Prosensa Holding N.V. (RNA) announced that it has initiated the process of rolling submission of a new drug application (NDA) to the FDA for its lead candidate, drisapersen, for the treatment of Duchenne muscular dystrophy (DMD). Drisapersen has Breakthrough Therapy Designation in the U.S. Moreover, the fast track status for drisapersen has made Prosensa eligible for making a rolling NDA submission for the candidate. According … Continue reading Biotech Stock News: Prosensa Starts Rolling NDA Submission, Stock Reacts

Alnylam Pharmaceuticals, Inc (ALNY) revealed encouraging initial results from an ongoing phase II open-label extension study (n=27) on one of its most important pipeline candidates, patisiran (ALN-TTR02). The stock soared almost 19% following the announcement. Patisiran, one of the most advanced candidates at Alnylam, is a subcutaneously administrated ribo nucleic acid interference (RNAi) therapeutic being developed for the treatment of transthyretin (TTR)-mediated amyloidosis (ATTR) in … Continue reading Biotech Stock News: Alnylam Jumps on Positive Patisiran Data

Investors in the pharma/biotech sector eagerly wait for pipeline updates as they play an important role in deciding whether or not to invest in a particular company. These updates provide information on experimental drugs and at times give an insight into the commercial potential of the candidate once it is successfully developed and commercialized. Late last week, Amgen (AMGN) provided an update on its cancer … Continue reading Biotech Stock News: Amgen’s Blinatumomab Gets Priority Review

Amgen Inc (AMGN) was up almost 3% on encouraging top-line data from a phase III study on its biosimilar candidate, ABP 501. The randomized, double-blind, active-controlled study compared the safety and efficacy of ABP 501 to AbbVie Inc’s (ABBV) Humira in adults suffering from moderate-to-severe plaque psoriasis. The study met its primary endpoint of Psoriasis Area and Severity Index (PASI) percent improvement from baseline at … Continue reading Biotech Stocks: Amgen Up Due To Positive Phase III Data

Endo International (ENDP) is set to acquire Auxilium Pharmaceuticals, Inc (AUXL) for $2.6 billion ($33.25 per share) in cash as well as stock. The transaction is expected to close by the first half of 2015. The acquisition is expected to be immediately accretive to Endo’s earnings following the closure. Auxilium Pharma grabbed Endo’s offer, which represented a huge premium of 55% over Auxilium Pharma’s Sep … Continue reading Biotech Stock in News: Endo to Buy Auxilium & Diversify Portfolio

Good news flowed in at Gilead Sciences (GILD) with the FDA approving the company’s Harvoni for treating patients affected with chronic hepatitis C virus (HCV) genotype 1 infection. Harvoni is a once-daily combination treatment of Gilead’s highly successful HCV drug Sovaldi (sofosbuvir 400 mg) and ledipasvir (a NS5A inhibitor 90 mg). Following the FDA approval, Harvoni becomes the first single tablet regimen to treat HCV … Continue reading Biotech Stock News: Gilead Inc Gets Another Major Boost