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August 7, 2014
06:48 EDTPTCTPTC Therapeutics files automatic mixed securities shelf
News For PTCT From The Last 14 Days
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September 30, 2015
08:04 EDTPTCTPTC Therapeutics submits European applicatoin for Translama
PTC Therapeutics announced that the European Medicines Agency has validated the submission of a variation for a new indication for Translarna for the treatment of nonsense mutation cystic fibrosis for patients not taking chronic inhaled aminoglycoside antibiotics. If approved, Translarna would be the first oral protein restoration treatment that targets the underlying cause of nmCF. Approximately 10% of cystic fibrosis patients have their disease as a result of a nonsense mutation, which can cause the most severe form of cystic fibrosis. Translarna received marketing authorization in the European Economic Area in July 2014 for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD) in ambulatory patients aged five years and older. The regulatory application for Translarna for nmCF is based on previously announced analyses from the company's prior completed Phase 3 double-blind, placebo-controlled study comparing Translarna to placebo in nmCF patients. PTC is conducting an additional randomized, double-blind, placebo-controlled Phase 3 study of Translarna in nmCF patients and expects enrollment to be completed by the end of this year, with top-line data expected by the end of 2016.
September 25, 2015
12:38 EDTPTCTOptions with increasing implied volatility
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September 24, 2015
11:08 EDTPTCTOptions with increasing implied volatility
Options with increasing implied volatility: PTCT CZR KITE HZNP NAV CREE VRX PNK
September 23, 2015
10:24 EDTPTCTOptions with increasing implied volatility
Options with increasing implied volatility: SNCR PTCT SRPT AMZN CREE CMG ISRG QLIK SNKD BIIB JNPR
September 22, 2015
10:23 EDTPTCTOptions with increasing implied volatility
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06:19 EDTPTCTClinton to roll out plan to rein in prescription drug costs, USA Today reports
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September 21, 2015
14:04 EDTPTCTClinton vow to end drug price gouging sinks biotechs
Biotech stocks have declined across the board in afternoon trading following a tweet by Presidential candidate Hillary Clinton criticizing the "outrageous" prices of specialty drugs. TURING STEPS UP PRICING: Clinton's tweet directly referenced Turing Pharmaceuticals' Daraprim treatment for toxoplasmosis, which recently had its price hiked from just $13.50 per pill to $750 after the privately-held company acquired the drug from Impax Laboratories (IPXL). Importantly, Daraprim was first approved by the FDA in 1953 and its patents have long since expired. No generic versions of the drug currently exist, perhaps in part due to Turing executive chairman Martin Shkreli's strategy of tightly controlling distribution, according to a New York Post article on the issue. In a Bloomberg TV interview this morning, Shkreli claimed that the drug remains underpriced compared to what he called its peers in the rare disease space. However, note that a World Health Organization analysis from 2013 reported that over 190,000 cases of toxoplasmosis occur globally every year and Daraprim continues to be listed on the organization's list of essential medicines for a basic health-care system. INDUSTRY CRITICISM: Turing's Daraprim pricing prompted a response from the Infectious Diseases Society of America and the HIV Medicine Association, which criticized the "unjustifiable" new cost of the drug and urged a "rational" pricing strategy. The news surrounding Daraprim also comes on the heels of Presidential candidate Bernie Sanders issuing a letter in August to Valeant (VRX) and Hospira (HSP), in which he requested information on the "enormous" price increases of two drugs Valeant acquired earlier in the year. REPUBLICAN CONGRESS: In a research note released this afternoon, RBC Capital analyst Michael Yee reminded investors that Republicans still control Congress, offering a sobering reminder that campaign trail promises often fall by the wayside once the candidate steps into office. Yee explained that, though drug pricing debates during next year's election will probably generate headline risk for the biotech space, the Republican-controlled Congress is unlikely to sign into law any material changes on the issue. BIOTECH STOCK ACTION: Hillary Clinton's promise to "lay out a plan" tomorrow to tackle "price gouging" in the specialty drug market sent numerous biotech stocks plunging. Aerie Pharmaceuticals (AERI) has crashed 12.6% at time of writing, while Retrophin (RTRX), Ultragenyx (RARE), and PTC Therapeutics (PTCT) are down 14.7%, 13.4%, and 11%, respectively. Biotech giants AbbVie (ABBV), Gilead (GILD), Bristol-Myers Squibb (BMY) and Biogen (BIIB) have also slipped in intraday trading, while the NASDAQ Biotechnology index is down roughly 4%.
13:17 EDTPTCTRBC reminds biotech investors that Republicans still control Congress
RBC Capital analyst Michael Yee notes that biotech indices are under pressure after Hillary Clinton tweeted about an upcoming plan to fight specialty drug pricing. The news follows a Wall Street Journal story about a private company dramatically increasing the price of their drug and another confirmed progressive multifocal leukoencephalopathy case for Biogen (BIIB), Yee tells investors in an intraday research note. Next year's election is likely to turn up the noise around drug pricing, creating headline risk for the biotech space, the analyst cautions. However, he reminds investors that Republicans control Congress, making it unlikely that "anything material" will get signed into law. Biotech names moving lower in today's trading include Biogen, AbbVie (ABBV), Gilead (GILD), Alkermes (ALKS), BioMarin (BMRN), Amicus (FOLD) and PTC Therapeutics (PTCT).

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