Latest news with #ELEVIDYS
Yahoo
14 hours ago
- Business
- Yahoo
Sarepta Therapeutics (NasdaqGS:SRPT) Gains 19% Over Past Month Following Japan Approval
Sarepta Therapeutics saw its share price rise by 19% over the past month, a move that notably outpaced the broader market's 1% increase for the week and the 13% gain over the year. This significant increase can be partially attributed to several key announcements, including the FDA's platform technology designation for their rAAVrh74 viral vector, pivotal updates from ongoing studies related to their ELEVIDYS treatment for Duchenne Muscular Dystrophy, and new approval in Japan. These developments highlight the company's continued progress and innovation in gene therapy, reinforcing investor confidence amidst market growth. We've identified 2 weaknesses for Sarepta Therapeutics (1 is a bit concerning) that you should be aware of. Diversify your portfolio with solid dividend payers offering reliable income streams to weather potential market turbulence. Recent developments for Sarepta Therapeutics have sparked a positive response in short-term share price, primarily driven by advancements in their gene therapy programs. These innovations, particularly the FDA's designation and updates on the ELEVIDYS program, are poised to bolster investor confidence. However, despite this optimism, it's essential to acknowledge that Sarepta's shares have experienced a 37.80% decline over the past three years, highlighting challenges the company has faced. Relative to the biotechnology industry, Sarepta has underperformed in the past year compared to the US Biotechs market, which returned -9.3%. The recent announcements could potentially impact Sarepta's revenue and earnings forecasts considerably. Analysts project a significant annual revenue increase over the next three years, with expectations that profit margins will improve. Crucially, these updates could address operational delays and safety concerns surrounding ELEVIDYS, enhancing the therapy's credibility and market uptake. In terms of valuation, Sarepta's recent share price movements are in the context of an analyst price target of US$89.96, indicating further room for growth if the company's strategic objectives translate into financial success. These factors collectively shape a complex but promising outlook for Sarepta as it navigates both opportunities and challenges in its field. The valuation report we've compiled suggests that Sarepta Therapeutics' current price could be quite moderate. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include NasdaqGS:SRPT. This article was originally published by Simply Wall St. Have feedback on this article? Concerned about the content? with us directly. Alternatively, email editorial-team@ 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
Yahoo
14 hours ago
- Business
- Yahoo
Sarepta Therapeutics (NasdaqGS:SRPT) Gains 19% Over Past Month Following Japan Approval
Sarepta Therapeutics saw its share price rise by 19% over the past month, a move that notably outpaced the broader market's 1% increase for the week and the 13% gain over the year. This significant increase can be partially attributed to several key announcements, including the FDA's platform technology designation for their rAAVrh74 viral vector, pivotal updates from ongoing studies related to their ELEVIDYS treatment for Duchenne Muscular Dystrophy, and new approval in Japan. These developments highlight the company's continued progress and innovation in gene therapy, reinforcing investor confidence amidst market growth. We've identified 2 weaknesses for Sarepta Therapeutics (1 is a bit concerning) that you should be aware of. Diversify your portfolio with solid dividend payers offering reliable income streams to weather potential market turbulence. Recent developments for Sarepta Therapeutics have sparked a positive response in short-term share price, primarily driven by advancements in their gene therapy programs. These innovations, particularly the FDA's designation and updates on the ELEVIDYS program, are poised to bolster investor confidence. However, despite this optimism, it's essential to acknowledge that Sarepta's shares have experienced a 37.80% decline over the past three years, highlighting challenges the company has faced. Relative to the biotechnology industry, Sarepta has underperformed in the past year compared to the US Biotechs market, which returned -9.3%. The recent announcements could potentially impact Sarepta's revenue and earnings forecasts considerably. Analysts project a significant annual revenue increase over the next three years, with expectations that profit margins will improve. Crucially, these updates could address operational delays and safety concerns surrounding ELEVIDYS, enhancing the therapy's credibility and market uptake. In terms of valuation, Sarepta's recent share price movements are in the context of an analyst price target of US$89.96, indicating further room for growth if the company's strategic objectives translate into financial success. These factors collectively shape a complex but promising outlook for Sarepta as it navigates both opportunities and challenges in its field. The valuation report we've compiled suggests that Sarepta Therapeutics' current price could be quite moderate. