From left, STAT’s Adam Feuerstein chats with Capricor Therapeutics CEO Linda Marbán and Replimune CEO Sushil Patel at the STAT Summit in Boston on Wednesday.Jeff Pinette for STAT

By Lizzy Lawrence

Oct. 16, 2025

FDA Reporter

Lizzy Lawrence

[email protected]

Lizzy Lawrence leads STAT’s coverage of the Food and Drug Administration. She was previously a medical devices reporter. You can reach Lizzy on Signal at lizzylaw.53.

BOSTON — Replimune Group and Capricor Therapeutics both seemed on track to receive long-awaited drug approvals from the Food and Drug Administration earlier this year. 

Then, amid tumult at the agency as the Trump administration took power, their applications were rejected. The companies’ CEOs talked about the importance of a stable FDA at the STAT Summit on Wednesday.

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“It is going to kill drug development if you don’t have consistency and transparency,” said Replimune CEO Sushil Patel. “It’s really going to make it very difficult for us to bring innovative treatments to patients faster.”

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  1. Lizzy Lawrence

    FDA Reporter

    Lizzy Lawrence leads STAT’s coverage of the Food and Drug Administration. She was previously a medical devices reporter. You can reach Lizzy on Signal at lizzylaw.53.