2017, cash and investments were $41.8 million, compared to cash and investments of $25.2 million at December 31, 2016.

"The top-line results from the Phase 3 clinical trial of POSIMIR did not meet expectations, trending in favor of POSIMIR but not reaching statistically significance. We will be working to understand the trial results more fully in the coming weeks," stated James E. Brown, D.V.M., President and CEO of DURECT. "On other fronts, positive highlights of the third quarter included reaching an agreement with Indivior which resulted in a meaningful upfront payment to DURECT as well the potential for further payments based on the progress of RBP-7000, a drug candidate for schizophrenia for which Indivior has submitted an NDA to the FDA. We are also making significant progress towards initiating multiple Phase 2 studies with DUR-928."

Update on Selected Programs and Transactions:

POSIMIR (SABER®-Bupivacaine) Post-Operative Pain Relief Depot. POSIMIR is our investigational post-operative pain relief depot that utilizes our patented SABER technology and is designed to deliver bupivacaine to provide up to 3 days of pain relief after surgery.

In October 2017, we reported that PERSIST, a Phase 3 clinical trial for POSIMIR did not meet its primary efficacy endpoint of reduction in pain on movement over the first 48 hours after surgery as compared to standard bupivacaine HCl. While results trended in favor of POSIMIR versus the comparator, they did not achieve statistical significance. We and Sandoz, our licensee for commercialization rights for POSIMIR in the United States, will be working to understand the trial results more fully in the coming weeks.

Epigenetic Regulator Program. DUR-928, the lead product candidate in our Epigenetic Regulator Program, is an endogenous, small molecule, new chemical entity (NCE), which may have broad applicability in several metabolic diseases such as nonalcoholic steatohepatitis (NASH) and other disorders of the liver, in acute organ injuries such as acute liver and/or kidney injury, and in autoimmune/inflammatory skin disorders such as psoriasis and atopic dermatitis.

Oral Administration

We are actively working towards initiating a Phase 2 trial in primary sclerosing cholangitis (PSC) with orally administered DUR-928. Our protocol has been reviewed by the FDA and our IND is now open. Clinical trial site preparation is underway, and we are targeting dosing our first patient by the end of 2017. PSC is a chronic liver disease characterized by a progression of cholestasis (decrease in bile flow) with inflammation and fibrosis of bile ducts. We have received orphan drug designation for DUR-928 to treat patients with PSC. We believe that data generated from this trial will be relevant to other chronic liver conditions, such as NASH.

Injectable Administration

We now have an open IND for an initial Phase 2 trial with an injectable formulation of DUR-928. We are currently finalizing the protocol based on detailed input received in October 2017 from our expert advisors during The Liver Meeting® (the annual meeting of the American Association for the Study of Liver Diseases or AASLD). This first study will be conducted in patients with moderate and severe acute liver function impairment to assess the safety and pharmacokinetics of several doses of DUR-928.
At AASLD, a poster was presented by Dr. Shunlin Ren of Virginia Commonwealth University / McGuire VA Medical Center which included newly disclosed data from animal studies with DUR-928 in various acute organ injuries. One of the new disclosures was the dose-dependent effect of DUR-928 in stabilizing mitochondrial membranes, which is an important factor in cell viability and prevention of cell death. Previous results had been reported with DUR-928 in an acute animal model where the toxicity was caused by lipopolysaccharide (LPS); in this poster, similar results (i.e., 90% survival with DUR-928 vs. 10% survival on placebo) were shown when the toxicity was caused by injected acetaminophen. This poster also demonstrated the pharmacological effect of DUR-928 in animal models of both endotoxin and drug induced multiple organ injuries, including the liver, the kidney and the lungs. This poster is available at www.durect.com under Science and Technologies, Papers.

Topical Administration

Based on promising results from a previous exploratory Phase 1b trial in psoriasis utilizing intralesional micro injections of DUR-928, we have developed topical formulations of DUR-928 and have recently completed GLP skin irritation / sensitization studies with the lead formulations in two species. We have had pre-IND interactions with the FDA and are incorporating FDA's comments in our upcoming IND while we are actively working with expert advisors to finalize our study protocol for a Phase 2 proof-of-concept study with topically applied DUR-928. We expect to initiate this study in the first half of 2018. We believe that there is a large market opportunity for new topical drugs for inflammatory skin diseases such as psoriasis and atopic dermatitis.

