Approximately 25 non-ambulatory participants will receive sirolimus as part of the regimen in Cohort 8 of the ENDEAVOR study, which is expected to begin before the end of the year The enhanced immunosuppressive regimen is designed to mitigate the risk of acute liver injury (ALI) and acute liver failure (ALF) associated with AAV gene therapy Decisions regarding resuming commercial dosing for this population will be made in... Read More

CAMBRIDGE, Mass. / Nov 24, 2025 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today shared progress in the Phase 1/2 multiple ascending dose (MAD) clinical study of SRP-1003 (formerly ARO-DM1), an investigational small interfering RNA (siRNA) therapeutic for the treatment of type 1 myotonic dystrophy (DM1). Cohorts 1 (1.5 mg/kg) and 2 (3 mg/kg) of the... Read More

CAMBRIDGE, Mass. / Nov 14, 2025 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced an update to the prescribing information for ELEVIDYS (delandistrogene moxeparvovec-rokl), the only approved gene therapy for Duchenne muscular dystrophy (DMD). As previously disclosed, the ELEVIDYS label now includes several key updates, including: A boxed... Read More

Sarepta announces completion of the confirmatory trial commitment for its ultra-rare disease PMO therapies AMONDYS 45 and VYONDYS 53: While the ESSENCE study did not achieve statistical significance on its primary endpoint, results indicate positive and encouraging trends favoring therapy at 96 weeks Sarepta reports that the study was impacted by the COVID-19 pandemic and, when COVID-impacted data is excluded, meaningful... Read More

CAMBRIDGE, Mass. / Oct 27, 2025 / Business Wire / Sarepta Therapeutics, Inc . (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, will report third quarter 2025 financial results after the Nasdaq Global Market closes on Monday, Nov. 3, 2025. Subsequently, at 4:30 p.m. E.T., the Company will host a conference call to discuss its third quarter 2025 financial results and recent corporate developments. The... Read More

CAMBRIDGE, Mass. / Oct 03, 2025 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, will present at the 30 th Annual Congress of the World Muscle Society (WMS) 2025 Congress, taking place Oct. 7-11, 2025, in Vienna, Austria. Sarepta presentations will include results from several studies in the delandistrogene moxeparvovec clinical development program, as... Read More

CAMBRIDGE, Mass. / Sep 30, 2025 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, granted equity awards on September 30, 2025 (the “Grant Date”) that were approved by the Compensation Committee of its Board of Directors under Sarepta’s 2024 Employment Commencement Incentive Plan, as a material inducement to employment to 8 individuals hired by Sarepta in... Read More

Recipients include 20 individuals living with Duchenne and five siblings of individuals living with the condition Now in its 8 th year, program has awarded more than 150 scholarships CAMBRIDGE, Mass. / Sep 05, 2025 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced 25 recipients of Route 79, The Duchenne Scholarship Program, for the... Read More

Sarepta entered into exchange agreements with a limited number of holders of its Convertible Senior Notes due 2027 that will extend maturity to 2030 while also de-levering the balance sheet The transaction further strengthens Sarepta’s capital structure and reflects its proactive approach to managing liabilities CAMBRIDGE, Mass. / Aug 21, 2025 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in... Read More

Safety review leading to dose escalation and achievement of first predetermined enrollment target in Phase 1/2 study of SRP-1003 for DM1 triggers $100 million milestone payment Sarepta sells at least $174 million of Arrowhead common stock for cash proceeds, Arrowhead will redeem $50 million of stock from Sarepta to prefund half of $100 million milestone payment due to Arrowhead CAMBRIDGE, Mass. / Aug 13, 2025 / Business Wire... Read More

ELEVIDYS shipments have resumed for ambulatory individuals living with Duchenne following notification from the U.S. Food and Drug Administration (FDA); continuing to work with FDA on safety labeling process and risk-mitigation approach for non-ambulatory individuals Net product revenues for the second quarter 2025 totaled $513.1 million, a 42% increase over the same quarter of the prior year Previously announced... Read More

CAMBRIDGE, Mass. / Jul 31, 2025 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, will report second quarter 2025 financial results after the Nasdaq Global Market closes on Wednesday, August 6, 2025. As announced on July 16, 2025, the Company will not be hosting a conference call to discuss results at this time. About Sarepta Therapeutics Sarepta is on an... Read More

Company commends FDA for swift and comprehensive review of available information Shipments to sites of care will resume imminently Sarepta and FDA will continue dialogue on next steps in the safety labeling process and risk-mitigation approach for non-ambulatory patients CAMBRIDGE, Mass. / Jul 28, 2025 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases,... Read More

