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Fly News Breaks for August 20, 2019
SRPT
Aug 20, 2019 | 08:49 EDT
After Sarepta Therapeutics announced it had received a complete response letter from the FDA for its new drug application for golodirsen, William Blair analyst Tim Lugo said he still sees significant value in Sarepta's pipeline despite the CRL setback, which he said "can only be described as odd." The FDA's reasons for the CRL include the generic risk of infection at the site of IV infusion ports and a theoretical renal toxicity, which was only observed in preclinical models at doses that were ten-fold higher than the dose used in studies, noted Lugo, who added that he "cannot help but feel there is more to the CRL than the issues cited in the release." He keeps an Outperform rating on Sarepta shares, citing his belief that golodirsen and casimersen will ultimately receive FDA approval as well as the company's lead position in microdystrophin gene therapy.
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