Indivior Agreement. In September 2017, we entered into a patent purchase agreement with an affiliate of Indivior PLC, whereby DURECT assigned certain of its U.S. patent rights to Indivior. This assignment may provide further intellectual property protection for RBP-7000, Indivior's investigational once-monthly injectable risperidone product for the treatment of schizophrenia. Indivior submitted a New Drug Application (NDA) for RBP-7000 to the U.S. Food and Drug Administration (FDA) on September 28, 2017.

Under the terms of the agreement, Indivior has made an upfront non-refundable payment to DURECT of $12.5 million, with the potential for an additional $5 million based on NDA approval of RBP-7000, as well as quarterly earn-out payments that are based on a single digit percentage of U.S. net sales for certain products covered by the patent rights, including RBP-7000. The patent rights include granted patents extending through at least 2026.

REMOXY® ER (oxycodone) Extended-Release Capsules CII. Based on our ORADUR technology, the investigational drug REMOXY ER is a unique long-acting formulation of oxycodone designed to discourage common methods of tampering associated with opioid misuse and abuse. In March 2017, Pain Therapeutics announced that it plans to resubmit the REMOXY ER NDA after completing two additional studies regarding REMOXY ER based on guidance obtained in a meeting with the FDA. The two studies are a clinical abuse potential study via the intranasal route of abuse and a non-clinical abuse potential study using household solvents. Pain Therapeutics stated that it expects to complete these studies by year end 2017. In October 2017, Pain Therapeutics announced that there is a pre-NDA guidance meeting with the FDA planned for November 14, 2017 and Pain Therapeutics is planning an NDA resubmission in the first quarter of 2018.

ORADUR-ADHD Program. ORADUR-Methylphenidate ER is an investigational drug that has the potential for rapid onset of action and long duration with once-a-day dosing, utilizes a small capsule size relative to the leading existing long-acting products on the market and incorporates our ORADUR anti-tampering technology. Orient Pharma, our licensee in defined Asian and South Pacific countries, has reported that a Phase 3 study conducted in Taiwan has achieved positive results. We retain rights to all other markets in the world, notably including the U.S., Europe and Japan. We have started a process of contacting potential development and commercialization partners for major markets not licensed to Orient Pharma.

Upcoming investor conference. DURECT will be presenting at the Stifel 2017 Healthcare Conference at 11:45 am Eastern time on November 15. The conference is being held at the Lotte New York Palace Hotel. A live audio webcast of the presentation will be available by accessing http://wsw.com/webcast/stifel10/drrx . A live audio webcast of these presentations will also be available by accessing DURECT's homepage at www.durect.com and clicking "Investor Relations." If you are unable to participate during the live webcast, the call will be archived on DURECT's website under Audio Archive in the "Investor Relations" section.

Earnings Conference Call
A live audio webcast of a conference call to discuss third quarter 2017 results and provide a corporate update will be broadcast live over the internet at 4:30 p.m. Eastern Time on November 1 and is available by accessing DURECT's homepage at www.durect.com and clicking "Investor Relations." If you are unable to participate during the live webcast, the call will be archived on DURECT's website under Audio Archive in the "Investor Relations" section.

About DURECT Corporation

DURECT is a biopharmaceutical company developing therapeutics based on its Epigenetic Regulator Program and proprietary drug delivery platforms. DUR‑928, a new chemical entity in Phase 1 development, is the lead candidate in DURECT's Epigenetic Regulator Program. An endogenous, orally bioavailable small molecule, DUR-928 has been shown in preclinical studies to play an important regulatory role in lipid homeostasis, inflammation, and cell survival. Human applications may include acute organ injury, chronic metabolic diseases such as nonalcoholic fatty liver disease (NAFLD), nonalcoholic steatohepatitis (NASH) and other liver diseases with both broad and orphan populations, and inflammatory skin conditions such as psoriasis. DURECT's advanced oral and injectable delivery technologies are designed to enable new indications and enhanced attributes for small-molecule and biologic drugs. One product candidate in this category is POSIMIR® (SABER®-Bupivacaine), an investigational locally-acting, non-opioid analgesic intended to provide up to 3 days of continuous pain relief after surgery. Another product candidate is REMOXY® ER (oxycodone), an investigational pain control drug based on DURECT's ORADUR® technology. In addition, for the assignment of certain patent rights, DURECT may receive a milestone payment upon NDA approval and single digit sales-based earn-out payments from U.S. net sales of Indivior's RBP-7000 investigational drug for schizophrenia, for which Indivior submitted an NDA on September 28, 2017. For more information, please visit www.durect.com.