CAMBRIDGE, Mass. / Jul 25, 2025 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today issued the following statement: Just before 6:00 p.m. ET today, the U.S. Food and Drug Administration (FDA) issued a press release announcing an investigation into the death of an eight-year-old Duchenne muscular dystrophy (Duchenne) patient who had received ELEVIDYS... Read More

Partner Roche will continue its dialogue with the European Medicines Agency to explore a potential path forward to make ELEVIDYS available to individuals living with Duchenne muscular dystrophy in the EU ELEVIDYS is the first and only disease-modifying gene therapy for Duchenne CAMBRIDGE, Mass. / Jul 25, 2025 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare... Read More

CAMBRIDGE, Mass. / Jul 21, 2025 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today issued the following statement: Today, 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... Read More

CAMBRIDGE, Mass. / Jul 18, 2025 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today issued the following statement: Shortly after 2:30 p.m. ET today, Sarepta received an informal request from the U.S. Food and Drug Administration (FDA) to voluntarily halt shipment of ELEVIDYS (delandistrogene moxeparvovec), our gene therapy for Duchenne muscular... Read More

After strategic review, Sarepta focuses pipeline on high-impact programs, prioritizing potentially best-in-class siRNA platform assets Strategic restructuring includes reduced operating expenses, delivering approximately $400 million in anticipated annual cost savings, and implementing a 36% workforce reduction of approximately 500 employees Duchenne portfolio continues to deliver stable and robust revenues, with preliminary... Read More

CAMBRIDGE, Mass. / Jun 30, 2025 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, granted equity awards on June 30, 2025 that were previously approved by the Compensation Committee of its Board of Directors under Sarepta’s 2024 Employment Commencement Incentive Plan, as a material inducement to employment to 53 individuals hired by Sarepta in the second... Read More

The Company is developing an enhanced immunosuppressive regimen in consultation with a panel of multi-disciplinary clinical experts and engaging with regulators Shipments of ELEVIDYS for infusions in non-ambulatory patients in commercial setting are suspended until enhanced regimen is approved and in place ENVISION study is paused while seeking a protocol amendment to incorporate additional immunosuppression Sarepta to host... Read More

CAMBRIDGE, Mass. / Jun 04, 2025 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced that the rAAVrh74 viral vector used in the investigational gene therapy SRP-9003 (bidridistrogene xeboparvovec) for the treatment of limb-girdle muscular dystrophy type 2E/R4, has been granted platform technology designation by the U.S. Food & Drug... Read More

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... Read More

Treatment with ELEVIDYS for Duchenne muscular dystrophy resulted in mean protein expression of 93.87% as measured by western blot in study participants (n=6) Safety profile consistent with prior studies of ELEVIDYS and real-world experience CAMBRIDGE, Mass. / May 16, 2025 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today reported new results from... Read More

Significant functional benefits for 8- and 9-year-olds with Duchenne in Part 2 of the EMBARK study, contributing to the evidence of stabilization or slowing of disease progression in later childhood when muscle weakness typically progresses Statistically significant differences were observed on all key endpoints including 4.75 points (P=0.0026) on North Star Ambulatory Assessment (NSAA), 6.87 seconds in time-to-rise (TTR)... Read More

Approval based on efficacy and safety results from clinical studies, including longer-term functional outcomes from EMBARK global phase 3 study Company is eligible to receive up to $103.5M in near-term regulatory and commercial milestone payments CAMBRIDGE, Mass. / May 13, 2025 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced that the... Read More

CAMBRIDGE, Mass. / May 08, 2025 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced that senior management will participate in a fireside chat at the BofA Securities Health Care Conference at the Encore Hotel in Las Vegas, Nev. on Wednesday, May 14, 2025 at 8:40 a.m. P.T./11:40 a.m. E.T. The presentations will be webcast live under the... Read More

Net product revenues for the first quarter 2025 totaled $611.5 million, a 70% increase over the same quarter of the prior year ELEVIDYS net product revenue for the first quarter totaled $375.0 million; Royalty revenue from the sales of ELEVIDYS by Roche for the quarter totaled $4.0 million Revised 2025 total net product revenues guidance to $2.3 to $2.6 billion Meaningfully advanced multiple clinical candidates in... Read More

CAMBRIDGE, Mass. / Apr 22, 2025 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, will report first quarter 2025 financial results after the Nasdaq Global Market closes on Tuesday, May 6, 2025. Subsequently, at 4:30 p.m. E.T., the Company will host a conference call to discuss its first quarter 2025 financial results. The event will be webcast live under... Read More

