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New Aetna Clinical Policy Bulletin Details 'Medical Necessity' Of Sarepta's Exondys 51
Friday, December 2, 2016 - 12:33pm | 333After agreeing to cover Sarepta Therapeutics Inc (NASDAQ: SRPT)’s controversial Duchenne muscular dystrophy drug Exondys 51, insurer Aetna Inc (NYSE: AET) has released a new clinical policy bulletin describing the conditions under which it deems the drug medically necessary. Aetna now...
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Aetna Still Undecided On Coverage For Sarepta's Highly Debated Muscular Dystrophy Treatment
Monday, November 21, 2016 - 3:19pm | 607Back on October 6, Duchenne Muscular Dystrophy (DMD) treatment advocate Jenn McNary announced on Twitter that Humana Inc (NYSE: HUM) had approved 100 percent coverage for a patient wanting access to Sarepta Therapeutics Inc (NASDAQ: SRPT) muscular dystrophy drug eteplirsen - marketed as EXONDYS...
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A Timeline Of PTC Therapeutics' Translarna Journey
Friday, November 11, 2016 - 12:58pm | 430Shares of PTC Therapeutics, Inc. (NASDAQ: PTCT) soared more than 80 percent higher on Friday. The company confirmed that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the renewal of the company's therapy called Translarna (ataluren...
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3 Reasons 2017 Launch Expectations For Sarepta's EXONDYS 51 Are 'Too High'
Friday, November 11, 2016 - 11:30am | 365Leerink's Joseph Schwartz felt it prudent to take a deep dive into Sarepta Therapeutics Inc's (NASDAQ: SRPT) EXONDYS 51, the company's therapy for the treatment of Duchenne muscular dystrophy (DMD). There are three reasons investors should take a "more cautious view" on...
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PTC Therapeutics Surges 88% On European Marketing Authorization
Friday, November 11, 2016 - 9:46am | 362Shares of PTC Therapeutics, Inc. (NASDAQ: PTCT) soared higher by nearly 90 percent early Friday morning after the company announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the renewal of the company's therapy called...
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Sarepta Shares Fall After Anthem Blue Cross Finds Issue With Eteplirsen
Friday, October 7, 2016 - 11:23am | 356Shares of Sarepta Therapeutics Inc (NASDAQ: SRPT) fell about 5 percent Friday after Anthem Blue Cross said the clinical benefit of treatment for DMD (Duchenne Muscular Dystrophy) with the company's eteplirsen (Exondys 51), including improved motor function, has "not been demonstrated....
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DMD Deal With Summit Is 'Low Risk, High Reward' For Sarepta
Tuesday, October 4, 2016 - 11:00am | 295Sarepta Therapeutics Inc (NASDAQ: SRPT) forged a deal with Summit Therapeutics PLC (ADR) (NASDAQ: SMMT) to develop its utrophin pipeline in exchange for European rights and a Latin America option. Summit's stock soared higher by more than 100 percent following the announcement, but analysts...
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Sarepta Wins Exclusive License, Collaboration Deal for European Rights To Summit's DMD Drug
Tuesday, October 4, 2016 - 8:37am | 302Sarepta Therapeutics Inc (NASDAQ: SRPT) and Summit Therapeutics plc (NASDAQ: SMMT) reached an exclusive license and collaboration agreement. As a result, Sarepta has been granted rights in Europe, and Turkey apart from the Commonwealth of Independent States to Summit's utrophin modulator...
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Sarepta Dosing First Patients In Phase 3 Trial Of Duchenne Muscular Dystrophy Drug
Thursday, September 29, 2016 - 7:31am | 216Sarepta Therapeutics Inc (NASDAQ: SRPT) revealed that it dosed first patient in final stage clinical study of SRP-4045 and SRP-4053 for treatment of Duchenne Muscular Dystrophy Amenable to exon 45 or 53 skipping. The company indicated the third stage trial, ESSENCE, is a double-blind, placebo-...
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FDA Commish Says Sarepta's DMD Study Should Be Retracted
Thursday, September 22, 2016 - 10:24am | 333It looks like Sarepta Therapeutics Inc (NASDAQ: SRPT)'s Eteplirsen may not be out of the woods just yet. A letter from U.S. Food & Drug Administration Commissioner Robert Califf is calling for the drug's latest study to be retracted. The 13-page memo is dated Friday,...
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Sarepta Prices Newly-Approved DMD Drug, Cowen Upgrades Stock To Outperform
Tuesday, September 20, 2016 - 11:24am | 300Sarepta Therapeutics Inc (NASDAQ: SRPT) hosted a conference call Tuesday to discuss its newly approved drug, Exondys 51 (eteplirsen) injection, which happens to be the first drug approved to treat patients with Duchenne muscular dystrophy (DMD). Sarepta said Exondys 51 will be available in a...
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Sarepta Analysts Turn Bullish After Duchenne Muscular Dystrophy Drug Eteplirsen Gets Approval
Monday, September 19, 2016 - 2:27pm | 335Shares of Sarepta Therapeutics Inc (NASDAQ: SRPT) soared higher by more than 80 percent Monday and hit a new 52-week high of $56.18. Traders turned uber-bullish on the stock after the U.S. Food and Drug Administration granted an accelerated approval for its Duchenne Muscular Dystrophy (DMD) drug...
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PTC Therapeutics Gets Big Boost From Sarepta's DMD Drug Approval
Monday, September 19, 2016 - 12:32pm | 289PTC Therapeutics, Inc. (NASDAQ: PTCT) shares received a big boost Monday, thanks to positive tidings received by Sarepta Therapeutics Inc. (NASDAQ: SRPT). The latter received FDA's accelerated approval for eteplirsen for treating exon 51 skipping amenable Duchenne's muscular dystrophy....
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Sarepta Spikes 20%, Feuerstein Says Company Can Win FDA Drug Approval
Thursday, April 28, 2016 - 11:15am | 278Shares of Sarepta Therapeutics Inc (NASDAQ: SRPT) spiked higher by around 20 percent Thursday morning after The Street's biotech expert Adam Feuerstein penned an article titled "Why Sarepta Can Ultimately Win FDA Drug Approval." Shares of Sarepta were hard hit after a federal...
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Sarepta Therapeutics Dropped 10% Following FDA News
Monday, February 8, 2016 - 2:01pm | 209Shares of Sarepta Therapeutics Inc (NASDAQ: SRPT) plunged more than 10 percent on Monday and hit a new 52-week low of $10.60 after the company received a notification from the U.S. Food and Drug Administration. The FDA told Sarepta Therapeutics that it requires additional time to complete its...