Sarepta says will continue to ship Elevidys to ambulant population
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Yahoo
an hour ago
- Yahoo
Sarepta stock faces multiple downgrades and questions of solvency amid Elevidys pause
Sarepta Therapeutics' (SRPT) stock has been hammered in the past week after the company was forced to pause shipments of its top-selling Duchenne muscular dystrophy (DMD) therapy Elevidys — throwing the future of the company into question. Elevidys netted $821 million of the company's $1.78 billion in 2024 revenue and contributed to more than 50% of the company's $513 million in second quarter revenue this year. It's the company's top-selling product. It's why seven analysts have downgraded the stock since Friday, including Bank of America's Tazeen Ahmad on Wednesday. Ahmad downgraded the stock to Underperform and revised the firm's price target to $10 from $20. The stock is currently trading at $13.90 per share and closed down more than 2% on Wednesday. Sarepta "has requested a meeting with FDA and might have more visibility on length of the pause once FDA responds to their submission for a revised label," Ahmad wrote in a note to clients. "In short, we think this could impact the Elevidys brand further, limiting uptake following highly focused media attention as well as a renewed chance of Elevidys being removed from the US market." Leerink Partners downgraded the stock last week from Outperform to Market Perform. Analyst Joseph Schwartz wrote in a note to clients on Monday that how long the pause lasts is important for future modeling. "This decision is also roughly aligned with our published SRPT model, which assumes a significant slowing of sales in the third quarter, zero sales in the fourth quarter, and a resumption of shipments in early 2026," Schwartz wrote. "We lack visibility into how long this pause may last, or what the intermediate scenarios are from here (e.g., a narrower approval)." The stock now has five Buy, 17 Hold, and four Sell ratings. Domino effect The technology to deliver the therapy in Elevidys is at the center of the issue facing the company. A 51-year-old, late-stage patient in a phase 1 trial of a different muscular dystrophy therapy, known only by its trial name, SRP-9004, died from liver toxicity last month, but Sarepta failed to disclose the death — even as it announced it was discontinuing the trial as part of a restructuring last week. That began the domino effect of downgrades and the stock sell-off as analysts questioned why the company had kept quiet. On a call with investors Friday, CEO Doug Ingram defended his reasoning for not mentioning it. "We did not discuss this matter in our call on Wednesday because it was neither material nor central to the topics at hand on Wednesday," Ingram said. In a note following the call, Leerink's Schwartz wrote, "Is This Material?!? All Credibility Lost." It's the third death linked to a gene therapy from the company this year and a reason why the FDA previously required the company to add new warning labels to Elevidys, which is part of the pause in shipments currently. But now, the company's future is in flux as its revenue stream has been paused for an undetermined amount of time. Jefferies analyst Andrew Tsai, one of the few who has maintained a Buy rating, said the company could defend the therapy as sicker and older patients have been more negatively impacted, while younger patients who are still able to move independently have benefited. "Prior to the third death, SRPT's internal stress tests suggested the DMD franchise could 'floor' at $1.4B annually into 2027, including $500M+ for Elevidys in ambulatory," Tsai wrote in a note to clients Sunday. "For Elevidys, one can point to how the deaths have occurred only in older patients." "More cost reductions is possible too," Tsai noted of how Sarepta could end up handling the hit. Anjalee Khemlani is the senior health reporter at Yahoo Finance, covering all things pharma, insurance, provider services, digital health, PBMs, and health policy and politics. That includes GLP-1s, of course. Follow Anjalee as AnjKhem on social media platforms X, LinkedIn, and Bluesky @AnjKhem. Click here for in-depth analysis of the latest health industry news and events impacting stock prices
Yahoo
2 hours ago
- Yahoo
Sarepta stock faces multiple downgrades and questions of solvency amid Elevidys pause
