Latest news with #Sarepta
Business Insider
2 days ago
- Business
- Business Insider
Wainwright Analyst Slaps $0 Price Target on Sarepta Stock (SRPT)
Sarepta Therapeutics (SRPT) is under mounting Wall Street scrutiny amid safety concerns surrounding its flagship gene therapy, Elevidys. In a striking call, analyst Mitchell Kapoor at H.C. Wainwright assigned a $0 price target to SRPT stock, citing the tension between the company and the FDA (Food and Drug Administration). Meanwhile, Kapoor maintained his Sell rating on SRPT stock. Elevate Your Investing Strategy: Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence. SRPT stock has plunged more than 30% over the past five trading days, following Friday's news that the FDA requested Sarepta halt all shipments of Elevidys. In response, the company announced a voluntary pause in U.S. shipments of the therapy. For context, Elevidys is a one-time gene therapy from Sarepta that treats Duchenne muscular dystrophy (DMD) in patients aged four and up. HC Wainwright Sees FDA Clash as 'Unwinnable' Kapoor's rare price target cut comes after Sarepta initially refused to voluntarily pause Elevidys shipments, despite an FDA request following three patient deaths linked to the treatment. Additionally, Kapoor called the conflict with the FDA 'unwinnable' and warned that regulators are likely to force Elevidys off the market. A potential withdrawal could wipe out the therapy's revenue stream, leaving Sarepta stock effectively worthless. He also cautioned investors against single-product biotech companies, warning that such a business model may not be sustainable. Other Analysts Weigh In on SRPT Stock After Friday's decline, more than six analysts have downgraded their ratings on Sarepta stock. Notably, both Deutsche Bank Securities and Needham & Co. issued Sell ratings. Needham's analyst Gil Blum believes the ongoing 'showdown' between the FDA and Sarepta will likely end with formal regulatory action against Elevidys. He also warns that a potential market withdrawal could jeopardize Sarepta's ability to meet its $1.15 billion debt obligations due in 2027. On the other hand, J.P. Morgan's analyst Anupam Rama reiterated his Buy rating on SRPT stock, predicting an upside of over 50%. Rama believes Elevidys will likely remain available for ambulatory patients, as no deaths have been reported in that subgroup to date. These patients can walk independently or with minimal support. What is SRPT's Stock Price Forecast? According to TipRanks, Wall Street has a Hold consensus rating on SRPT stock, based on six Buys, 17 Holds, and three Sells assigned in the last three months. The average Sarepta Therapeutics stock price target of $30.82 implies a 131.4% upside potential.
Boston Globe
2 days ago
- Health
- Boston Globe
Sarepta Therapeutics says it will pause shipments of Duchenne gene therapy
'This proactive step will allow Sarepta the necessary time to respond to any requests for information and allow Sarepta and FDA to complete the Elevidys safety labeling supplement process,' said Sarepta CEO Doug Ingram, in a statement. The decision wasn't entirely in Sarepta's control. On Monday, Children's Hospital Los Angeles (CHLA) said it was pausing use of Elevidys while the drug is in regulatory limbo. Get Starting Point A guide through the most important stories of the morning, delivered Monday through Friday. Enter Email Sign Up 'Patient safety is paramount at CHLA and the hospital has communicated its decision with affected patient families while it awaits any further determination by the FDA,' the hospital told STAT. Advertisement Other hospitals that specialize in the treatment of Duchenne patients are reportedly considering similar treatment pauses. Sarepta may have also realized that fighting with the FDA was high-risk. 'It is important for the patients we serve that Sarepta maintains a productive and positive working relationship with FDA, and it became obvious that maintaining that productive working relationship required this temporary suspension,' said Ingram, in the statement. Sarepta did not indicate how long the Elevidys suspension might last. Ritu Baral, a biotech analyst at Cowen, estimated 3 to 6 months. During that time the company would test a proposed immune-suppressing protocol designed to mitigate the serious liver toxicity caused by the gene therapy, and share those data with the FDA. Advertisement In a statement, Parent Project Muscular Dystrophy, a patient advocacy organization, said the FDA demand to halt Elevidys shipments and Sarepta's agreement to do so has 'intensified concerns and uncertainty' for Duchenne patients and their families. 'We deeply value the importance of data-driven decision-making and responsible regulatory oversight. We urge both Sarepta and the FDA to communicate with urgency, clarity, and transparency about the path forward,' the group said. On Friday, the FDA asked Sarepta to pause all shipments of Elevidys following media reports of the death of a 51-year-old man who received a different but related gene therapy for a different form of muscular dystrophy. That death followed the deaths in March and June of two teenagers who received Elevidys. Sarepta had already paused shipments for patients who rely on wheelchairs — boys with Duchenne typically lose the ability to walk around age 12. But the company initially said it would not comply with the FDA's request to also halt shipments for ambulatory patients. To agree would mean a de facto withdrawal of the therapy from the market. But on Monday, the company reversed course. Elevidys has appeared safer and more effective in ambulant Duchenne patients, who are generally younger, but significant side effects can still occur. Scheduled infusions across the country will now be canceled.