U.S. FDA has confirmed that screening and dosing may proceed in Study SRP-9005-101 for LGMD2C/R5 Enrollment and dosing completed in Study SRP-9004-102 for LGMD2D/R3 Data expected for SRP-9003 for LGMD2E/R4 by mid-2025 CAMBRIDGE, Mass. / Apr 15, 2025 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today shared updates from its clinical programs focused on... Read More

CAMBRIDGE, Mass. / Apr 04, 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 in patients with Duchenne muscular dystrophy. Following the safety update on acute liver failure that was issued on March 18 , European Union (EU) reference... Read More

CAMBRIDGE, Mass. / Mar 31, 2025 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, granted equity awards on March 31, 2025 that were previously approved by the Compensation Committee of its Board of Directors under Sarepta’s 2024 Employment Commencement Incentive Plan, as a material inducement to employment to 39 individuals hired by Sarepta in the first... Read More

Applications for the 2025-2026 academic year will be accepted until May 30, 2025 Scholarships will be awarded to up to 20 individuals living with Duchenne muscular dystrophy and up to five siblings of individuals living with Duchenne CAMBRIDGE, Mass. / Feb 28, 2025 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced the official opening of... Read More

Net product revenues for the fourth quarter 2024 totaled $638.2 million, a 75% increase over the same quarter of the prior year ELEVIDYS net product revenue for the quarter totaled $384.2 million; Royalty revenue from the sales of ELEVIDYS by Roche for the quarter totaled $4.9 million Achieved GAAP and non-GAAP net income of $159.0 million and $206.0 million for the fourth quarter of 2024, respectively CAMBRIDGE, Mass. / Feb... Read More

Provides non-dilutive financing flexibility and supplements strong balance sheet CAMBRIDGE, Mass. / Feb 14, 2025 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, announced today that it has closed on a $600 million senior secured revolving credit facility with a bank syndicate. "Sarepta's financial strength and the positive outlook for our business... Read More

CAMBRIDGE, Mass. / Feb 12, 2025 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, will report fourth quarter and full-year 2024 financial results after the Nasdaq Global Market closes on Wednesday, Feb. 26, 2025. Subsequently, at 4:30 p.m. E.T., the Company will host a conference call to discuss its fourth quarter and full-year 2024 financial results. The... Read More

Treatment with ELEVIDYS corresponded with increases on the North Star Ambulatory Assessment (NSAA) at one year in crossover patients, while the study remained blinded MRI results at two years in patients treated in Part 1 show minimal muscle pathology progression, aligning closely with observed functional benefits Crossover-treated patients show statistically significant benefits of ELEVIDYS treatment on NSAA, Time to Rise... Read More

Preliminary total net product revenue of $638.2 million for the fourth quarter and $1.79 billion for full-year 2024, exceeding full-year guidance by over $100 million Preliminary ELEVIDYS net product revenue totaled $384.2 million for the fourth quarter, exceeding guidance by over $60 million, and $820.8 million for full-year 2024 Preliminary RNA-based PMO net product revenue for the fourth quarter and full-year of 2024... Read More

CAMBRIDGE, Mass. / Dec 31, 2024 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, granted equity awards on December 31, 2024 (the “Grant Date”) that were previously approved by the Compensation Committee of its Board of Directors under Sarepta’s 2024 Employment Commencement Incentive Plan, as a material inducement to employment to 8 individuals hired by... Read More

Sarepta anticipates filing for accelerated approval of SRP-9003 in 2025 CAMBRIDGE, Mass. / Dec 18, 2024 / Business Wire / Sarepta Therapeutics, Inc . (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced that enrollment and dosing is complete in EMERGENE (Study SRP-9003-301), a Phase 3 clinical trial of SRP-9003 (bidridistrogene xeboparvovec). SRP-9003 is an investigational gene therapy... Read More

CAMBRIDGE, Mass. / Nov 29, 2024 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, granted equity awards on November 29, 2024 (the “Grant Date”) that were previously approved by the Compensation Committee of its Board of Directors under Sarepta’s 2024 Employment Commencement Incentive Plan, as a material inducement to employment to 14 individuals hired by... Read More

Sarepta obtains exclusive worldwide licenses to four clinical-stage and three preclinical-stage programs in muscle, central nervous system, and rare pulmonary disorders, including potential best-in-class siRNA-based treatments for DM1 and FSHD Additionally, Arrowhead and Sarepta have entered into a discovery partnership pursuant to which Sarepta will nominate, and Arrowhead will deliver, IND-ready constructs for six targets... Read More

