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Sarepta Faces FDA Hold on Gene Therapy Trials

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Sarepta Faces FDA Hold on Gene Therapy Trials

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Sarepta Therapeutics ( (SRPT) ) has shared an announcement.

On July 21, 2025, Sarepta Therapeutics announced that the FDA placed a clinical hold on its investigational gene therapy trials for LGMD, affecting several of its product candidates. This follows a strategic restructuring process announced on July 16, 2025, where the company paused LGMD programs except SRP-9003, for which it completed Phase 3 enrollment and dosing in December 2024. Sarepta plans to discuss with the FDA a potential pathway for accelerated approval of SRP-9003 after the hold is lifted. Additionally, the FDA revoked the platform technology designation for Sarepta’s AAVrh74 platform, initially granted in June 2025.

The most recent analyst rating on (SRPT) stock is a Hold with a $15.00 price target. To see the full list of analyst forecasts on Sarepta Therapeutics stock, see the SRPT Stock Forecast page.

Spark’s Take on SRPT Stock

According to Spark, TipRanks’ AI Analyst, SRPT is a Neutral.

Sarepta Therapeutics is experiencing strong revenue growth but faces significant challenges in profitability and cash flow. The company’s stock is in a bearish technical trend, and valuation metrics suggest risk due to negative earnings and no dividend. The recent earnings call and corporate events show both growth potential and operational challenges, impacting future performance.

To see Spark’s full report on SRPT stock, click here.

More about Sarepta Therapeutics

Sarepta Therapeutics operates in the biotechnology industry, focusing on developing gene therapies for rare neuromuscular diseases, including limb girdle muscular dystrophy (LGMD).

Average Trading Volume: 7,169,396

Technical Sentiment Signal: Sell

Current Market Cap: $1.38B

For detailed information about SRPT stock, go to TipRanks’ Stock Analysis page.

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