Time of India
2 days ago
- Business
- Time of India
Sarepta shares fall 7% after gene therapy maker pauses Elevidys shipments in US
Shares of Sarepta Therapeutics fell nearly 7% on Tuesday after the company agreed to comply with the U.S. health regulator's request to pause all shipments of its gene therapy Elevidys in the United States. The U.S. Food and Drug Administration on Friday asked Sarepta to voluntarily halt shipments of the gene therapy, but the company refused to do so and said it would continue making the treatment available to ambulatory patients. Explore courses from Top Institutes in Please select course: Select a Course Category Product Management Technology Degree Others Management Artificial Intelligence Public Policy MCA others PGDM healthcare Design Thinking Operations Management Finance Data Analytics Project Management MBA CXO Digital Marketing Leadership Data Science Data Science Skills you'll gain: Product Strategy & Competitive Advantage Tactics Product Development Processes & Market Orientations Product Analytics & Data-Driven Decision Making Agile Development, Design Thinking, & Product Leadership Duration: 40 Weeks IIM Kozhikode Professional Certificate in Product Management Starts on Jun 26, 2024 Get Details Skills you'll gain: Product Strategy & Roadmapping User-Centric Product Design Agile Product Development Market Analysis & Product Launch Duration: 24 Weeks Indian School of Business Professional Certificate in Product Management Starts on Jun 26, 2024 Get Details Skills you'll gain: Creating Effective Product Roadmap User Research & Translating it to Product Design Key Metrics via Product Analytics Hand-On Projects Using Cutting Edge Tools Duration: 12 Weeks Indian School of Business ISB Product Management Starts on May 14, 2024 Get Details by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Trekking pants for mountain sports and adventure travel Trek Kit India Shop Now But Sarepta has now voluntarily and temporarily paused all shipments of the therapy, effective end of Tuesday. The company said the decision would allow it to respond to requests from the FDA and maintain a positive relationship with the agency. "Though Sarepta claims its pause in shipments was voluntary, we think the company moved preemptively - bracing for an inevitable FDA mandate to pull the drug," said H.C. Wainwright analyst Mitchell Kapoor. Shares of Sarepta fell 6.9% to $12.40 in early trading on Tuesday. Live Events "Sarepta's decision to comply was a capitulation after recognizing that the fight with the FDA was not winnable and that the agency would have strong-armed Sarepta into removing Elevidys with a formal demand," Kapoor added. Investor concerns regarding the use of the company's treatments have been heightened after the company on Friday disclosed that another patient who had received its experimental gene therapy died from acute liver failure , marking the third death this year. The company's shares have plummeted 89% so far this year. On Monday, Children's Hospital Los Angeles said it had paused usage of Elevidys in all patients with muscular dystrophy . The FDA's initial request had likely heightened the pressure on physicians to pause treatments, which could also have been a driving factor in Sarepta's decision, William Blair analyst Sami Corwin said.
Bloomberg
3 days ago
- Health
- Bloomberg
Sarepta Warnings Came Long Before Its Standoff With US Regulators
Hi, it's Bob in New York. Sarepta Therapeutics announced it will pause all shipments of Elevidys in the US. I spoke to one mother who tried to raise the alarm bell a month before the FDA took action, but first... After Sarepta's dramatic back-and-forth with the Food and Drug Administration, I started reaching out to patients and their families to see how they were feeling about the company's controversial gene therapies.
Business Insider
3 days ago
- Business
- Business Insider
Sarepta announces voluntary pause of Elevidys shipments in the U.S.
Sarepta (SRPT) Therapeutics issued the following statement: 'Sarepta Therapeutics notified the U.S. Food and Drug Administration (FDA) of its decision to voluntarily and temporarily pause all shipments of ELEVIDYS (delandistrogene moxeparvovec) for Duchenne muscular dystrophy in the United States, effective close of business Tuesday, July 22, 2025. This proactive step will allow Sarepta the necessary time to respond to any requests for information and allow Sarepta and FDA to complete the ELEVIDYS safety labeling supplement process. The Company looks forward to a collaborative, science-driven review process and dialogue with the FDA.' 'As a patient-centric organization, the decision to voluntarily and temporarily pause shipments of ELEVIDYS was a painful one, as individuals with Duchenne are losing muscle daily and in need of disease-modifying options,' said Doug Ingram, chief executive officer, Sarepta. 'It is important for the patients we serve that Sarepta maintains a productive and positive working relationship with FDA, and it became obvious that maintaining that productive working relationship required this temporary suspension while we address any questions that FDA may have and complete the ELEVIDYS label supplement process.' Sarepta remains committed to transparency and patient safety and will continue to provide timely updates to patients, families, healthcare providers, and the broader Duchenne community as additional information becomes available. Elevate Your Investing Strategy:
