Sarepta Therapeutics (NASDAQ:SRPT) faces an “arduous and treacherous path” to bring its gene therapy Elevidys back to market, according to a STAT report citing a senior FDA official, suggesting the treatment’s license could be revoked amid ongoing safety concerns.

Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today issued the following statement:

The FDA has placed multiple investigational gene therapy clinical trials on hold, signaling broader platform concerns.

Sarepta Therapeutics' recent setbacks and restructuring have pressured Arrowhead's share price. Read why I am reiterating my bullish rating on ARWR stock.

Sarepta faces FDA scrutiny over Elevidys as analysts downgrade stock and warn of long-term debt risks amid market uncertainty.