FDA warns investors that advisory panel reviews do not guarantee drug approval, cites concerns at Capricor and Replimune

The FDA issued a reminder to investors that the outcomes of advisory committee meetings are not final decisions on a drug’s fate.

This week the agency released briefing documents highlighting concerns about clinical data submitted by Capricor Therapeutics and Replimune, two companies whose stocks fell sharply after the notices.

The FDA noted that it may request additional information or re‑evaluate the data, but such steps do not automatically lead to approval or rejection.

Investors are urged to consider the provisional nature of advisory panel feedback when assessing the risk profile of biotech investments.