Net product revenues for the third quarter 2024 totaled $429.8 million, a 39% increase over the same quarter of the prior year ELEVIDYS net product revenue for the quarter totaled $181.0 million; Royalty revenue from the sales of ELEVIDYS by Roche for the quarter totaled $9.5 million Achieved GAAP and non-GAAP net income of $33.6 million and $67.0 million for the third quarter 2024, respectively CAMBRIDGE, Mass. / Nov 06,... Read More

CAMBRIDGE, Mass. / Oct 31, 2024 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, granted equity awards on October 31, 2024 (the “Grant Date”) that were previously approved by the Compensation Committee of its Board of Directors under Sarepta’s 2024 Employment Commencement Incentive Plan, as a material inducement to employment to 15 individuals hired by... Read More

CAMBRIDGE, Mass. / Oct 23, 2024 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, will report third quarter 2024 financial results after the Nasdaq Global Market closes on Wednesday, Nov. 6, 2024. Subsequently, at 4:30 p.m. E.T., the Company will host a conference call to discuss its third quarter 2024 financial results. The event will be webcast live... Read More

CAMBRIDGE, Mass. / Sep 30, 2024 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, granted equity awards on September 30, 2024 (the “Grant Date”) that were previously approved by the Compensation Committee of its Board of Directors under Sarepta’s 2024 Employment Commencement Incentive Plan, as a material inducement to employment to 28 individuals hired by... Read More

CAMBRIDGE, Mass. / Sep 26, 2024 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, will present at the 29 th Annual Congress of the World Muscle Society 2024 Congress (WMS 2024), taking place Oct. 8-12, 2024, in Prague, Czechia. Among the data to be presented are new safety and efficacy results from several studies in the delandistrogene moxeparvovec... Read More

Veteran biopharmaceutical executive from GSK and Eli Lilly brings more than 30 years of experience to Sarepta’s Board CAMBRIDGE, Mass. / Sep 16, 2024 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced the appointment of Deirdre P. Connelly to its Board of Directors. Ms. Connelly is a well-regarded executive with more than 30 years of... Read More

Recipients include 20 individuals living with Duchenne muscular dystrophy and five siblings of individuals living with Duchenne CAMBRIDGE, Mass. / Sep 05, 2024 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced 25 recipients of Route 79, The Duchenne Scholarship Program for the 2024-2025 academic year. Of the academic scholarships, 20 will... Read More

CAMBRIDGE, Mass. / Aug 30, 2024 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, granted equity awards on August 30, 2024 (the “Grant Date”) that were previously approved by the Compensation Committee of its Board of Directors under Sarepta’s 2024 Employment Commencement Incentive Plan, as a material inducement to employment to 20 individuals hired by... Read More

CAMBRIDGE, Mass. / Aug 30, 2024 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced that senior management will participate in a fireside chat at the Morgan Stanley 22 nd Annual Global Healthcare Conference at the New York Marriott Marquis in New York, NY. on Friday, Sept. 6, 2024, at 9:15 a.m. E.T. The presentation will be webcast live under... Read More

Net product revenues for the second quarter 2024 totaled $360.5 million, a 51% increase over the same quarter of the prior year ELEVIDYS net product revenue for the quarter totaled $121.7 million; Royalty revenue from the sales of ELEVIDYS by Roche for the quarter totaled $2.4 million Achieved GAAP net income of $6.5 million for the second quarter 2024 and non-GAAP net income of $46.7 million for the same period Sarepta... Read More

CAMBRIDGE, Mass. / Jul 31, 2024 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, granted equity awards on July 31, 2024 (the “Grant Date”) that were previously approved by the Compensation Committee of its Board of Directors under Sarepta’s 2024 Employment Commencement Incentive Plan, as a material inducement to employment to 19 individuals hired by... Read More

CAMBRIDGE, Mass. / Jul 29, 2024 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, will report second quarter 2024 financial results after the Nasdaq Global Market closes on Wednesday, August 7, 2024. Subsequently, at 4:30 p.m. E.T., the Company will host a conference call to discuss its second quarter 2024 financial results. The event will be webcast live... Read More

CAMBRIDGE, Mass. / Jun 28, 2024 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, granted equity awards on June 28, 2024 that were previously approved by the Compensation Committee of its Board of Directors under Sarepta’s 2024 Employment Commencement Incentive Plan, as a material inducement to employment to 23 individuals hired by Sarepta in June 2024.... Read More

FDA grants traditional approval to ELEVIDYS for ambulatory Duchenne patients FDA grants accelerated approval to ELEVIDYS for non-ambulatory Duchenne patients Sarepta will host an investor conference call on June 21, 2024, at 8:30 a.m. ET CAMBRIDGE, Mass. / Jun 20, 2024 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced U.S. Food and Drug... Read More