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include NasdaqGS:SRPT. This article was originally published by Simply Wall St. Have feedback on this article? Concerned about the content? with us directly. Alternatively, email editorial-team@ Sign in to access your portfolio
Business Wire
21-05-2025
- Health
- Business Wire
Sarepta Provides Update on UK Dosing in ENVISION Study of ELEVIDYS for the treatment of Duchenne Muscular Dystrophy
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, shared the following update related to ELEVIDYS (delandistrogene moxeparvovec-rokl), the only approved gene therapy for patients with Duchenne muscular dystrophy. We have received feedback from the Medicines & Healthcare products Regulatory Agency (MHRA) in the United Kingdom (U.K.) that dosing may continue uninterrupted in ENVISION, study SRP-9001-303. ENVISION is a global, randomized, double-blind, placebo-controlled Phase 3 study of ELEVIDYS in non-ambulatory and older ambulatory individuals with Duchenne. ELEVIDYS (delandistrogene moxeparvovec-rokl) is a single-dose, adeno-associated virus (AAV)-based gene transfer therapy for intravenous infusion designed to address the underlying genetic cause of Duchenne muscular dystrophy – mutations or changes in the DMD gene that result in the lack of dystrophin protein – through the delivery of a transgene that codes for the targeted production of ELEVIDYS micro-dystrophin in skeletal muscle. In the U.S., ELEVIDYS is indicated for the treatment of Duchenne muscular dystrophy (DMD) in individuals at least 4 years of age. For patients who are ambulatory and have a confirmed mutation in the DMD gene For patients who are non-ambulatory and have a confirmed mutation in the DMD gene. The DMD indication in non-ambulatory patients is approved under accelerated approval based on expression of ELEVIDYS micro-dystrophin in skeletal muscle. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). IMPORTANT SAFETY INFORMATION CONTRAINDICATION: ELEVIDYS is contraindicated in patients with any deletion in exon 8 and/or exon 9 in the DMD gene. WARNINGS AND PRECAUTIONS: Infusion-related Reactions: Infusion-related reactions, including hypersensitivity reactions and anaphylaxis, have occurred during or up to several hours following ELEVIDYS administration. Closely monitor patients during administration and for at least 3 hours after the end of infusion. If symptoms of infusion-related reactions occur, slow, or stop the infusion and give appropriate treatment. Once symptoms resolve, the infusion may be restarted at a lower rate. ELEVIDYS should be administered in a setting where treatment for infusion-related reactions is immediately available. Discontinue infusion for anaphylaxis. Acute Serious Liver Injury: Acute serious liver injury has been observed with ELEVIDYS, and administration may result in elevations of liver enzymes (such as GGT, GLDH, ALT, AST) or total bilirubin, typically seen within 8 weeks. Patients with preexisting liver impairment, chronic hepatic condition, or acute liver disease (e.g., acute hepatic viral infection) may be at higher risk of acute serious liver injury. Postpone ELEVIDYS administration in patients with acute liver disease until resolved or controlled. Prior to ELEVIDYS administration, perform liver enzyme test and monitor liver function (clinical exam, GGT, and total bilirubin) weekly for the first 3 months following ELEVIDYS infusion. Continue monitoring if clinically indicated, until results are unremarkable (normal clinical exam, GGT, and total bilirubin levels return to near baseline levels). Systemic corticosteroid treatment is recommended for patients before and after ELEVIDYS infusion. Adjust corticosteroid regimen when indicated. If acute serious liver injury is suspected, consultation with a specialist is recommended. Immune-mediated Myositis: In clinical trials, immune-mediated myositis has been observed approximately 1 month following ELEVIDYS infusion in patients with deletion mutations involving exon 8 and/or exon 9 in the DMD gene. Symptoms of severe muscle weakness, including dysphagia, dyspnea, and hypophonia, were observed. Limited data are