July 21 - 5 questions on the crisis facing Sarepta, the FDA and Duchenne gene therapy

FDA asks Sarepta to stop shipping Duchenne gene therapy; Alkermes narcolepsy drug headed for late-stage testing; Biotech startup funding dried up in second quarter, HSBC finds

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July 21, 2025 | Today’s news and insights for biopharma leaders

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5 questions on Sarepta, the FDA and a Duchenne gene therapy crisis

A standoff over Elevidys could have major consequences for Duchenne patients, gene therapy companies and the perception of the FDA.

UPDATED

FDA asks Sarepta to stop shipping Duchenne gene therapy

The company refused the FDA’s request and will continue shipping its therapy, Elevidys, to Duchenne patients who can still walk. A pause on shipments to older, non-ambulatory patients remains in place.

Alkermes narcolepsy drug headed for late-stage testing

Part of a class of therapies that boost “orexin” proteins, the drug just scored positive results in a Phase 2 trial. Analysts have guessed it could ultimately generate billions in sales.

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Apples to apples: Stelara biosimilars and the fight for market share

How will payers determine which Stelara biosimilar to add to their formularies?

Biotech startup funding dried up in second quarter, HSBC finds

Overall venture funding, as well as “first financing” rounds, fell significantly in the second quarter, reversing 2025’s fast start, according to HSBC.

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