(SUPN) 2 FDA Zulassungen (Juli & Oktober) 100-200% Potential !!! (Seite 2)
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ISIN: US8684591089 · WKN: A1JX3U · Symbol: SUPN
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Supernus Announces that its Partner Shire Receives FDA Approval for Mydayis™ for ADHD
Wed June 21, 2017 12:37 PM|GlobeNewswire|About: SUPN
ROCKVILLE, Md., June 21, 2017 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (NASDAQ:SUPN), a specialty pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved MydayisTM (mixed salts of a single-entity amphetamine product), a once-daily treatment comprised of three different types of drug-releasing beads for patients 13 years and older with Attention Deficit Hyperactivity Disorder (ADHD). Mydayis is not for use in children 12 years and younger. Shire expects to make Mydayis commercially available in the United States in the third quarter of 2017.
Mydayis was originally developed by Shire Laboratories, the former division of Shire that subsequently became Supernus Pharmaceuticals. Based on the agreement between Supernus and Shire, Shire will pay to Supernus a single digit percentage royalty on net sales of the product.
“We believe Mydayis clinical profile represents a novel treatment for ADHD patients. Having shown efficacy lasting up to 16 hours after taking one capsule, beginning at 2 or 4 hours post-dose, this novel product should prove to be an important option treatment for many patients 13 years and older,” said Jack Khattar, President and CEO of Supernus Pharmaceuticals.
For full prescribing and safety information on Mydayis, refer to Shire’s press release dated June 20, 2017.
https://seekingalpha.com/pr/16868587-supernus-announces-part…
Der Wert hat sich schön entwickelt und es sollte noch weiter gehen.
Gruß
Oberländler
Wed June 21, 2017 12:37 PM|GlobeNewswire|About: SUPN
ROCKVILLE, Md., June 21, 2017 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (NASDAQ:SUPN), a specialty pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved MydayisTM (mixed salts of a single-entity amphetamine product), a once-daily treatment comprised of three different types of drug-releasing beads for patients 13 years and older with Attention Deficit Hyperactivity Disorder (ADHD). Mydayis is not for use in children 12 years and younger. Shire expects to make Mydayis commercially available in the United States in the third quarter of 2017.
Mydayis was originally developed by Shire Laboratories, the former division of Shire that subsequently became Supernus Pharmaceuticals. Based on the agreement between Supernus and Shire, Shire will pay to Supernus a single digit percentage royalty on net sales of the product.
“We believe Mydayis clinical profile represents a novel treatment for ADHD patients. Having shown efficacy lasting up to 16 hours after taking one capsule, beginning at 2 or 4 hours post-dose, this novel product should prove to be an important option treatment for many patients 13 years and older,” said Jack Khattar, President and CEO of Supernus Pharmaceuticals.
For full prescribing and safety information on Mydayis, refer to Shire’s press release dated June 20, 2017.
https://seekingalpha.com/pr/16868587-supernus-announces-part…
Der Wert hat sich schön entwickelt und es sollte noch weiter gehen.
Gruß
Oberländler
Supernus Pharmaceuticals beats by $0.01, beats on revenue
Feb. 28, 2017 11:16 PM ET|About: Supernus Pharmaceuticals,... (SUPN)|By: Jignesh Mehta, SA News Editor
•Supernus Pharmaceuticals (NASDAQ:SUPN): Q4 EPS of $0.26 beats by $0.01.
•Revenue of $61.1M (+43.2% Y/Y) beats by $1.59M.
http://seekingalpha.com/pr/16757034-supernus-announces-recor…
Sieht gut aus.
Gruß Oberländler
Feb. 28, 2017 11:16 PM ET|About: Supernus Pharmaceuticals,... (SUPN)|By: Jignesh Mehta, SA News Editor
•Supernus Pharmaceuticals (NASDAQ:SUPN): Q4 EPS of $0.26 beats by $0.01.
•Revenue of $61.1M (+43.2% Y/Y) beats by $1.59M.
http://seekingalpha.com/pr/16757034-supernus-announces-recor…
Sieht gut aus.