available for ELEVIDYS treatment in patients with mutations in the DMD gene in exons 1 to 17 and/or exons 59 to 71. Patients with deletions in these regions may be at risk for a severe immune-mediated myositis reaction. Advise patients to contact a physician immediately if they experience any unexplained increased muscle pain, tenderness, or weakness, including dysphagia, dyspnea, or hypophonia, as these may be symptoms of myositis. Consider additional immunomodulatory treatment (immunosuppressants [e.g., calcineurin-inhibitor] in addition to corticosteroids) based on patient's clinical presentation and medical history if these symptoms occur. Myocarditis: Acute serious myocarditis and troponin-I elevations have been observed following ELEVIDYS infusion in clinical trials. If a patient experiences myocarditis, those with pre-existing left ventricle ejection fraction (LVEF) impairment may be at higher risk of adverse outcomes. Monitor troponin-I before ELEVIDYS infusion and weekly for the first month following infusion and continue monitoring if clinically indicated. More frequent monitoring may be warranted in the presence of cardiac symptoms, such as chest pain or shortness of breath. Advise patients to contact a physician immediately if they experience cardiac symptoms. Preexisting Immunity against AAVrh74: In AAV-vector based gene therapies, preexisting anti-AAV antibodies may impede transgene expression at desired therapeutic levels. Following treatment with ELEVIDYS, all patients developed anti-AAVrh74 antibodies. Perform baseline testing for presence of anti-AAVrh74 total binding antibodies prior to ELEVIDYS administration. ELEVIDYS administration is not recommended in patients with elevated anti-AAVrh74 total binding antibody titers greater than or equal to 1:400. Adverse Reactions: The most common adverse reactions (incidence ≥5%) reported in clinical studies were vomiting, nausea, liver injury, pyrexia, and thrombocytopenia. Report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. You may also report side effects to Sarepta Therapeutics at 1-888-SAREPTA (1-888-727-3782). For further information, please see the full Prescribing Information. About Sarepta Therapeutics Sarepta is on an urgent mission: engineer precision genetic medicine for rare diseases that devastate lives and cut futures short. We hold leadership positions in Duchenne muscular dystrophy (Duchenne) and limb-girdle muscular dystrophies (LGMDs) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. For more information, please visit or follow us on LinkedIn, X, Instagram and Facebook. Internet Posting of Information We routinely post information that may be important to investors in the 'For Investors' section of our website at We encourage investors and potential investors to consult our website regularly for important information about us. Forward-Looking Statements This statement contains 'forward-looking statements.' Any statements that are not statements of historical fact may be deemed to be forward-looking statements. Words such as 'believe,' 'anticipate,' 'plan,' 'expect,' 'will,' 'may,' 'intend,' 'prepare,' 'look,' 'potential,' 'possible' and similar expressions are intended to identify forward-looking statements. These forward-looking statements include, without limitation, statements relating to our future operations, research and development programs, and clinical trials. Actual results could materially differ from those stated or implied by these forward-looking statements as a result of such risks and uncertainties. Known risk factors include the following: our products or product candidates may be perceived as insufficiently effective, unsafe or may result in unforeseen adverse events; our products or product candidates may cause undesirable side effects that result in significant negative consequences following any marketing approval; and those risks identified under the heading 'Risk Factors' in our most recent Annual Report on Form 10-K for the year ended December 31, 2024 filed with the Securities and Exchange Commission (SEC) as well as other SEC filings made by the Company, which you are encouraged to review. Any of the foregoing risks could materially and adversely affect the Company's business, results of operations and the trading price of Sarepta's common stock. For a detailed description of risks and uncertainties Sarepta faces, you are encouraged to review the SEC filings made by Sarepta. We caution investors not to place considerable reliance on the forward-looking statements contained herein. Sarepta does not undertake any obligation to publicly update its forward-looking statements based on events or circumstances after the date hereof, except as required by law.
