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News Breaks
August 4, 2014
09:32 EDTPTCTPTC Therapeutics announces conditional EU approval of Translarna
PTC Therapeutics announced that the European Commission has granted conditional marketing authorization for Translarna, in the European Union for the treatment of nonsense mutation Duchenne muscular dystrophy in ambulatory patients aged five years and older. The authorization allows PTC to market Translarna in the 28 countries that are Member States of the European Union, as well as European Economic Area members Iceland, Liechtenstein and Norway. As part of the conditional marketing authorization, PTC is obligated to complete its confirmatory Phase 3 trial in nmDMD and submit additional efficacy and safety data from the trial.
News For PTCT From The Last 14 Days
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August 28, 2015
11:04 EDTPTCTOptions with increasing implied volatility
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August 27, 2015
10:57 EDTPTCTOptions with increasing implied volatility
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August 26, 2015
10:36 EDTPTCTOptions with increasing implied volatility
Options with increasing implied volatility: UVXY PTCT VIX SVXY SUNE SQQQ SPXS LPI
August 25, 2015
09:59 EDTPTCTOn The Fly: Analyst Initiation Summary
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08:01 EDTPTCTPTC Therapeutics initiated with a Buy at Citi
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August 24, 2015
15:44 EDTPTCTOptions with increasing implied volatility
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10:12 EDTPTCTOptions with increasing implied volatility
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August 21, 2015
10:36 EDTPTCTOptions with increasing implied volatility
Options with increasing implied volatility: PTCT UVXY VIX VXX SVXXY SRPT TZA UPRO VNR SPXU
August 19, 2015
09:17 EDTPTCT'Female Viagra' approval seen as positive for Sarepta, BioMarin
The FDA's approval of the world's first drug designed to boost a woman's sexual desire is seen as boding well for companies awaiting critical decisions by the agency. FEMALE VIAGRA: The Food and Drug Administration yesterday approved flibanserin to treat acquired, generalized hypoactive sexual desire disorder in premenopausal women. The drug, which will be sold under the name "Addyi" and is commonly referred to as the "female Viagra," is the first FDA-approved treatment for sexual desire disorders in men or women, the agency prominently stated in its press release. HSDD is characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to a co-existing medical or psychiatric condition, problems within the relationship, or the effects of a medication or other drug substance, the FDA explained. Addyi was approved with a risk evaluation and mitigation strategy as well as a Boxed Warning given the risk of severe hypotension and syncope in patients who drink alcohol during treatment. The drug is made by privately held Sprout Pharmaceuticals. ANALYST REACTION: Addyi's approval is "another sign of flexibility" by the FDA, especially for first-in-class therapies, Roth Capital analyst Debjit Chattopadhyay writes this morning in a note to investors. This bodes well for the approval of eteplirsen, drisapersen and Translarna, the analyst contends. Eteplirsen, designed by Sarepta Therapeutics (SRPT), and drisapersen, designed by BioMarin (BMRN), are experimental drugs being developed to treat Duchenne muscular dystrophy. Translarna, designed by PTC Therapeutics (PTCT), is already being sold in Europe as a treatment for DMD and is awaiting approval from the FDA. Duchenne muscular dystrophy is a form of muscular dystrophy affecting around 1 in 3,600 boys, which results in muscle degeneration and premature death. SAVING LIVES: While female sexual dysfunction is a clinical problem, eteplirsen is designed to save lives, Chattopadhyay points out. He has a Buy rating on Sarepta and noted his price target of $45 assumes accelerated approval for eteplirsen in the first quarter of 2016. Shares of the Massachusetts-based biopharmaceutical company closed yesterday at $35.69.
08:29 EDTPTCTFlibanserin approval bodes well for Sarepta, others, says Roth Capital
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