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Yahoo
7 days ago
- Business
- Yahoo
Sarepta Therapeutics stock sinks further Tuesday, after halting shipment of bestselling therapy Elevidys
Sarepta Therapeutics' (SRPT) stock continued to sink Tuesday following a rough end to last week, including a previously unreported patient death in a clinical trial of an unnamed therapy and the threat of the FDA taking a different therapy, Elevidys, off the market. Both therapies aim to treat different types of muscular dystrophy. The stock was down more than 4% in premarket trade as analysts revived their concerns about the company's future. "Net-net, so long as Elevidys stays on the market (which we think, post digging into FDA's press release on Friday, is certainly the case for ambulatory patients), from current levels, there is upside in SRPT shares," JPMorgan analyst Anupam Rama wrote in a note to clients Monday. "We acknowledge that if we are wrong about Elevidys staying on the market in ambulatory patients, fundamentally, then this would clearly be thesis changing for us." Read more about Sarepta's stock moves and today's market action. While Sarepta agreed to halt shipments in order to sort through the FDA's concerns, there was no suggestion the therapy would be pulled off the market — a point that analysts continue to watch for. The question now is about the company's future and its ability to stay afloat. "Find the stock un-investible near term given nebulousness around Elevidys and how the company will operate from here," Mizuho healthcare expert Jared Holz wrote in a note to clients Tuesday. Elevidys generated $282 million in revenue in the second quarter of this year, or about half of the company's $513 million in net revenue. The patient's death occurred a month ago in a phase 1 trial of the unnamed therapy but was not revealed in an earnings call last week. BioCentury first reported the patient death, which then prompted the FDA to request Sarepta to halt shipments of Elevidys, its Duchenne muscular dystrophy drug. Sarepta refused. That shocked analysts, who on Friday and Saturday said that management's handling of the situation and defiance of the FDA have put investors in "unprecedented times." "This saga continues to get messier, and we are increasingly in unprecedented times, with the FDA requesting Sarepta to suspend the distribution of Elevidys, and the company refusing to do so," Leerink Partners analyst Joseph Schwartz wrote in a note to clients Saturday. Elevydis was also in the crosshairs after two teenagers died earlier this year following treatment, making the latest death the third for the company in a year. Leerink downgraded the stock to Market Perform and lowered its price target to $10 from $14. The company's stock is down 88% year to date. Management's messaging The downturn began just days after Sarepta's second quarter earnings call, in which CEO Doug Ingram said the company would end several clinical trials, including for SRP-9004, as part of a restructuring. But none of the executives on the call mentioned the death. On a call with investors Friday, Ingram attempted to quell concerns that ending some research programs was related to the death and was focused instead on the need to cut costs. "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 at the start of the call Friday. He described the patient as a 51-year-old late-stage nonambulatory male. "After only recently learning about a death that occurred a month ago ... [we are] losing any remaining confidence we had in the management team, and seeing the headlines that the FDA will request SRPT to voluntarily stop all shipments of Elevidys (SRP-9001) in Duchenne muscular dystrophy (DMD), we stepped to the sidelines and downgraded the stock," Leerink's Schwartz wrote. Jefferies analyst Andrew Tsai said the revelation could make Sarepta's stock less appealing. "Seeing a third SRPT-related death occur within a span of 4 months will raise questions about SRPT's gene therapy platform," Tsai wrote on Friday. "Serious downside risks (i.e. deaths) have been challenging to handicap, which could cause near-term stock exhaustion." In a statement Friday, following the FDA's request to halt Elevidys, Sarepta said it did not see a reason to acquiesce. "Based on our comprehensive scientific interpretation of the data, which shows no new or changed safety signals in the ambulant patient population, we will continue to ship Elevidys to the ambulant population. We look forward to continued discussions and sharing of information with FDA in order to advance our shared purpose of protecting patient safety and informed access to care," the company said in a statement Friday. Weekend turnaround Over the weekend, management spoke with analysts and appeared to have allayed some concerns. They told analysts that the FDA was aware of the death and that the agency's sudden request to pull Elevidys was not valid. "Regarding the FDA's request that SRPT voluntarily stop all shipments of Elevidys (SRP-9001) in Duchenne muscular dystrophy (DMD), management agreed with our thoughts that this was seemingly in reaction to the headlines on Friday, rather than a decision rooted in science or regulatory