Yahoo
21-05-2025
- Health
- Yahoo
Sarepta Provides Update on UK Dosing in ENVISION Study of ELEVIDYS for the treatment of Duchenne Muscular Dystrophy
CAMBRIDGE, Mass., May 21, 2025--(BUSINESS WIRE)--Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, shared the following update related to ELEVIDYS (delandistrogene moxeparvovec-rokl), the only approved gene therapy for patients with Duchenne muscular dystrophy. We have received feedback from the Medicines & Healthcare products Regulatory Agency (MHRA) in the United Kingdom (U.K.) that dosing may continue uninterrupted in ENVISION, study SRP-9001-303. ENVISION is a global, randomized, double-blind, placebo-controlled Phase 3 study of ELEVIDYS in non-ambulatory and older ambulatory individuals with Duchenne. About ELEVIDYS (delandistrogene moxeparvovec-rokl) ELEVIDYS (delandistrogene moxeparvovec-rokl) is a single-dose, adeno-associated virus (AAV)-based gene transfer therapy for intravenous infusion designed to address the underlying genetic cause of Duchenne muscular dystrophy – mutations or changes in the DMD gene that result in the lack of dystrophin protein – through the delivery of a transgene that codes for the targeted production of ELEVIDYS micro-dystrophin in skeletal muscle. In the U.S., ELEVIDYS is indicated for the treatment of Duchenne muscular dystrophy (DMD) in individuals at least 4 years of age. For patients who are ambulatory and have a confirmed mutation in the DMD gene For patients who are non-ambulatory and have a confirmed mutation in the DMD gene. The DMD indication in non-ambulatory patients is approved under accelerated approval based on expression of ELEVIDYS micro-dystrophin in skeletal muscle. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). IMPORTANT SAFETY INFORMATION CONTRAINDICATION: ELEVIDYS is contraindicated in patients with any deletion in exon 8 and/or exon 9 in the DMD gene. WARNINGS AND PRECAUTIONS: Infusion-related Reactions: Infusion-related reactions, including hypersensitivity reactions and anaphylaxis, have occurred during or up to several hours following ELEVIDYS administration. Closely monitor patients during administration and for at least 3 hours after the end of infusion. If symptoms of infusion-related reactions occur, slow, or stop the infusion and give appropriate treatment. Once symptoms resolve, the infusion may be restarted at a lower rate. ELEVIDYS should be administered in a setting where treatment for infusion-related reactions is immediately available. Discontinue infusion for anaphylaxis. Acute Serious Liver Injury: Acute serious liver injury has been observed with ELEVIDYS, and administration may result in elevations of liver enzymes (such as GGT, GLDH, ALT, AST) or total bilirubin, typically seen within 8 weeks. Patients with preexisting liver impairment, chronic hepatic condition, or acute liver disease (e.g., acute hepatic viral infection) may be at higher risk of acute serious liver injury. Postpone ELEVIDYS administration in patients with acute liver disease until resolved or controlled. Prior to ELEVIDYS administration, perform liver enzyme test and monitor liver function (clinical exam, GGT, and total bilirubin) weekly for the first 3 months following ELEVIDYS infusion. Continue monitoring if clinically indicated, until results are unremarkable (normal clinical exam, GGT, and total bilirubin levels return to near baseline levels). Systemic corticosteroid treatment is recommended for patients before and after ELEVIDYS infusion. Adjust corticosteroid regimen when indicated. If acute serious liver injury is suspected, consultation with a specialist is recommended. Immune-mediated Myositis: In clinical trials, immune-mediated myositis has been observed approximately 1 month following ELEVIDYS infusion in patients with deletion mutations involving exon 8 and/or exon 9 in the DMD gene. Symptoms of severe muscle weakness, including dysphagia, dyspnea, and hypophonia, were observed. Limited data are available for ELEVIDYS treatment in patients with mutations in the DMD gene in exons 1 to 17 and/or exons 59 to 71. Patients with deletions in these regions may be at risk for a severe immune-mediated myositis reaction. Advise patients to contact a physician immediately if they experience any unexplained increased muscle pain, tenderness, or weakness, including dysphagia, dyspnea, or hypophonia, as these may be symptoms of myositis. Consider additional immunomodulatory treatment (immunosuppressants [e.g., calcineurin-inhibitor] in addition to corticosteroids) based on patient's clinical presentation and medical history if these symptoms occur. Myocarditis: Acute serious myocarditis and troponin-I elevations have been observed following ELEVIDYS infusion in clinical trials. If a patient experiences myocarditis, those with pre-existing left ventricle ejection fraction (LVEF) impairment may be at higher risk of adverse outcomes. Monitor troponin-I before ELEVIDYS infusion and weekly for the first month following infusion and continue monitoring if clinically indicated. More frequent monitoring may be warranted in the presence of cardiac symptoms, such as chest pain or shortness of breath. Advise patients to contact