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Wire · regulatory

Capricor soars on potential FDA review extension, filing amendments

14 August 2026 · By · Wire by Fusion42

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, and 7 sources have reported it between 14 Aug 2026 and 25 Aug 2026.

◆ ◆ 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.

◆ Coverage

7 sources · first reported 14 Aug 2026 · latest 25 Aug 2026

◆ Topics

BiotechFDAbiotechdrug-approvalcell-therapyDuchenne-muscular-dystrophy