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Benzinga
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What's Going On With Sarepta, Capricor And Other Gene Therapy Stocks On Wednesday?

1. FDA's Prasad resigns amid pressure and controversy over approvals. 2. Capricor's BLA for Deramiocel received a Complete Response Letter. 3. FDA cites insufficient evidence for Deramiocel, requests additional data. 4. Cell therapy sector struggles with regulatory uncertainty post-Prasad's departure. 5. CAPR stock rose 16.2% despite regulatory challenges.

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FAQ

Why Bearish?

CAPR's BLA received a Complete Response Letter, indicating significant regulatory hurdles. Historical precedent shows that CRLs often result in price declines until uncertainties are resolved.

How important is it?

The article focuses on CAPR's key regulatory challenges, affecting immediate investor sentiment and long-term outlook.

Why Long Term?

CAPR will need to address the FDA's concerns before approval, which could take time. Past examples indicate prolonged approval processes can impact stock performance significantly.

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