Elijah Stacy

Elijah Stacy is a biotech consultant and the founder of Destroy Duchenne. He lives with Duchenne muscular dystrophy. He is a consultant to Capricor Therapeutics and a shareholder; he writes here as a patient, and the views expressed are his own.

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Opinion

FDA’s rare disease framework faces its first real test in Capricor’s DMD drug

Last month, the FDA committed to designing a “fit-for-purpose” framework for regulating rare disease therapies based on patient need and realistically attainable evidence. With the upcoming decision for Capricor’s Duchenne muscular dystrophy cell therapy deramiocel, this paradigm faces its first key test.

November 10, 2026

4 min read

Elijah Stacy