Sarepta Elevidys accelerated approval criticized by ICER exec [Seeking Alpha]
Sarepta Therapeutics, Inc. (SRPT)
Last sarepta therapeutics, inc. earnings: 2/26 04:05 pm
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Source: Seeking Alpha
of Sarepta Therapeutics' ( NASDAQ: SRPT ) Duchenne muscular dystrophy treatment Elevidys (delandistrogene moxeparvovec) as an example. In a viewpoint for JAMA , Institute for Clinical and Economic Review Chief Medical Officer David Rind wrote that Elevidys was approved even though the therapy missed its primary endpoint in two trials. The approval in June 2023 was based on a surrogate endpoint. The surrogate endpoint Sarepta used was to measure levels microdystrophin, a gene that is negatively impacted by the disease. Although the company posited that higher levels of microdystrophin point to a clinical benefit, Rind argues there's no data to support that idea. Elevidys comes with a $3.2M price tag, another issue for Rind. "This is an enormous price tag for a therapy that has failed to meet its primary end point in the 2 randomized trials in which it has been studied and that is clearly not curative." An FDA advisory committee in May 2023 voted the benefits of the treatment ou
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News
- Roblox downgraded, Western Digital initiated: Wall Street's top analyst calls [Yahoo! Finance]Yahoo! Finance
- Sarepta Therapeutics, Inc. (NASDAQ: SRPT) was upgraded by analysts at Oppenheimer Holdings Inc. from a "market perform" rating to an "outperform" rating. They now have a $180.00 price target on the stock.MarketBeat
- Earnings Beat: Sarepta Therapeutics, Inc. Just Beat Analyst Forecasts, And Analysts Have Been Updating Their Models [Yahoo! Finance]Yahoo! Finance
- Sarepta Therapeutics, Inc. (NASDAQ: SRPT) had its price target lowered by analysts at JPMorgan Chase & Co. from $177.00 to $175.00. They now have an "overweight" rating on the stock.MarketBeat
- Gene Therapy Pioneer Jerry R. Mendell, M.D., Named to Inaugural TIME100 Health List of the 100 Most Influential People in Global Health [Yahoo! Finance]Yahoo! Finance
SRPT
Earnings
- 5/1/24 - Beat
SRPT
Sec Filings
- 5/6/24 - Form 4
- 5/6/24 - Form 3
- 5/1/24 - Form 10-Q
- SRPT's page on the SEC website