Data News > Post Market Movers: Sarepta Therapeutics Faces Regulatory Challenges Amid Voluntary Pause of ELEVIDYS Shipments

Post Market Movers: Sarepta Therapeutics Faces Regulatory Challenges Amid Voluntary Pause of ELEVIDYS Shipments

By KlickAnalytics Data Insights  |   July 21, 2025 08:06PM ET

Key Points

- Sarepta Therapeutics voluntarily paused shipments of ELEVIDYS in the U.S. for Duchenne muscular dystrophy
- Children's Hospital LA stopped using Sarepta gene therapy for muscular dystrophy patients
- Shareholders experiencing losses urged to contact The Gross Law Firm about pending Class Action
- FDA placed Sarepta's gene therapy clinical trials for limb girdle muscular dystrophy on hold
- Sarepta stock plummeted after a third death in its gene therapy program prompted FDA action

Sarepta Therapeutics, a leading provider of precision genetic medicine for rare diseases, has made the decision to temporarily halt all shipments of ELEVIDYS, a gene therapy for Duchenne muscular dystrophy, in the United States. The company notified the U.S. Food and Drug Administration (FDA) of this voluntary pause, which went into effect on Tuesday, July 22, 2025. This proactive measure is aimed at addressing concerns surrounding the safety and efficacy of the product.

In response to recent FDA actions, Children's Hospital Los Angeles announced that it would be suspending the use of Sarepta Therapeutics' gene therapy, Elevidys, for all patients with muscular dystrophy. This decision comes amidst growing scrutiny over the safety of the treatment, particularly in light of recent incidents involving patient deaths.

Shareholders who have suffered financial losses as a result of their investments in Sarepta Therapeutics are encouraged to reach out to The Gross Law Firm regarding a pending Class Action lawsuit against the company. The legal action seeks to address any violations of federal securities laws that may have contributed to investor losses.

The FDA's decision to place Sarepta Therapeutics' investigational gene therapy clinical trials for limb girdle muscular dystrophy on hold has further compounded the company's regulatory challenges. This move underscores the heightened scrutiny surrounding Sarepta's gene therapy programs and raises concerns about the company's path forward in the development of these treatments.

Following the news of a third death in its muscular dystrophy gene therapy program, Sarepta Therapeutics saw its stock price plummet, prompting FDA intervention and intensifying safety concerns. The company's defiant stance in response to regulatory requests has further eroded investor confidence and exacerbated the crisis facing the biotech firm.

Amidst mounting challenges and regulatory scrutiny, Sarepta Therapeutics remains at the center of a complex legal and financial landscape. The voluntary pause of ELEVIDYS shipments, combined with ongoing investigations and investor actions, underscores the turbulent period that the company is navigating. Investors are advised to closely monitor developments and consider their options carefully in light of these unfolding events.

About SRPT
Sarepta Therapeutics, Inc., a commercial-stage biopharmaceutical company, focuses on the discovery and development of RNA-targeted therapeutics, gene therapies, and other genetic therapeutic modalities for the treatment of rare diseases. It offers EXONDYS 51 injection to treat duchenne muscular dystrophy (duchenne) in patients with confirmed mutation of the dystrophin gene that is amenable to exon 51 skipping; and VYONDYS 53 for the treatment of duchenne in patients with confirmed mutation of the dystrophin gene that is amenable to exon 53 skipping. The company is also developing AMONDYS 45, a product candidate that uses phosphorodiamidate morpholino oligomer chemistry and exon-skipping technology to skip exon 45 of the dystrophin gene; SRP-5051, a peptide conjugated PMO that binds exon 51 of dystrophin pre-mRNA; SRP-9001, a DMD micro-dystrophin gene therapy program; and SRP-9003, a limb-girdle muscular dystrophies gene therapy program. It has collaboration agreements with F. Hoffman-La Roche Ltd; Nationwide Children's Hospital; Lysogene; Duke University; Genethon; and StrideBio. The company was incorporated in 1980 and is headquartered in Cambridge, Massachusetts.

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