a physician immediately if they experience cardiac symptoms. Preexisting Immunity against AAVrh74: In AAV-vector based gene therapies, preexisting anti-AAV antibodies may impede transgene expression at desired therapeutic levels. Following treatment with ELEVIDYS, all patients developed anti-AAVrh74 antibodies. Perform baseline testing for presence of anti-AAVrh74 total binding antibodies prior to ELEVIDYS administration. ELEVIDYS administration is not recommended in patients with elevated anti-AAVrh74 total binding antibody titers greater than or equal to 1:400. Adverse Reactions: The most common adverse reactions (incidence ≥5%) reported in clinical studies were vomiting, nausea, liver injury, pyrexia, and thrombocytopenia. Report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. You may also report side effects to Sarepta Therapeutics at 1-888-SAREPTA (1-888-727-3782). For further information, please see the full Prescribing Information. About Sarepta Therapeutics Sarepta is on an urgent mission: engineer precision genetic medicine for rare diseases that devastate lives and cut futures short. We hold leadership positions in Duchenne muscular dystrophy (Duchenne) and limb-girdle muscular dystrophies (LGMDs) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. For more information, please visit or follow us on LinkedIn, X, Instagram and Facebook. Internet Posting of Information We routinely post information that may be important to investors in the 'For Investors' section of our website at We encourage investors and potential investors to consult our website regularly for important information about us. Forward-Looking Statements This statement contains "forward-looking statements." Any statements that are not statements of historical fact may be deemed to be forward-looking statements. Words such as "believe," "anticipate," "plan," "expect," "will," "may," "intend," "prepare," "look," "potential," "possible" and similar expressions are intended to identify forward-looking statements. These forward-looking statements include, without limitation, statements relating to our future operations, research and development programs, and clinical trials. Actual results could materially differ from those stated or implied by these forward-looking statements as a result of such risks and uncertainties. Known risk factors include the following: our products or product candidates may be perceived as insufficiently effective, unsafe or may result in unforeseen adverse events; our products or product candidates may cause undesirable side effects that result in significant negative consequences following any marketing approval; and those risks identified under the heading "Risk Factors" in our most recent Annual Report on Form 10-K for the year ended December 31, 2024 filed with the Securities and Exchange Commission (SEC) as well as other SEC filings made by the Company, which you are encouraged to review. Any of the foregoing risks could materially and adversely affect the Company's business, results of operations and the trading price of Sarepta's common stock. For a detailed description of risks and uncertainties Sarepta faces, you are encouraged to review the SEC filings made by Sarepta. We caution investors not to place considerable reliance on the forward-looking statements contained herein. Sarepta does not undertake any obligation to publicly update its forward-looking statements based on events or circumstances after the date hereof, except as required by law. View source version on Contacts Investor Contact: Ian Estepan617-274-4052iestepan@ Media Contacts: Tracy Sorrentino617-301-8566tsorrentino@ Kara Hoeger617-710-3898KHoeger@ 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
Yahoo
20-05-2025
- Business
- Yahoo
SRPT Q1 Earnings Call: Sarepta Adjusts Guidance After Safety Event and Administrative Delays
Biotech company Sarepta Therapeutics (NASDAQ:SRPT) reported Q1 CY2025 results beating Wall Street's revenue expectations , with sales up 80.2% year on year to $744.9 million. Its non-GAAP loss of $3.42 per share was significantly below analysts' consensus estimates. Is now the time to buy SRPT? Find out in our full research report (it's free). Revenue: $744.9 million vs analyst estimates of $693.5 million (80.2% year-on-year growth, 7.4% beat) Adjusted EPS: -$3.42 vs analyst estimates of -$0.65 (significant miss) Adjusted EBITDA: -$239.6 million vs analyst estimates of -$371 million (-32.2% margin, 35.4% beat) Operating Margin: -40.3%, down from 8.4% in the same quarter last year Free Cash Flow was -$627.1 million compared to -$274.5 million in the same quarter last year Market Capitalization: $3.58 billion Sarepta Therapeutics' first quarter results were shaped by significant growth in its gene therapy and exon-skipping product lines, but management acknowledged that the period was marked by operational and clinical challenges. CEO Doug Ingram highlighted that while the company treated more patients with ELEVIDYS—its Duchenne muscular dystrophy gene therapy—than ever before, administrative hurdles, site imbalances, and a recent safety event led to a more cautious outlook for the rest of the year. Looking