- Published: 08 September 2017
- Written by Investor Ideas
September 7, 2017 – Investorideas.com, a global news source and investor resource covering cannabis and biotech stocks issues a sector snapshot for the biotech sector as Insmed Incorporated (Nasdaq:INSM) sees massive gains this week on news of ‘PositiveTop-Line Results from Phase 3 CONVERT Study of ALIS (Amikacin Liposome Inhalation Suspension) in Adult Patients with Treatment-Refractory Nontuberculous Mycobacterial (NTM) Lung Disease Caused by Mycobacterium Avium Complex (MAC)’.
Read this news in full at http://www.investorideas.com/news/2017/biotech/09071Stocks.asp
According to an analyst at Zacksthis Tuesday, "Biotech stocks were once a strong favorite chalking up impressive gains until 2015 when the drug pricing issue started weighing on the sector. But the sector rebounded in 2017 and is on a roll since the beginning of the year with the industry gaining 15.9% year to date, outperforming the broader market which is up 10.7%.”
https://finance.yahoo.com/news/biotech-stocks-back-favor-rally-120012983.html
On Tuesday, September 5th, Insmed Incorporated (NASDAQ:INSM), a global biopharmaceutical company focused on the unmet needs of patients with rare diseases, announced top-line data from its Phase 3 CONVERT study.
Top-Line Efficacy Data
The global CONVERT study met its primary endpoint of culture conversion by Month 6 with statistical and clinical significance. The study demonstrated that the addition of ALIS to guideline-based therapy (GBT) eliminated evidence of NTM lung disease caused by MAC in sputum by Month 6 in 29% of patients, compared to 9% of patients on GBT alone (p <0.0001). The trial was powered to detect a treatment effect of 15% between the two treatment groups. The CONVERT study enrolled 336 adult patients with NTM lung disease caused by MAC who were refractory to at least six months of GBT. Patients were randomized 2:1 to receive ALIS plus GBT versus GBT alone. The primary endpoint was the proportion of patients achieving culture conversion by Month 6.
Insmed plans to pursue accelerated approval of ALIS under subpart H based on the data from the CONVERT study, which will be reviewed by the Division of Anti-Infective Products. FDA previously granted this product breakthrough therapy designation and fast track status and designated ALIS as a qualified infectious disease product (QIDP) under the Generating Antibiotic Incentives Now (GAIN) Act.
Scythian Biosciences Corp. (TSX.V: SCYB.V)(http://scythianbio.com/), a research and development company committed to finding a solution for the prevention and treatment of concussions and traumatic brain injury with its proprietary Cannabinoid combination, announced on Tuesday, September 5th that Maghsoud Dariani had become the Chief Scientific Officer of the Company. Mr. Dariani was previously on the Company's advisory board and has over 35 years of experience in the development and commercialization of products in the pharmaceutical industry. Mr. Dariani's experience includes, among other things, management positions at Semorex, Focus Pharmaceuticals, Celgene (NASDAQ:CELG), and Chiral Pharmaceuticals.
Scythian Biosciences Corp.(TSX.V: SCYB.V)also announced on August 30th that it had submitted an initial listing application to list its common shares on the NASDAQ Capital Market
Celgene Corporation (Nasdaq:CELG), a global biopharmaceutical company engaged in the discovery, development and commercialization of innovative therapies for the treatment of cancer and immune-inflammatory related diseases, recently announced that it will visit the Nasdaq MarketSite in Times Square. Mark Alles, Chief Executive Officer will ring the Opening Bell on Thursday, September 7th, 2017 - 9:15 AM to 9:30 AM ET.
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