Sarepta Therapeutics, Inc.
215 First Street
Cambridge, MA -2142
United States
882 articles about Sarepta Therapeutics, Inc.
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In 2023, the FDA greenlit 55 new drugs and 34 cell and gene therapies. Follow along as BioSpace keeps you up to date on all of the FDA's decisions in 2024.
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Sarepta Therapeutics to Present at Upcoming Investor Conferences - March 4, 2024
3/4/2024
Sarepta Therapeutics, Inc. today announced that senior management will participate in fireside chats at two upcoming investor conferences.
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The annual observance highlights how far the industry has come and serves as a wake-up call for how far it must still go to meet the needs of patients with rare diseases.
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Sarepta Therapeutics Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) - February 29, 2024
2/29/2024
Sarepta Therapeutics, Inc., 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.
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Sarepta Therapeutics on Wednesday called the launch of the gene therapy for Duchenne muscular dystrophy “exceptional” but the company does not expect to see significant growth in the first half of 2024 due to its currently limited patient pool.
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Sarepta Therapeutics Announces Fourth Quarter and Full-Year 2023 Financial Results and Recent Corporate Developments
2/28/2024
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 2023.
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Sarepta Therapeutics to Announce Fourth Quarter and Full-Year 2023 Financial Results
2/21/2024
Sarepta Therapeutics, Inc. will report fourth quarter and full-year 2023 financial results after the Nasdaq Global Market closes on Wednesday, Feb. 28, 2024.
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Sarepta Therapeutics Announces U.S. FDA Acceptance of an Efficacy Supplement to Expand the ELEVIDYS Indication
2/16/2024
Sarepta Therapeutics, Inc., the leader in precision genetic medicine for rare diseases, announced the U.S. Food and Drug Administration has accepted and filed the Company's efficacy supplement to the Biologics License Application for ELEVIDYS .
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The regulator has granted a priority review of the efficacy supplement for Sarepta Therapeutics’ gene therapy Elevidys with a target decision date of June 21, 2024.
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Gene therapy company Sarepta Therapeutics provided additional data for SRP-5051 in treating Duchenne muscular dystrophy patients who are amenable to exon 51 skipping.
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Sarepta Therapeutics Announces Positive Data from Part B of MOMENTUM, a Phase 2 Study of SRP-5051 in Patients with Duchenne Muscular Dystrophy Amenable to Skipping Exon 51
1/29/2024
Sarepta Therapeutics, Inc. today announced positive data from Part B of the MOMENTUM study (Study SRP-5051-201), a global, Phase 2, multi-ascending dose clinical trial of SRP-5051 (vesleteplirsen) that enrolled patients aged 8 to 21 years.
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Sarepta Therapeutics Initiates Screening in EMERGENE, a Phase 3 Clinical Study of SRP-9003 for the Treatment of Limb-Girdle Muscular Dystrophy Type 2E/R4
1/16/2024
Sarepta Therapeutics, Inc. today announced that screening is underway in Study SRP-9003-301.
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Sarepta Therapeutics Reports Preliminary* Fourth Quarter and Full-Year 2023 Net Product Revenue
1/8/2024
Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today reported preliminary* fourth quarter and full-year 2023 net product revenue and cash on hand as of December 31, 2023, as part of its presentation today at the 42nd Annual J.P. Morgan Healthcare Conference in San Francisco, Calif.
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Sarepta Therapeutics to Present at the 42nd Annual J.P. Morgan Healthcare Conference
1/2/2024
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.
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Sarepta Therapeutics Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) - December 29, 2023
12/29/2023
Sarepta Therapeutics, Inc. 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 2023.
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Sarepta Therapeutics Submits Efficacy Supplement to Expand the ELEVIDYS Label to include Duchenne Muscular Dystrophy Patients without Restriction to Age or Ambulatory Status
12/22/2023
Sarepta Therapeutics, Inc. (NASDAQ:SRPT) today announced submission of an efficacy supplement to the Biologics License Application (BLA) for ELEVIDYS (delandistrogene moxeparvovec-rokl) to expand its labeled indication as follows “[ELEVIDYS is indicated for] the treatment of Duchenne muscular dystrophy (DMD) patients with a confirmed mutation in the DMD gene.”
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Recent FDA approvals of novel drugs based on less-than-stellar clinical evidence point to a trend toward regulatory flexibility—particularly in indications with very high unmet need.
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Sarepta Therapeutics Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) - November 30, 2023
11/30/2023
Sarepta Therapeutics, Inc., 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 2023.
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Sarepta Therapeutics to Present at the UBS Biopharma Conference
11/2/2023
Sarepta Therapeutics, Inc. 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.
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Sarepta Therapeutics Announces Third Quarter 2023 Financial Results and Recent Corporate Developments
11/1/2023
Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today reported financial results for the third quarter 2023.