CAMBRIDGE, Mass. / May 31, 2024 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, granted equity awards on May 31, 2024 (the “Grant Date”) that were previously approved by the Compensation Committee of its Board of Directors under Sarepta’s 2024 Employment Commencement Incentive Plan, as a material inducement to employment to 9 individuals hired by Sarepta... Read More

TIME recognizes Dr. Mendell’s decades-long contributions in the treatment of neuromuscular disease and the advancement of gene therapy, including the first gene therapy for Duchenne muscular dystrophy CAMBRIDGE, Mass. / May 03, 2024 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced that TIME named renown neuromuscular researcher, physician... Read More

Net product revenues for the first quarter 2024 totaled $359.5 million, a 55% increase over the same quarter of the prior year ELEVIDYS net revenues for the quarter totaled $133.9 million Achieved GAAP Earnings of $36.1 million for the first quarter 2024 and non-GAAP Earnings of $78.2 million for the same period CAMBRIDGE, Mass. / May 01, 2024 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in... Read More

CAMBRIDGE, Mass. / Apr 30, 2024 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, granted equity awards on April 30, 2024 that were previously approved by the Compensation Committee of its Board of Directors under Sarepta’s 2024 Employment Commencement Incentive Plan, as a material inducement to employment to 24 individuals hired by Sarepta in April 2024.... Read More

CAMBRIDGE, Mass. / Apr 24, 2024 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, will report first quarter 2024 financial results after the Nasdaq Global Market closes on Wednesday, May 1, 2024. Subsequently, at 4:30 p.m. E.T., the Company will host a conference call to discuss its first quarter 2024 financial results. The event will be webcast live under... Read More

CAMBRIDGE, Mass. / Mar 29, 2024 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, granted equity awards on March 29, 2024 that were previously approved by the Compensation Committee of its Board of Directors under Sarepta’s 2024 Employment Commencement Incentive Plan, as a material inducement to employment to 8 individuals hired by Sarepta in March 2024.... Read More

CAMBRIDGE, Mass. / Mar 04, 2024 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced that senior management will participate in fireside chats at two upcoming investor conferences: Leerink Partners Global Biopharma Conference on Mon., March 11, 2024, at 10:00 a.m. E.T at the Fontainebleau Hotel in Miami, Fla. Barclays 26th Annual Global... Read More

CAMBRIDGE, Mass. / Feb 29, 2024 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, granted equity awards on Feb. 29, 2024 that were previously approved by the Compensation Committee of its Board of Directors under Sarepta’s 2014 Employment Commencement Incentive Plan, as a material inducement to employment to 5 individuals hired by Sarepta in February 2024.... Read More

Applications for the 2024-2025 academic year will be accepted until May 13, 2024 Scholarships will be awarded to up to 20 individuals living with Duchenne muscular dystrophy and up to five siblings of individuals living with Duchenne CAMBRIDGE, Mass. / Feb 29, 2024 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced the official opening of... Read More

Net product revenues for the fourth quarter 2023 totaled $365.1 million, a 55% increase over the same quarter of the prior year; 2023 net product revenues for the full-year 2023 totaled $1.1 billion, an increase of approximately 36% over the prior year ELEVIDYS revenues for the quarter totaled $131.2 million and for full-year totaled $200.4 million CAMBRIDGE, Mass. / Feb 28, 2024 / Business Wire / Sarepta Therapeutics, Inc.... Read More

CAMBRIDGE, Mass. / Feb 21, 2024 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, will report fourth quarter and full-year 2023 financial results after the Nasdaq Global Market closes on Wednesday, Feb. 28, 2024. Subsequently, at 4:30 p.m. E.T., the Company will host a conference call to discuss its fourth quarter and full-year 2023 financial results and... Read More

Priority review granted, with a review goal date of June 21, 2024 CAMBRIDGE, Mass. / Feb 16, 2024 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced the U.S. Food and Drug Administration (FDA) has accepted and filed the Company's efficacy supplement to the Biologics License Application (BLA) for ELEVIDYS (delandistrogene moxeparvovec-rokl)... Read More

CAMBRIDGE, Mass. / Jan 31, 2024 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, granted equity awards on January 31, 2024 that were previously approved by the Compensation Committee of its Board of Directors under Sarepta’s 2014 Employment Commencement Incentive Plan, as a material inducement to employment to 14 individuals hired by Sarepta in January... Read More