NOTE: POSIMIR®, SABER®, and ORADUR® are trademarks of DURECT Corporation. Other referenced trademarks belong to their respective owners. POSIMIR, DUR-928, RBP-7000, REMOXY ER and ORADUR-Methylphenidate ER are drug candidates under development and have not been approved for commercialization by the U.S. Food and Drug Administration or other health authorities.

DURECT Forward-Looking Statement

The statements in this press release regarding potential future payments from Indivior, clinical trial plans for DUR-928, including the potential commencement of clinical trials in primary sclerosing cholangitis, moderate and severe acute liver function impairment, and psoriasis, the potential benefits and uses of our drug candidates, including the potential use of DUR-928 to treat PSC, other disorders of the liver, kidney diseases, acute organ injuries, or psoriasis or other inflammatory conditions, the potential use of POSIMIR to treat pain, the potential abuse deterrent properties of REMOXY ER, the potential use of RBP-7000 to treat schizophrenia, and the potential use of ORADUR-Methylphenidate ER to treat ADHD, potential markets for our product candidates, Indivior's plans for RBP-7000, Pain Therapeutics' plans for REMOXY ER and our plans to seek a licensee for ORADUR-Methylphenidate ER are forward-looking statements involving risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. Potential risks and uncertainties include, but are not limited to, the risks that future clinical trials of DUR-928 are not started when anticipated or do not demonstrate the safety or efficacy of DUR-928 in a statistically significant manner, that Pain Therapeutics may not be able to adequately address all of FDA's concerns regarding the REMOXY ER NDA or that there could be a delay in addressing such concerns, the potential that FDA may not grant regulatory approval of POSIMIR, or REMOXY ER, the risks of obtaining marketplace acceptance of POSIMIR, RBP-7000 or REMOXY ER, if approved, the risk that Sandoz may terminate our agreement with them and discontinue plans to commercialize POSIMIR, the risk that prior clinical trials (including prior Phase 1b trials of DUR-928) will not be confirmed in subsequent trials, the potential failure of clinical trials to meet their intended endpoints, the risk that Pain Therapeutics, Indivior or Orient Pharma will discontinue development of REMOXY ER, RBP-7000 or ORADUR-Methylphenidate ER, respectively, or be delayed in development or regulatory submissions, the risk that additional time and resources that may be required for development, testing and regulatory approval of POSIMIR or DUR-928, potential adverse effects arising from the testing or use of our drug candidates, our potential failure to maintain our collaborative agreements with third parties or consummate new collaborations and risks related to our ability to obtain capital to fund operations and expenses. Further information regarding these and other risks is included in DURECT's Form 10-Q filed on August 9, 2017 under the heading "Risk Factors."

DURECT CORPORATION

CONDENSED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)



https://www.prnewswire.com/news-releases/durect-corporation-…

[Lucky72]

Es wird langsam wieder Zeit für News!

[Lucky72]

http://stockcharts.com/h-sc/ui?s=DRRX&p=D&yr=0&mn=3&dy=0&id=…

[hamitc]

Antwort auf Beitrag Nr.: 56.363.088 von Lucky72 am 04.12.17 21:03:59

Gute Nachrichten von Durect.

Erbenisse sind super und die Aussichten sehen auch gut aus, PDUFA am 28.07.2018

Die Aktie könnte jetzt an Schwung gewinnen.
Beste Grüße.

[hamitc]

Antwort auf Beitrag Nr.: 57.165.225 von hamitc am 01.03.18 23:12:56

Sorry, hab den link vergessen:

https://finance.yahoo.com/news/durect-corporation-announces-…

[Lucky72]

AH sehen wir die Richtung!

https://www.nasdaq.com/de/symbol/drrx/after-hours

[Lucky72]

DURECT Announces FDA Advisory Committee Meeting for REMOXY® ER

CUPERTINO, Calif., March 20, 2018 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) today announced that its licensee, Pain Therapeutics (Nasdaq: PTIE), reported yesterday that the U.S. Food and Drug Administration (FDA) will hold an Advisory Committee Meeting to discuss the New Drug Application (NDA) for REMOXY ER (extended release oxycodone CII). REMOXY® ER is designed as an abuse-deterrent, extended release, capsule formulation of oxycodone, a prescription drug for severe pain. The tentative date for the Advisory Committee Meeting is June 26, 2018. The Prescription Drug User Fee Act (PDUFA) target date for the REMOXY ER NDA is August 7, 2018.

