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Capricor soars on potential FDA review extension, filing amendments

Published

14 August 2026

Topic

regulatory

Sectors

Biotech

Geography

United States

Source

Read at biospace.com

Verified

Fusion42 · 14 August 2026 · Fusion42 review

Capricor Therapeutics is working with the FDA to potentially extend the review deadline for its Duchenne muscular dystrophy therapy deramiocel by submitting new open-label extension data and amendments, prompting a 68% surge in the company's stock.

This Wire brief sits within Fusion42's coverage of Biotech. Wire is Fusion42's founder-focused intelligence feed: each story is connected to the funds and startups it names — every one with a live profile on Raise or Scout — so founders can follow the capital and the momentum behind the headline rather than just the headline itself. Wire analysis is one of the live surfaces Arthur reasons over.

◆ The Wire takeaway

FDA's willingness to extend the review for deramiocel opens a rare regulatory window for biotech founders navigating contentious approval processes. You need to revisit ongoing FDA discussions now to explore similar amendment opportunities before definitive rejection.

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Topics

BiotechFDAbiotechdrug-approvalcell-therapyDuchenne-muscular-dystrophy