At target dose (~30 mg/kg), SRP-5051 dosed monthly resulted in mean dystrophin expression of 5.17% and mean exon skipping of 11.11% at 28 weeks (n=20) The data support a positive benefit-risk profile for SRP-5051 Sarepta will host a conference call at 8:30 a.m. Eastern time on Jan. 29, 2024 CAMBRIDGE, Mass. / Jan 29, 2024 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for... Read More

CAMBRIDGE, Mass. / Jan 16, 2024 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced that screening is underway in Study SRP-9003-301. Also known as EMERGENE, Study 9003-301 is a Phase 3, multi-national, open-label study of SRP-9003 (bidridistrogene xeboparvovec) for the treatment of limb-girdle muscular dystrophy Type 2E (LGMD2E/R4), or beta... Read More

Preliminary total net product revenue is expected to total $1.145 billion for full-year 2023 Preliminary ELEVIDYS net product revenue is expected to be $131.3 million for the fourth quarter and $200.4 million for full-year 2023, significantly exceeding consensus Preliminary RNA-based PMO net product revenue for the fourth quarter and full-year of 2023 are expected to total $234.3 million and $945.0 million, respectively,... Read More

CAMBRIDGE, Mass. / Jan 02, 2024 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced that senior management will present at the 42nd Annual J.P. Morgan Healthcare Conference in San Francisco, Calif. on Monday, Jan. 8, 2024 at 12:00 p.m. E.T. / 9:00 a.m. P.T. Following the presentation there will be a Q&A session starting at 12:20 p.m. E.T. /... Read More

CAMBRIDGE, Mass. / Dec 29, 2023 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, granted equity awards on December 29, 2023 that were previously approved by the Compensation Committee of its Board of Directors under Sarepta’s 2014 Employment Commencement Incentive Plan, as a material inducement to employment to 4 individuals hired by Sarepta in December... Read More

Application includes request for Priority Review from the US FDA Sarepta has also submitted the EMBARK postmarketing requirement to the FDA seeking conversion of the ELEVIDYS accelerated approval to traditional approval CAMBRIDGE, Mass. / Dec 22, 2023 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced submission of an efficacy supplement to... Read More

CAMBRIDGE, Mass. / Nov 30, 2023 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, granted equity awards on November 30, 2023 that were previously approved by the Compensation Committee of its Board of Directors under Sarepta’s 2014 Employment Commencement Incentive Plan, as a material inducement to employment to 13 individuals hired by Sarepta in November... Read More

CAMBRIDGE, Mass. / Nov 02, 2023 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced that senior management will participate in a fireside chat at the UBS Biopharma Conference on Thursday, Nov. 9, 2023 at 9:00 a.m. E.T. The fireside chat will be held at the Fontainebleau Miami Beach in Miami Beach, Fla. The presentation will be webcast live... Read More

ELEVIDYS net product revenues for the quarter totaled $69.1 million Total revenues, which consist of net product revenues and collaboration revenues, for the third quarter 2023 totaled $331.8 million Net product revenues for the third quarter 2023 totaled $309.3 million, a 49% increase over the same quarter of prior year CAMBRIDGE, Mass. / Nov 01, 2023 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in... Read More

CAMBRIDGE, Mass. / Oct 31, 2023 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, granted equity awards on October 31, 2023 that were previously approved by the Compensation Committee of its Board of Directors under Sarepta’s 2014 Employment Commencement Incentive Plan, as a material inducement to employment to 12 individuals hired by Sarepta in October... Read More

Results support submission of an efficacy supplement to the BLA; US FDA has indicated openness to reviewing the data for label expansion based on the totality of evidence from EMBARK In EMBARK, participants treated with ELEVIDYS (delandistrogene moxeparvovec-rokl) showed an increase on the North Star Ambulatory Assessment, a measure of motor function, compared to placebo-treated patients at 52 weeks, although the primary... Read More

CAMBRIDGE, Mass. / Oct 25, 2023 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, will report third quarter 2023 financial results after the Nasdaq Global Market closes on Wednesday, Nov. 1, 2023. Subsequently, at 4:30 p.m. E.T., the Company will host a conference call to discuss its third quarter 2023 financial results. The event will be webcast live... Read More

CAMBRIDGE, Mass. / Sep 29, 2023 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, granted equity awards on September 29, 2023 that were previously approved by the Compensation Committee of its Board of Directors under Sarepta’s 2014 Employment Commencement Incentive Plan, as a material inducement to employment to 24 individuals hired by Sarepta in... Read More

Recipients include 20 individuals living with Duchenne muscular dystrophy and five siblings of individuals living with Duchenne CAMBRIDGE, Mass. / Sep 07, 2023 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced 25 recipients of Route 79, The Duchenne Scholarship Program for the 2023-2024 academic year. Of the 25 recipients, academic... Read More