ahead, management cited three main factors behind its revised annual guidance: the need for extensive educational outreach following a patient death related to ELEVIDYS, slower administrative processing times for gene therapy infusions, and a concentration of demand at top treatment sites nearing capacity. Ingram stated, 'We are changing our net product revenue guidance…driven by three factors,' emphasizing that these are expected to impact both timing and volume of infusions in 2025. As Sarepta navigated a complex quarter, management detailed several operational and strategic developments tied to product performance and the company's evolving market approach. The quarter's results were primarily influenced by events in gene therapy delivery, site operations, and ongoing safety monitoring. ELEVIDYS Uptake and Challenges: Management reported a sharp increase in ELEVIDYS usage, but noted that a patient death from acute liver failure led some families to delay infusions while seeking more information about the therapy's safety profile. Administrative Process Delays: The company cited a longer-than-expected timeframe from patient enrollment to infusion, particularly due to complex paperwork, insurance agreements, and scheduling bottlenecks at certain centers. Specific issues, such as delays with Medi-Cal in California, have since been addressed. Site Utilization Imbalance: Roughly 60% of ELEVIDYS revenue came from a handful of leading treatment sites, many now booked up to a year in advance. Sarepta aims to engage secondary sites to better distribute patient volume and reduce wait times. Proactive Educational Outreach: Management launched comprehensive outreach efforts targeting both physicians and patients, including direct-to-consumer campaigns and digital resources, to address safety concerns and expedite access to therapy. Pipeline and Research Momentum: Beyond ELEVIDYS, Sarepta advanced its limb-girdle muscular dystrophy (LGMD) and siRNA programs, with expectations to submit a biologics license application for its EMERGENE therapy in the second half of the year and share new data from ongoing studies. Looking to the remainder of 2025, management's outlook centers on resolving operational hurdles and rebuilding momentum for ELEVIDYS, while expanding access and maintaining investment in R&D. Broader Site Engagement: Sarepta plans to intensify support for secondary infusion centers, aiming to alleviate the backlog at top sites and improve overall patient access to ELEVIDYS. Educational Initiatives: Management believes that ongoing education of both healthcare providers and patient families about the safety and efficacy data will be critical to restoring confidence and driving new treatment initiations. Pipeline Readouts and Regulatory Milestones: Sarepta anticipates key data releases and regulatory filings, particularly in its LGMD and siRNA programs, which management expects will underpin future revenue and diversify the company's therapeutic base. Tazeen Ahmad (Bank of America Securities): Asked which factor—site capacity, administrative complexity, or the safety event—most heavily influenced revised guidance. Management cited cycle times as the principal mechanical driver, with all three contributing. Ritu Baral (TD Cowen): Inquired how Sarepta plans to direct patients to less-utilized centers and whether more sites might open. CEO Doug Ingram stated the focus will be on expanding engagement and education at existing secondary sites rather than increasing the total number. Louise Chen (Scotiabank): Queried whether the guidance revision was entirely ELEVIDYS-related and about anticipated sales trends. Management confirmed the adjustment was due to ELEVIDYS and expects demand to recover in the summer and back half of the year. Andrew Tsai (Jefferies): Questioned the risk of more severe regulatory actions, such as product withdrawal, following the safety event. Management emphasized ELEVIDYS' risk-benefit profile and ongoing regulatory support. Eliana Merle (UBS): Sought clarity on potential label updates for ELEVIDYS after the patient death. Sarepta stated a supplement had been filed with the FDA, with a review expected by year-end. In upcoming quarters, the StockStory team will monitor (1) Sarepta's progress in expanding ELEVIDYS capacity at secondary sites, (2) the impact of educational initiatives on therapy adoption following recent safety concerns, and (3) the timing and outcomes of key clinical and regulatory milestones in the LGMD and siRNA pipelines. Continued resolution of administrative bottlenecks will also be closely watched as an indicator of operational improvement. Sarepta Therapeutics currently trades at a forward P/E ratio of 3.6×. In the wake of earnings, is it a buy or sell? The answer lies in our free research report. The market surged in 2024 and reached record highs after Donald Trump's presidential victory in November, but questions about new economic policies are adding much uncertainty for 2025. While the crowd speculates what might happen next, we're homing in on the companies that can succeed regardless of the political or macroeconomic environment. 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