Gruß Oberländler
Meiner Meinung nach immer noch interessant:
Supernus Announces Positive Results from Phase IIb Clinical Trial For SPN-812 in Children with ADHD
Tue October 11, 2016 7:45 AM|GlobeNewswire | About: SUPN
• Study confirms efficacy and tolerability of SPN-812, a novel non-stimulant product, in children with ADHD
• Study meets primary endpoint with statistically significant reduction in ADHD symptoms
•Conference call and webcast to discuss results at 9:00 a.m. ET, October 11, 2016
http://seekingalpha.com/pr/16629620-supernus-announces-posit…
Gruß Oberländler
Supernus Announces Positive Results from Phase IIb Clinical Trial For SPN-812 in Children with ADHD
Tue October 11, 2016 7:45 AM|GlobeNewswire | About: SUPN
• Study confirms efficacy and tolerability of SPN-812, a novel non-stimulant product, in children with ADHD
• Study meets primary endpoint with statistically significant reduction in ADHD symptoms
•Conference call and webcast to discuss results at 9:00 a.m. ET, October 11, 2016
http://seekingalpha.com/pr/16629620-supernus-announces-posit…
Gruß Oberländler
Der Thread wurde für weiteren Austausch wieder aktiviert, viel Spaß bei der Diskussion
Die zweite Zulassung steht kurz bevor ...
The NDA for SPN-804 is currently under review by the FDA with a PDUFA date of October 19, 2012.
The NDA for SPN-804 is currently under review by the FDA with a PDUFA date of October 19, 2012.
glückwunsch...
Über 100% in Plus ....
http://finance.yahoo.com/q?s=supn&ql=1
http://finance.yahoo.com/q?s=supn&ql=1
Gute Nachrichten von der FDA aktie explodiert in der Vorbörse .
http://finance.yahoo.com/news/supernus-receives-tentative-ap…
http://finance.yahoo.com/news/supernus-receives-tentative-ap…
Diese kaum bekannte Perle ist erst seit kurzem an der Nasdaq gelistet .
2x FDA zulassungen(juli und oktober) stehen an ,beide Medikamente sind für die behandlung von Epilepsie und haben RIESIGES Potential .
Mir persönlich gefällt hauptsächlich das sehr geringe low float von nur 4,9 Mil Aktien, das für heftige kurssprünge verantwortlich ist .
Mehr Infos später ...
Supernus Pharma (SUPN)
Marktkap : 144 Mil $
Cash : 50 Mil $
Kurs : 6.05 $
Low float : 4,9 Mil
Insider
http://www.secform4.com/insider-trading/1356576.htm
Blockbuster Pipeline
http://www.supernus.com/products.aspx
Our two epilepsy product candidates are SPN-538 (extended release topiramate), for which we submitted a new drug application, or NDA, that was accepted for filing by the U.S. Food and Drug Administration, or the FDA, in November 2011, and SPN-804 (extended release oxcarbazepine) for which we submitted an NDA that was accepted for filing by the FDA in February 2012. The Prescription Drug User Fee Act, or PDUFA, date for SPN-538 is in July 2012. The PDUFA date for SPN-804 is in October 2012.
2x FDA zulassungen(juli und oktober) stehen an ,beide Medikamente sind für die behandlung von Epilepsie und haben RIESIGES Potential .
Mir persönlich gefällt hauptsächlich das sehr geringe low float von nur 4,9 Mil Aktien, das für heftige kurssprünge verantwortlich ist .
Mehr Infos später ...
Supernus Pharma (SUPN)
Marktkap : 144 Mil $
Cash : 50 Mil $
Kurs : 6.05 $
Low float : 4,9 Mil
Insider
http://www.secform4.com/insider-trading/1356576.htm
Blockbuster Pipeline
http://www.supernus.com/products.aspx
Our two epilepsy product candidates are SPN-538 (extended release topiramate), for which we submitted a new drug application, or NDA, that was accepted for filing by the U.S. Food and Drug Administration, or the FDA, in November 2011, and SPN-804 (extended release oxcarbazepine) for which we submitted an NDA that was accepted for filing by the FDA in February 2012. The Prescription Drug User Fee Act, or PDUFA, date for SPN-538 is in July 2012. The PDUFA date for SPN-804 is in October 2012.
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