About REMOXY ER

REMOXY ER, an investigational drug, is a unique long-acting oral formulation of oxycodone intended to manage pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Based on DURECT's ORADUR® technology, which is covered by issued patents and pending patent applications owned by us, REMOXY ER is designed to discourage common methods of tampering associated with prescription opioid analgesic misuse and abuse.

In December 2002, DURECT licensed to Pain Therapeutics worldwide rights to develop and commercialize REMOXY ER and other oral sustained release drug candidates that use the ORADUR technology and incorporate certain specified opioid compounds. DURECT, which is reimbursed for formulation and other work performed under its agreement with Pain Therapeutics, will receive additional payments if certain development and regulatory milestones are achieved with respect to REMOXY ER, and will receive royalties of between 6.0% to 11.5% of net sales if REMOXY ER is commercialized, as well as a mark-up on DURECT's supply of key excipients used in the manufacture of REMOXY ER.

About ORADUR Technology

ORADUR is a proprietary technology designed to transform short-acting oral capsule dosage forms into sustained release oral products, with the added benefit of resisting common methods of prescription drug misuse and abuse compared to other controlled release dosage forms on the market today.

About DURECT

DURECT is a biopharmaceutical company actively developing new therapeutics based on its Epigenetic Regulator Program and proprietary drug delivery platforms. DUR-928, a new chemical entity in Phase 2 development, is the lead candidate in DURECT's Epigenetic Regulator Program. An endogenous, orally bioavailable small molecule, DUR-928 has been shown in preclinical studies to play an important regulatory role in lipid homeostasis, inflammation, and cell survival. Human applications may include acute organ injury such as alcoholic hepatitis, hepatic and renal diseases such as nonalcoholic steatohepatitis (NASH) and PSC, and inflammatory skin conditions such as psoriasis and atopic dermatitis. DURECT's advanced oral and injectable delivery technologies are designed to enable new indications and enhanced attributes for small-molecule and biologic drugs. One late-stage product candidate in this category is POSIMIR® (SABER®-Bupivacaine), an investigational locally-acting, non-opioid analgesic intended to provide up to 3 days of continuous pain relief after surgery. Another late stage product candidate is REMOXY ER (oxycodone), an investigational pain control drug based on DURECT's ORADUR technology, for which the FDA has set a PDUFA target action date of August 7, 2018. In addition, for the assignment of certain patent rights, DURECT may receive a milestone payment upon NDA approval and single digit sales-based earn-out payments from U.S. net sales of Indivior's RBP-7000 investigational drug for schizophrenia, for which Indivior has submitted an NDA and for which the FDA has set a PDUFA target action date of July 28, 2018. For more information, please visit www.durect.com.

NOTE: POSIMIR®, SABER®, and ORADUR® are trademarks of DURECT Corporation. Other referenced trademarks belong to their respective owners. POSIMIR, DUR-928, RBP-7000 and REMOXY ER are drug candidates under development and have not been approved for commercialization by the U.S. Food and Drug Administration or other health authorities.

DURECT Forward-Looking Statement

The statements in this press release regarding the NDA resubmission of REMOXY ER, the tentative date for the Advisory Committee meeting and the target PDUFA date for REMOXY ER, the potential benefits and uses of DURECT's drug candidates, including the potential use of DUR-928 to treat PSC, NASH and other hepatic and renal diseases, alcoholic hepatitis, acute organ injury or inflammatory skin conditions such as psoriasis and atopic dermatitis, POSIMIR to treat post-surgical pain, REMOXY ER to treat pain, Indivior's RBP-7000 to treat schizophrenia, the potential milestone payments and royalties receivable from Pain Therapeutics, and the potential milestone payment and earn-out payments receivable from Indivior, are forward-looking statements involving risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. Potential risks and uncertainties include, but are not limited to, the risks that the Advisory Committee will cancel the meeting or recommend against approval of the REMOXY ER NDA, that the NDA resubmission of REMOXY ER will not result in product approval by the FDA or will be met with delays, as well as possible adverse events associated with the use of POSIMIR, REMOXY ER and DUR-928, delays and costs due to additional work or other requirements imposed by regulatory agencies for continued development, approval or sale of POSIMIR, REMOXY ER and DUR-928, and the possibility that studies of DUR-928 will not replicate results from earlier clinical trials. Further information regarding risks related to DUR-928, POSIMIR and REMOXY ER and other risks related to DURECT is included in DURECT's Form 10-K filed on March 8, 2018 under the heading "Risk Factors."