precedent, especially as the agency has been aware of the death ... for quite some time," Leerink's Schwartz wrote. Others, like JPMorgan's Rama, noted that the FDA is unlikely to pull the drug off the market for the population unaffected by the drug — the mobile, or ambulatory, population. Meanwhile, Jefferies analyst Andrew Tsai held a more cautious tone. "We acknowledge the story could be challenging to navigate after a third patient death, but we are merely assessing the situation as more information becomes available," he wrote in a note to clients on Sunday. "Despite the FDA's request to halt Elevidys shipments, SRPT will elect to continue shipping the gene therapy to ambulatory DMD patients. Since we are unsure if the FDA can pull Elevidys, the logical question is how Elevidys sales will trend amid increased uncertainty and pot'l FDA controversy." Sarepta's management also told analysts that if it were forced to pull Elevidys, it would have to cut more costs in order to stay afloat. 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 Sign in to access your portfolio
Yahoo
21-07-2025
- Business
- Yahoo
Sarepta Therapeutics stock sinks after FDA tells company to stop shipping its bestselling drug
Sarepta Therapeutics' (SRPT) stock continued to sink Monday, down more than 8% in early trade though quickly paring losses following a rough end to last week, including a previously unreported patient death in a clinical trial of an unnamed therapy and the threat of the FDA taking a different therapy, Elevidys, off the market. Both therapies aim to treat different types of muscular dystrophy. This extended decline in the stock comes even as analysts have pared back their concerns over the weekend, after Wall Street sent the stock into free fall on Friday, down 35% at the close of trading. "Net-net, so long as Elevidys stays on the market (which we think, post digging into FDA's press release on Friday, is certainly the case for ambulatory patients), from current levels, there is upside in SRPT shares. We acknowledge that if we are wrong about Elevidys staying on the market in ambulatory patients, fundamentally, then this would clearly be thesis changing for us," JPMorgan analyst Anupam Rama wrote in a note to clients Monday. Elevidys generated $282 million in revenues in the second quarter of this year, or about half of the company's $513 million in net revenues. The patient death occurred a month ago in a phase 1 trial of the unnamed therapy but was not revealed in an earnings call last week. BioCentury first reported the patient death, which then prompted the FDA to request Sarepta to halt shipments of Elevidys, its Duchenne muscular dystrophy drug. Sarepta refused. That shocked analysts who on Friday and Saturday said that management's handling of the situation, as well as its defiance of the FDA, has put investors in "unprecedented times." "This saga continues to get messier, and we are increasingly in unprecedented times, with the FDA requesting Sarepta to suspend the distribution of Elevidys, and the company refusing to do so," Leerink Partners analyst Joseph Schwartz wrote in a note to clients Saturday. Elevydis was also in the crosshairs after two teenagers died earlier this year following treatment, making the latest death the third for the company in a year. Leerink downgraded the stock to Market Perform and lowered its price target to $10 from $14. The company's stock is down 88% year to date. Read more about Sarepta's stock moves and today's market action. Management's messaging The downturn began just days after Sarepta's second quarter earnings call, in which CEO Doug Ingram said the company would end several clinical trials, including for SRP-9004, as part of a restructuring. But none of the executives on the call mentioned the death. On a call with investors Friday, Ingram attempted to quell concerns that ending some research programs was related to the death and was focused instead on the need to cut costs. "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 at the start of the call Friday. He described the patient as a 51-year-old late-stage, nonambulatory male. "After only recently learning about a death that occurred a month ago ... [we are] losing any remaining confidence we had in the management team, and seeing the headlines that the FDA will request SRPT to voluntarily stop all shipments of Elevidys (SRP-9001) in Duchenne muscular dystrophy (DMD), we stepped to the sidelines and downgraded the stock," Leerink's Schwartz wrote in a note to clients Friday. Jefferies analyst Andrew Tsai said the revelation could make Sarepta's stock less appealing. "Seeing a third SRPT-related death occur within a span of 4 months will raise questions about SRPT's gene therapy platform," Tsai wrote on Friday. "Serious downside risks (i.e. deaths) have been challenging to handicap, which could cause near-term stock exhaustion." In a statement Friday, following the FDA's request to halt Elevidys, Sarepta said it did not see a reason to acquiesce. "Based on our comprehensive scientific interpretation of the data, which shows no new or changed safety signals in the ambulant patient population, we will continue to ship Elevidys to the ambulant population. We look