CAMBRIDGE, Mass. / Sep 05, 2023 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced that senior management will participate in a fireside chat at the Morgan Stanley 21st Annual Global Healthcare Conference on Monday, Sept. 11, 2023 at 8:40 a.m. E.T. The fireside chat will be held at the Sheraton New York in New York, NY. The presentation will... Read More

CAMBRIDGE, Mass. / Aug 31, 2023 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, granted equity awards on August 31, 2023 that were previously approved by the Compensation Committee of its Board of Directors under Sarepta’s 2014 Employment Commencement Incentive Plan, as a material inducement to employment to 12 individuals hired by Sarepta in August... Read More

Following approval on June 22, the first patient received commercially reimbursed ELEVIDYS (delandistrogene moxeparvovec-rokl), earlier today Total revenues, which consist of net product revenues and collaboration revenues, for the second quarter 2023 totaled $261.2 million Net product revenues for the second quarter 2023 totaled $239.0 million, a 13% increase over the same quarter of prior year CAMBRIDGE, Mass. / Aug 02,... Read More

CAMBRIDGE, Mass. / Jul 31, 2023 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, granted equity awards on July 31, 2023 that were previously approved by the Compensation Committee of its Board of Directors under Sarepta’s 2014 Employment Commencement Incentive Plan, as a material inducement to employment to 19 individuals hired by Sarepta in July 2023.... Read More

CAMBRIDGE, Mass. / Jul 26, 2023 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, will report second quarter 2023 financial results after the Nasdaq Global Market closes on Wednesday, August 2, 2023. Subsequently, at 4:30 p.m. E.T., the Company will host a conference call to discuss its second quarter 2023 financial results. The event will be webcast live... Read More

CAMBRIDGE, Mass. / Jul 05, 2023 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced it had completed the sale of its Rare Pediatric Disease Priority Review Voucher (PRV). Sarepta received a payment of $102 million upon completion of the sale. Sarepta was awarded the PRV following U.S. Food and Drug Administration (FDA) accelerated approval of... Read More

CAMBRIDGE, Mass. / Jul 03, 2023 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced that senior management will participate in a fireside chat at Cowen's 2nd Annual RNA Therapeutics Summit on Monday, July 10, 2023 at 11:00 a.m. E.T. The fireside chat will be held virtually. The presentation will be webcast live under the Events &... Read More

CAMBRIDGE, Mass. / Jun 30, 2023 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, granted equity awards on June 30, 2023 that were previously approved by the Compensation Committee of its Board of Directors under Sarepta’s 2014 Employment Commencement Incentive Plan, as a material inducement to employment to 13 individuals hired by Sarepta in June 2023.... Read More

ELEVIDYS (delandistrogene moxeparvovec-rokl) is approved for the treatment of ambulatory pediatric patients aged 4 through 5 years with Duchenne based on expression of ELEVIDYS micro-dystrophin observed in patients treated with ELEVIDYS ELEVIDYS is a one-time treatment designed to treat the underlying genetic cause of Duchenne... Read More

CAMBRIDGE, Mass. / May 31, 2023 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, granted equity awards on May 31, 2023 that were previously approved by the Compensation Committee of its Board of Directors under Sarepta’s 2014 Employment Commencement Incentive Plan, as a material inducement to employment to 33 individuals hired by Sarepta in May 2023. The... Read More

New regulatory action date is June 22, 2023 CAMBRIDGE, Mass. / May 24, 2023 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ: SRPT), the leader in precision genetic medicine for rare diseases, today provided the following update on the Biologics License Application (BLA) for SRP-9001 (delandistrogene moxeparvovec), which is currently under review for the treatment of ambulant individuals with Duchenne muscular dystrophy... Read More

Advisory committee voted 8-6 in support of accelerated approval of SRP-9001 Regulatory action date is May 29, 2023 CAMBRIDGE, Mass. / May 12, 2023 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ: SRPT), the leader in precision genetic medicine for rare diseases, today announced that the U.S. Food and Drug Administration (FDA) Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC) voted 8 to 6 in support of... Read More

Total revenues, which consist of net product revenues and collaboration revenues, for the first quarter 2023 totaled $253.5 million Net product revenues for the first quarter 2023 totaled $231.5 million, a 23% increase over the same quarter of prior year CAMBRIDGE, Mass. / May 02, 2023 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today reported... Read More