Cision View original content:http://www.prnewswire.com/news-releases/durect-announces-fda…

SOURCE DURECT Corporation

Matt Hogan, Chief Financial Officer, DURECT Corporation, 408-777-4936


http://investors.durect.com/phoenix.zhtml?c=121590&p=irol-ne…

[bio-profi]

Heute ist ein wichtiger Tag für Drrx

FDA/Biotech

DURECT Corporation (NASDAQ: DRRX) and Pain Therapeutics, Inc (NASDAQ: PTIE)have FDA AdCom meeting for Remoxy (Durect granted Pain Therapeutics rights to develop/commercialize Remoxy). BZ NOTE: A CRL was issued by the FDA back on September 26, 2016

Eure Einschätzungen?

[Lucky72]

Antwort auf Beitrag Nr.: 58.068.325 von bio-profi am 26.06.18 11:50:53

Diese Woche wird es wieder spannend!

DURECT Corporation (NASDAQ: DRRX)'s schizophrenia treatment candidate RBP-7000, which has been licensed to U.K.-based biotech INDIVIOR PLC/S ADR (OTC: INVVY) has a PDUFA action date of July 28.

https://finance.yahoo.com/news/week-ahead-biotech-conference…

[bio-profi]

Moin zusammen,

Hoffe diesmal kann durect abliefern. Die letzten Beiden Entscheidungen waren leider negativ.

Wie hoch kann’s gehen bei Zulassung?
Wie hoch ist der Markt für das Medikament RBP-7000

Danke und Gruß.

[bio-profi]

Noch was.
Wiesel ist der pdufa Termin am Samstag???

Ist das normal??

[Lucky72]

Antwort auf Beitrag Nr.: 58.285.094 von bio-profi am 24.07.18 09:39:02

Gugst du hier!

Approximately 2.4 million adult Americans suffer from schizophrenia. Long-acting injectables (LAI) have been shown to increase adherence and lower rates of relapse and psychiatric hospitalizations compared with oral therapy. LAI sales to treat schizophrenia were approximately $2.4 billion in 2016.

RBP-7000 is an investigational new drug currently under review by the FDA. It has not been approved for marketing in the U.S. for any indication.

http://www.durect.com/pipeline/development/rbp-7000/" target="_blank" rel="nofollow ugc noopener">
http://www.durect.com/pipeline/development/rbp-7000/

[Lucky72]

Antwort auf Beitrag Nr.: 58.285.094 von bio-profi am 24.07.18 09:39:02

Agreement with Indivior PLC

On September 26, 2017, DURECT entered into a patent purchase agreement whereby DURECT assigned to Indivior UK Limited, an affiliate of Indivior PLC, certain patents that may provide further intellectual property protection for Indivior's RBP‑7000. In consideration for such assignment, Indivior made an upfront non-refundable payment to DURECT of $12.5 million, and also agreed to make an additional $5 million payment to DURECT contingent upon FDA approval of RBP‑7000, as well as quarterly earn-out payments that are based on a single digit percentage of U.S. net sales for certain products covered by the assigned patent rights, including RBP‑7000. The patent rights include granted patents extending through at least 2026.



http://www.durect.com/investors/collaborations/

[bio-profi]

Super!!!
Jetzt muss es nur noch zugelassen werden!!

[Lucky72]

Antwort auf Beitrag Nr.: 58.285.106 von bio-profi am 24.07.18 09:40:15

Normal ist das nicht, aber wahrscheinlich müssen sie wegen Trump am Samstag auch arbeiten!

Vielleicht kommt ja was am Freitag!

[Lucky72]

Die nächsten zwei Wochen bleibt es spannend!