Sarepta Therapeutics' (SRPT) stock has been hammered in the past week after the company was forced to pause shipments of its top-selling Duchenne muscular dystrophy (DMD) therapy Elevidys — throwing the future of the company into question. Elevidys netted $821 million of the company's $1.78 billion in 2024 revenue and contributed to more than 50% of the company's $513 million in second quarter revenue this year. It's the company's top-selling product. It's why seven analysts have downgraded the stock since Friday, including Bank of America's Tazeen Ahmad on Wednesday. Ahmad downgraded the stock to Underperform and revised the firm's price target to $10 from $20. The stock is currently trading at $13.90 per share and closed down more than 2% on Wednesday. Sarepta "has requested a meeting with FDA and might have more visibility on length of the pause once FDA responds to their submission for a revised label," Ahmad wrote in a note to clients. "In short, we think this could impact the Elevidys brand further, limiting uptake following highly focused media attention as well as a renewed chance of Elevidys being removed from the US market." Leerink Partners downgraded the stock last week from Outperform to Market Perform. Analyst Joseph Schwartz wrote in a note to clients on Monday that how long the pause lasts is important for future modeling. "This decision is also roughly aligned with our published SRPT model, which assumes a significant slowing of sales in the third quarter, zero sales in the fourth quarter, and a resumption of shipments in early 2026," Schwartz wrote. "We lack visibility into how long this pause may last, or what the intermediate scenarios are from here (e.g., a narrower approval)." The stock now has five Buy, 17 Hold, and four Sell ratings. Domino effect The technology to deliver the therapy in Elevidys is at the center of the issue facing the company. A 51-year-old, late-stage patient in a phase 1 trial of a different muscular dystrophy therapy, known only by its trial name, SRP-9004, died from liver toxicity last month, but Sarepta failed to disclose the death — even as it announced it was discontinuing the trial as part of a restructuring last week. That began the domino effect of downgrades and the stock sell-off as analysts questioned why the company had kept quiet. On a call with investors Friday, CEO Doug Ingram defended his reasoning for not mentioning it. "We did not discuss this matter in our call on Wednesday because it was neither material nor central to the topics at hand on Wednesday," Ingram said. In a note following the call, Leerink's Schwartz wrote, "Is This Material?!? All Credibility Lost." It's the third death linked to a gene therapy from the company this year and a reason why the FDA previously required the company to add new warning labels to Elevidys, which is part of the pause in shipments currently. But now, the company's future is in flux as its revenue stream has been paused for an undetermined amount of time. Jefferies analyst Andrew Tsai, one of the few who has maintained a Buy rating, said the company could defend the therapy as sicker and older patients have been more negatively impacted, while younger patients who are still able to move independently have benefited. "Prior to the third death, SRPT's internal stress tests suggested the DMD franchise could 'floor' at $1.4B annually into 2027, including $500M+ for Elevidys in ambulatory," Tsai wrote in a note to clients Sunday. "For Elevidys, one can point to how the deaths have occurred only in older patients." "More cost reductions is possible too," Tsai noted of how Sarepta could end up handling the hit. Anjalee Khemlani is the senior health reporter at Yahoo Finance, covering all things pharma, insurance, provider services, digital health, PBMs, and health policy and politics. That includes GLP-1s, of course. Follow Anjalee as AnjKhem on social media platforms X, LinkedIn, and Bluesky @AnjKhem. Click here for in-depth analysis of the latest health industry news and events impacting stock prices
Bloomberg
2 hours ago
- Bloomberg
Sarepta Needs to Show FDA Elevidys Won't Cause More Deaths
The Food and Drug Administration won't sign off on Sarepta Therapeutics Inc. bringing its controversial gene therapy back to the market until the company can persuade US regulators that it won't cause more deaths, according to an official familiar with the situation. The FDA has not seen a convincing explanation as to why Sarepta's gene therapy for Duchenne muscular dystrophy, Elevidys, was tied to two fatal cases of liver failure, the official said, and there may be no single, easily addressable problem the company can quickly fix. A third fatal case of liver failure that occurred during a trial of a separate but similar Sarepta gene therapy is unquestionably relevant information to the safety of Elevidys, said the official, who declined to be identified because the agency's deliberations are private.
