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2023-05-24 08:22:51 ET Sarepta Therapeutics ( NASDAQ: SRPT ) announced Wednesday that the FDA would require additional time to review its marketing application for SRP-9001, a gene therapy targeted at certain patients with Duchenne muscular dystrophy (DMD). The announcement co...
New regulatory action date is June 22, 2023 Sarepta Therapeutics, Inc. (NASDAQ: SRPT), the leader in precision genetic medicine for rare diseases, today provided the following update on the Biologics License Application (BLA) for SRP-9001 (delandistrogene moxeparvovec), which is curre...
2023-05-23 16:21:51 ET Summary SRP-9001’s pivotal trial surrogate endpoint was highly statistically significant. The FDA’s Advisory Committee voted 8-6 on May 12 in support of Accelerated Approval. SRP-9001 will likely earn marketing authorization on May 29. ...
2023-05-21 12:00:17 ET Developers have increasingly relied on an FDA shortcut to win accelerated drug approvals while their confirmatory trials got delayed at the expense of billions to the government-backed healthcare system, a recent analysis from Bloomberg News indicates. The...
2023-05-16 15:42:00 ET Biotech stocks have been on a wild ride this year. For instance, the bellwhether SPDR S&P Biotech ETF (NYSEMKT: XBI) has been up by as much as 9%, and down by as much as 12%, during just the first five months of 2023. Today, this extreme volatility among ...
2023-05-16 15:07:49 ET Summary Last week, an FDA advisory committee voted in favor of approving Sarepta Therapeutics, Inc.'s SRP-9001 for treating DMD. Sarepta Therapeutics stock has good near-term momentum as the BLA is scheduled for May 29. Sarepta Therapeutics, Inc. is also...
Sarepta Therapeutics, Inc. (NASDAQ: SRPT) is one of today's top gainers. The company's shares are currently up 27.97% on the day to $153.82. Sarepta Therapeutics, Inc., a commercial-stage biopharmaceutical company, focuses on the discovery and development of RNA-targeted therapeutics, gene the...
2023-05-15 10:59:17 ET Shares of Sarepta Therapeutics (NASDAQ: SRPT) were skyrocketing 24.9% higher as of 10:37 a.m. ET on Monday. The huge gain came after the company announced Friday evening that a U.S. Food and Drug Administration (FDA) advisory committee voted in support of acce...
2023-05-15 07:55:16 ET Following a trading halt on Friday, Sarepta Therapeutics ( NASDAQ: SRPT ) climbed ~29% in the pre-market as Wall Street reacted to a favorable decision by an FDA advisory committee last week over the company’s marketing application for gene therapy ...
– Advisory committee voted 8-6 in support of accelerated approval of SRP-9001 – Regulatory action date is May 29, 2023 Sarepta Therapeutics, Inc. (NASDAQ: SRPT), the leader in precision genetic medicine for rare diseases, today announced that the U.S. Foo...
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Rick Barry appointed Executive Chairman of the Board Remi Barbier resigns as President and CEO and from the Board of Directors Cassava initiates search for a new CEO AUSTIN, Texas, July 17, 2024 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA) today announced that the Boa...
2024-07-08 12:10:00 ET Stock Traders Daily has produced this trading report using a proprietary method. This methodology seeks to optimize the entry and exit levels to maximize results and limit risk, and it is also applied to Index options, ETFs, and futures for our subscribers. This...