DURECT Corporation Invites You to Join its Second Quarter 2018 Earnings Conference Call

CUPERTINO, Calif., July 24, 2018 /PRNewswire/ -- In conjunction with DURECT Corporation's (Nasdaq: DRRX) second quarter 2018 financial results press release, you are invited to listen to a conference call that will be broadcast live over the internet on Wednesday, August 1, 2018 at 4:30 pm Eastern Time (1:30 pm Pacific Time).

A live audio webcast of the presentation will be available by accessing DURECT's homepage at www.durect.com and clicking "Investor Relations." If you are unable to participate during the live webcast, the call will be archived on DURECT's website under Audio Archive in the "Investor Relations" section.

About DURECT Corporation

DURECT is a biopharmaceutical company actively developing new therapeutics based on its Epigenetic Regulator Program and proprietary drug delivery platforms. DUR-928, a new chemical entity in Phase 2 development, is the lead candidate in DURECT's Epigenetic Regulator Program. An endogenous, orally bioavailable small molecule, DUR-928 has been shown in preclinical studies to play an important regulatory role in lipid homeostasis, inflammation, and cell survival. Human applications may include acute organ injury, hepatic and renal diseases such as nonalcoholic steatohepatitis (NASH) and PSC, and inflammatory skin conditions such as psoriasis and atopic dermatitis. DURECT's advanced oral and injectable delivery technologies are designed to enable new indications and enhanced attributes for small-molecule and biologic drugs. One late-stage product candidate in this category is POSIMIR® (SABER®-Bupivacaine), an investigational locally-acting, non-opioid analgesic intended to provide up to 3 days of continuous pain relief after surgery. Another late stage product candidate is REMOXY® ER (oxycodone), an investigational pain control drug based on DURECT's ORADUR® technology, for which the FDA has set a PDUFA target action date of August 7, 2018. In addition, for the assignment of certain patent rights, DURECT may receive a milestone payment upon NDA approval and single digit sales-based earn-out payments from U.S. net sales of Indivior's RBP-7000 investigational drug for schizophrenia, for which Indivior has submitted an NDA and for which the FDA has set a PDUFA target action date of July 28, 2018. For more information, please visit www.durect.com.

NOTE: POSIMIR®, SABER®, and ORADUR® are trademarks of DURECT Corporation. Other referenced trademarks belong to their respective owners. DUR-928, RBP-7000, REMOXY ER and POSIMIR are drug candidates under development and have not been approved for commercialization by the U.S. Food and Drug Administration or other health authorities.



Cision View original content:http://www.prnewswire.com/news-releases/durect-corporation-i…

SOURCE DURECT Corporation

Matt Hogan, Chief Financial Officer, DURECT Corporation, 408-777-4936


http://investors.durect.com/phoenix.zhtml?c=121590&p=irol-ne…

[Lucky72]

FDA Approves PERSERIS™ (risperidone) for Extended-Release Injectable Suspension for the Treatment of Schizophrenia in Adults
[PR Newswire]
PR NewswireJuly 28, 2018

PERSERIS is the first once-monthly subcutaneous risperidone-containing long-acting injectable

SLOUGH, England and RICHMOND, Va., July 27, 2018 /PRNewswire/ -- Indivior PLC (INDV.L) today announced that the U.S. Food and Drug Administration (FDA) has approved PERSERIS™, the first once-monthly subcutaneous risperidone-containing, long-acting injectable (LAI) for the treatment of schizophrenia in adults. Clinically relevant levels were reached after the first injection of PERSERIS without use of a loading dose or any supplemental oral risperidone.1

"Treatment adherence is a major challenge in schizophrenia due to the complexity of the disease. It is important to have additional treatment options available to physicians to help them improve their patients' symptom severity," said Maurizio Fava, Executive Vice Chair of the Massachusetts General Hospital (MGH) Department of Psychiatry and Indivior clinical research consultant. "The studies carried out by Indivior suggest that PERSERIS may offer patients, caregivers and physicians a new once-monthly subcutaneous medication option to treat adults with schizophrenia."

PERSERIS contains risperidone, a well-established treatment for schizophrenia, and uses the extended-release delivery system to form a subcutaneous (under the skin) depot that provides sustained levels of risperidone over one month. Initial peak risperidone plasma levels occur within 4 to 6 hours of dosing and are due to an initial release of the drug during the depot formation process.1

"Schizophrenia is a devastating, chronic and often disabling mental health condition that impacts the lives of people suffering from this illness, their families and caregivers. The approval of PERSERIS brings us the opportunity to provide adult patients and their healthcare providers with an innovative treatment option that we believe will make a meaningful difference," said Shaun Thaxter, Chief Executive Officer of Indivior. "People with schizophrenia face a complex patient journey that can be hindered by ignorance, apathy and stigma. Indivior is committed to working with stakeholders to reduce the stigma of schizophrenia and expand access to evidence-based treatment."