CAMBRIDGE, Mass. / Apr 28, 2023 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, granted equity awards on December 31, 2022 that were previously approved by the Compensation Committee of its Board of Directors under Sarepta’s 2014 Employment Commencement Incentive Plan, as a material inducement to employment to 18 individuals hired by Sarepta in April... Read More

CAMBRIDGE, Mass. / Apr 25, 2023 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, will report first quarter 2023 financial results after the Nasdaq Global Market closes on Tuesday, May 2, 2023. Subsequently, at 4:30 p.m. E.T., the Company will host a conference call to discuss its first quarter 2023 financial results. The event will be webcast live under... Read More

CAMBRIDGE, Mass. / Apr 10, 2023 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced that the date of the U.S. Food and Drug Administration’s Cellular, Tissue and Gene Therapies Advisory Committee meeting for the SRP-9001 (delandistrogene moxeparvovec) biologics license application (BLA) is May 12, 2023. The advisory committee meeting will be... Read More

CAMBRIDGE, Mass. / Mar 31, 2023 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, granted equity awards on March 31, 2023 that were previously approved by the Compensation Committee of its Board of Directors under Sarepta’s 2014 Employment Commencement Incentive Plan, as a material inducement to employment to 18 individuals hired by Sarepta in March 2023.... Read More

CAMBRIDGE, Mass. / Mar 16, 2023 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced that at its late cycle meeting for the SRP-9001 (delandistrogene moxeparvovec) biologics license application (BLA), the U.S. Food and Drug Administration’s Office of Therapeutics (OTP) has determined that an advisory committee meeting will be held for SRP-9001... Read More

CAMBRIDGE, Mass. / Feb 28, 2023 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, granted equity awards on February 28, 2023 that were previously approved by the Compensation Committee of its Board of Directors under Sarepta’s 2014 Employment Commencement Incentive Plan, as a material inducement to employment to 19 individuals hired by Sarepta in February... Read More

CAMBRIDGE, Mass. / Feb 28, 2023 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today reported financial results for the fourth quarter and full-year 2022. “Sarepta’s proven ability to launch Duchenne therapies and effectively serve the Duchenne patient community was once again on display in 2022 as we delivered nearly $236 million and $844 million in... Read More

CAMBRIDGE, Mass. / Feb 28, 2023 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced the official opening of Route 79, The Duchenne Scholarship Program for the 2023-2024 academic year. Academic scholarships of up to $5,000 will be awarded to up to 20 individuals living with Duchenne muscular dystrophy and up to five siblings of individuals... Read More

CAMBRIDGE, Mass. / Feb 21, 2023 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, will report fourth quarter and full year 2022 financial results after the Nasdaq Global Market closes on Tuesday, February 28, 2023. Subsequently, at 4:30 p.m. E.T., the Company will host a conference call to discuss its fourth quarter and full-year 2022 financial results and... Read More

CAMBRIDGE, Mass. / Feb 17, 2023 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced that the first patient has been dosed in Study SRP-9003-102. Also known as VOYAGENE, Study 9003-102 is a phase 1 study of SRP-9003 (bidridistrogene xeboparvovec) for the treatment of limb-girdle muscular dystrophy Type 2E/R4 (LGMD2E). VOYAGENE is a U.S.-only... Read More

CAMBRIDGE, Mass., Jan. 31, 2023 (GLOBE NEWSWIRE) -- Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, granted equity awards on January 31, 2022 that were previously approved by the Compensation Committee of its Board of Directors under Sarepta’s 2014 Employment Commencement Incentive Plan, as a material inducement to employment to 40 individuals hired by Sarepta in January... Read More

The Company expects to exceed 2022 full-year guidance for net product revenues Preliminary net product revenues for the fourth quarter and full-year 2022 are expected to total $235.5 million and $843.3 million, respectively Preliminary year-end 2022 cash balance of approximately $2.0 billion CAMBRIDGE, Mass., Jan. 09, 2023 (GLOBE NEWSWIRE) -- Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine... Read More

CAMBRIDGE, Mass., Jan. 03, 2023 (GLOBE NEWSWIRE) -- Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced that senior management will present at the 41st Annual J.P. Morgan Healthcare Conference in San Francisco, California on Monday, January 9, 2023 at 1:30 p.m. E.T. / 10:30 a.m. P.T. Following the presentation there will be a Q&A session starting at 1:50 p.m.... Read More

CAMBRIDGE, Mass., Dec. 30, 2022 (GLOBE NEWSWIRE) -- Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, granted equity awards on December 31, 2022 that were previously approved by the Compensation Committee of its Board of Directors under Sarepta’s 2014 Employment Commencement Incentive Plan, as a material inducement to employment to 13 individuals hired by Sarepta in... Read More