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Fly News Breaks for January 22, 2020
Jan 22, 2020 | 10:25 EDT
RBC Capital analyst Brian Abrahams says the just released Complete Response Letter that the FDA sent to Sarepta Therapeutics last year corroborates with management's messaging. The CRL confirms the company's prior statements that the reviewer had two primary issues, the risk of infections, and potential for renal toxicity, Abrahams tells investors in a research note. The analyst says that given Sarepta's ability to "quickly and successfully" navigate the appeal process and bring Vyondys to the market, and the ongoing reorganization of the neurology drug review division at the FDA, he continues to believe the company will be able to work with regulators to gain approval for casimersen in the near term and microdystrophin gene therapy in the 2021 time-frame. Abrahams remains bullish on Sarepta shares with an Outperform rating. The stock in morning trading is down 1% to $121.38.
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