The efficacy of PERSERIS was evaluated in a pivotal Phase 3 randomized, double-blind, placebo-controlled, 8-week study of 354 patients (NCT 02109562). PERSERIS efficacy was demonstrated by an improvement in the primary clinical endpoint, Positive and Negative Syndrome Scale (PANSS) total score at day 57. The improvement in Clinical Global Impression Severity of Illness (CGI-S) was also statistically significant at day 57. Clinical trials of PERSERIS were designed for the product to be initiated with neither a loading dose nor any supplemental risperidone.1

The safety of PERSERIS was evaluated in 814 adults with schizophrenia who received at least one dose of PERSERIS during clinical trials. A total of 322 patients were treated with PERSERIS for at least six months, with 234 of those treated with PERSERIS for at least 12 months. The systemic safety profile of PERSERIS was consistent with the known safety profile of oral risperidone. The most common systemic adverse reactions in the pivotal Phase 3 trial (in ≥5% of PERSERIS patients and greater than twice placebo) were increased weight, sedation/somnolence and musculoskeletal pain. The most common injection site reactions (≥5% of all patients across PERSERIS and placebo groups) were injection site pain and reddening of the skin.1

The full prescribing information, including BOXED WARNING, for PERSERIS can be found here.

Photos and a multimedia gallery are available at www.IndiviorMedia.com.

https://finance.yahoo.com/news/fda-approves-perseris-risperi…

[Lucky72]

DRRX
DURECT Corporation (DRRX) Nachbörslich Trading - NASDAQ.com
$1.80
*
0.39
+27.66%

*Verzögert - Zum 07/27/2018 19:59



https://www.nasdaq.com/de/symbol/drrx/after-hours

[bio-profi]

Glückwunsch an alle investierten!
Wie weit kann es jetzt kurzfristig gehen. Hoffe, dass wir Montag 2,5 sehen.

Gruß und schönes WE

[Edison09]

Die DURECT Corporation (Nasdaq: DRRX ) hat heute bekannt gegeben, dass Indivior PLC (LON: INDV ) berichtet hat, dass die US-amerikanische Arzneimittelzulassungsbehörde FDA (Food and Drug Administration ) den Zulassungsantrag für PERSERIS ™ (Risperidon) genehmigt hat RBP-7000. Wie von Indivior beschrieben, ist PERSERIS das erste einmal monatlich subkutane Risperidon-haltige, lang wirkende Injektat zur Behandlung von Schizophrenie bei Erwachsenen.

"Wir freuen uns, dass PERSERIS die FDA-Zulassung als innovative Behandlungsoption für Patienten erhält, die unter dem sehr schwierigen medizinischen Krankheitsbild der Schizophrenie leiden", erklärte Jim Brown, President und CEO der DURECT Corporation.

Am 26. September 2017 hat DURECT einen Patent-Kaufvertrag abgeschlossen, in dessen Rahmen DURECT Indivior UK Limited, eine Tochtergesellschaft von Indivior PLC, bestimmte Patente übertragen hat, die PERSERIS weiteren Schutz des geistigen Eigentums bieten können. Als Gegenleistung für diese Abtretung tätigte Indivior eine vorzeitige, nicht rückzahlbare Zahlung an DURECT in Höhe von 12,5 Millionen US-Dollar. Indivior stimmte außerdem zu, weitere Zahlungen in Höhe von 5 Millionen US-Dollar an DURECT zu leisten, abhängig von der NDA-Genehmigung von PERSERIS sowie vierteljährlichen Earn-Out-Zahlungen, die auf einem einstelligen Prozentsatz des US-Nettoumsatzes für bestimmte Produkte basieren, einschließlich der abgetretenen Patentrechte PERS Die Patentrechte umfassen erteilte Patente, die sich mindestens bis 2026 erstrecken.

Weitere Informationen zu PERSERIS finden Sie in den Angaben von Indi

[pharma-trader]

Antwort auf Beitrag Nr.: 58.333.683 von Edison09 am 30.07.18 14:59:57

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