Sarepta Therapeutics Inc. (SRPT)
Sarepta finally gets some good news: A patient death wasn't its DMD drug's fault.
Sarepta Therapeutics' stock was soaring Tuesday after the FDA recommended lifting the pause on the company's Duchenne muscular dystrophy drug, but analysts worry it will take time for patients and doctors to feel safe using it.
Sarepta shares surge after FDA lifts pause on muscular dystrophy treatment
Sarepta Therapeutics Inc (NASDAQ:SRPT) shares jumped 25% at the open on Tuesday after the US Food and Drug Administration recommended the company lift a voluntary pause on shipments of its gene therapy ELEVIDYS for ambulatory Duchenne muscular dystrophy (DMD) patients. The regulator's move follows its determination that the death of an eight-year-old patient in Brazil, which had prompted a temporary halt, was unrelated to the therapy.
Sarepta: SRPT Stock To $40?
Sarepta Therapeutics is trading around $19 in extended hours following the FDA's decision to remove the pause on Elevidys, marking a critical turning point for the beleaguered biotech. This regulatory relief, combined with several other compelling catalysts, creates a pathway for the stock to potentially double from current levels to around $40 after its dramatic fall from levels of $170.
Sarepta Stock Drops After Downgrade and FDA Probe. The Crisis Explained.
The outlook for shares is bleak after another batch of worrying headlines.
Sarepta Therapeutics: Beaten Down, But Not Out
SRPT stock now trades at book for the first time ever, despite historically commanding 7x–10x multiples. ELEVIDYS remains FDA-approved for ambulant use and may regain broader access with new protocols underway. Sarepta has $850M in cash, $500M+ in quarterly revenue, and is cutting $400M in costs by 2026.
Opinion | The Sarepta Mugging and Drug Innovation
The Trump FDA tries to kill a therapy that has helped boys with a deadly diagnosis.
US FDA investigates third death after treatment with Sarepta's gene therapy Elevidys
The U.S. Food and Drug Administration said on Friday it was investigating the death of an eight-year-old boy who received Sarepta Therapeutics' muscular disorder gene therapy Elevidys.
How The Negative Developments At Sarepta Therapeutics Impact Arrowhead Pharmaceuticals
Sarepta Therapeutics' recent setbacks and restructuring have pressured Arrowhead's share price due to concerns over milestone payments and clinical program continuity. Arrowhead's financial position remains strong, even with a reduced runway caused by the lack of promised milestone payments from Sarepta. In today's article, I discuss a range of potential outcomes for the collaboration between Sarepta Therapeutics and Arrowhead Pharmaceuticals and what Arrowhead can do with its pipeline and financials.
SRPT Slides on Voluntary US Elevidys Shipment Pause Amid Scrutiny
Sarepta stock down as it halts U.S. Elevidys shipments after FDA pressure and safety concerns tied to patient deaths due to liver failure.
Sarepta Therapeutics' stock slips further as company bows to FDA pressure to halt shipments
Sarepta Therapeutics shares were lower in premarket trading on Tuesday, as the drugmaker relented to a Food and Drug Administration request to halt shipments of a gene therapy.
Sarepta Stock Falls. Why It's Caving Into the FDA and What Comes Next.
The company agreed to voluntarily halt shipments of its experimental medicine Elevidys for Duchenne muscular dystrophy.
Sarepta Therapeutics: Why Is SRPT Stock Crashing?
Sarepta Therapeutics has plunged to new lows below $13, down over 35% in recent trading, after rejecting the FDA's request to voluntarily halt all shipments of Elevidys following a third death tied to the gene therapy. Just days after our previous analyses highlighted the company's apparent undervaluation following its restructuring, its defiant stance has now triggered fresh investor concerns, validating the regulatory risks associated with biotech stocks.