forward to continued discussions and sharing of information with FDA in order to advance our shared purpose of protecting patient safety and informed access to care," the company said in a statement Friday. Weekend turnaround Over the weekend, management spoke with analysts and appeared to have allayed some concerns. They told analysts that the FDA was aware of the death and that the agency's sudden request to pull Elevidys was not valid. "Regarding the FDA's request that SRPT voluntarily stop all shipments of Elevidys (SRP-9001) in Duchenne muscular dystrophy (DMD), management agreed with our thoughts that this was seemingly in reaction to the headlines on Friday, rather than a decision rooted in science or regulatory precedent, especially as the agency has been aware of the death ... for quite some time," Leerink's Schwartz wrote. Others, like JPMorgan's Rama, noted that the FDA is unlikely to pull the drug off the market for the population unaffected by the drug — the mobile, or ambulatory, population. Meanwhile, Jefferies analyst Andrew Tsai held a more cautious tone. "We acknowledge the story could be challenging to navigate after a third patient death, but we are merely assessing the situation as more information becomes available," he wrote in a note to clients on Sunday. "Despite the FDA's request to halt Elevidys shipments, SRPT will elect to continue shipping the gene therapy to ambulatory DMD patients. Since we are unsure if the FDA can pull Elevidys, the logical question is how Elevidys sales will trend amid increased uncertainty and pot'l FDA controversy." Sarepta's management also told analysts that if it were forced to pull Elevidys, it would have to cut more costs in order to stay afloat. 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
20-07-2025
- Business
- Yahoo
JP Morgan Maintains a Neutral Stance on ProKidney Corp. (PROK)
ProKidney Corp. (NASDAQ:PROK) is one of the . On July 15, JP Morgan analyst Anupam Rama maintained a neutral stance on ProKidney Corp. (NASDAQ:PROK), giving the stock a Hold rating without a price target. A scientist in a laboratory examining a microscope in the pursuit of cell therapy discoveries. The analyst based the rating on the company's current developments. He acknowledged that ProKidney Corp.'s (NASDAQ:PROK) recent alignment with the FDA for an accelerated approval pathway for rilparencel is an optimistic development and highlights progress in its pivotal PROACT 1 study. However, Rama also stated that the time for the attainment of necessary data for the accelerated approval is longer than previously expected, as key data is expected to roll out in Q2 2027. The analyst thus reasoned that although there have been notable optimistic updates in the trial, the extended timeline may weigh on investor sentiment, warranting a cautious outlook on the stock. ProKidney Corp. (NASDAQ:PROK) is a clinical-stage biotechnology company that develops a proprietary cell therapy platform. The company's emphasis is on chronic kidney disease treatment, shifting focus to kidney function restoration to delay or stop the progression of CKD. While we acknowledge the potential of PROK as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 30 Stocks That Should Double in 3 Years and 11 Hidden AI Stocks to Buy Right Now. Disclosure: None. This article is originally published at Insider Monkey. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Insider
23-06-2025
- Business
- Business Insider
Sage Therapeutics price target lowered to $8.50 from $11 at JPMorgan
JPMorgan analyst Anupam Rama lowered the firm's price target on Sage Therapeutics (SAGE) to $8.50 from $11 and keeps a Neutral rating on the shares. The firm cites the acquisition deal price by Supernus Pharmaceuticals for the target cut. Confident Investing Starts Here: Easily unpack a company's performance with TipRanks' new KPI Data for smart investment decisions Receive undervalued, market resilient stocks right to your inbox with TipRanks' Smart Value Newsletter Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>>
Business Insider
23-06-2025
- Business
- Business Insider
J.P. Morgan Remains a Hold on SAGE Therapeutics (SAGE)
In a report released on June 20, Anupam Rama from J.P. Morgan maintained a Hold rating on SAGE Therapeutics (SAGE – Research Report), with a price target of $8.50. The company's shares closed last Friday at $9.30. Confident Investing Starts Here: Easily unpack a company's performance with TipRanks' new KPI Data for smart investment decisions Receive undervalued, market resilient stocks right to your inbox with TipRanks' Smart Value Newsletter Rama covers the Healthcare sector, focusing on stocks such as Neurocrine, Sarepta Therapeutics, and Vera Therapeutics. According to TipRanks, Rama has an average return of -6.9% and a 37.70% success rate on recommended stocks. SAGE Therapeutics has an analyst consensus of Hold, with a price target consensus of $9.04, which is a -2.80% downside from current levels. In a report released on June 20, Robert W. Baird also maintained a Hold rating on the stock with a $9.00 price target. The company has a one-year high of $13.47 and a one-year low of $4.62. Currently, SAGE Therapeutics has an average volume of 1.52M.
