- Earlier today, an article was published by Stat News noting that reviewers at the FDA were leaning toward rejecting Sarepta Therapeutics Inc's SRPT closely watched gene therapy for Duchenne muscular dystrophy.
- Peter Marks, a top FDA official, stepped in and directed staff to schedule an advisory committee meeting on the therapy on May 12.
- William Blair writes that the article detailed internal debates at the FDA regarding the accelerated approval for Sarepta's SRP-9001.
- The analyst says that while the article suggests the FDA was leaning toward non-approval, it also does not reflect the current status that an AdCom has been scheduled, that the FDA official most concerned with approval is no longer at the agency.
- Senior officials at the agency are looking to outside validation for approval.
- Weakness around the article should be viewed as a buying opportunity.
- William Blair maintains Outperform rating on the stock with a fair value estimate of $176 per share.
- Mizuho analyst says the article about the behind the scene events at the FDA introduces greater risk relative to the prevalent thinking that the BLA will likely receive accelerated approval.
- However, the article also supports Sarepta's argument that the head of the FDA's biologic center (CBER) would like to see the BLA approved under the accelerated pathway, the analyst writes.
- Mizuho maintains its Buy rating with a price target of $160.00.
- Price Action: SRPT shares are down 7.03% at $128.00 on the last check Thursday.
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
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