Sarepta Therapeutics, Inc.
215 First Street
Cambridge, MA -2142
United States
829 articles with Sarepta Therapeutics, Inc.
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Peter Marks described the steps the agency is taking to advance the development of gene therapies for rare disorders. This could spell good news in the near future for Sarepta Therapeutics.
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The FDA will hold an advisory committee meeting for Sarepta’s investigational gene therapy for Duchenne muscular dystrophy ahead of its May 29, 2023 action date.
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Sarepta Therapeutics Announces Advisory Committee Meeting will be Held for SRP-9001
3/16/2023
Sarepta Therapeutics, Inc. (NASDAQ:SRPT) 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 in advance of the May 29, 2023 regulatory action date.
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Sarepta Therapeutics Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) - February 28, 2023
2/28/2023
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 2023.
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Sarepta Therapeutics Announces Fourth Quarter and Full-Year 2022 Financial Results and Recent Corporate Developments
2/28/2023
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.
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Sarepta Therapeutics Announces Call for Applications for the 6th Annual Route 79, The Duchenne Scholarship Program
2/28/2023
Sarepta Therapeutics, Inc., the leader in precision genetic medicine for rare diseases, announced the official opening of Route 79, The Duchenne Scholarship Program for the 2023-2024 academic year.
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Sarepta Therapeutics to Announce Fourth Quarter and Full-Year 2022 Financial Results
2/21/2023
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 to provide a corporate update.
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Sarepta Therapeutics Announces Initiation of VOYAGENE, a Clinical Study of SRP-9003 for the Treatment of Limb-Girdle Muscular Dystrophy Type 2E/R4
2/17/2023
Sarepta Therapeutics, Inc., the leader in precision genetic medicine for rare diseases, announced that the first patient has been dosed in Study SRP-9003-102.
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Sarepta Therapeutics Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) - Jan 31, 2023
1/31/2023
Sarepta Therapeutics, Inc. 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 2023.
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Sarepta Therapeutics Reports Preliminary* Fourth Quarter and Full-Year 2022 Net Product Revenues
1/9/2023
Sarepta Therapeutics, Inc. reported preliminary* fourth quarter and full-year 2022 net product revenues as part of their presentation today at the 41st Annual J.P. Morgan Healthcare Conference.
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Sarepta and Catalent Expand Strategic Manufacturing Partnership With Commercial Supply Agreement for Duchenne Muscular Dystrophy Gene Therapy Candidate
1/5/2023
Catalent, Inc. and Sarepta Therapeutics, Inc. today announced the signing of a commercial supply agreement for Catalent to manufacture delandistrogene moxeparvovec (SRP-9001), Sarepta’s most advanced gene therapy candidate for the treatment of Duchenne muscular dystrophy (DMD).
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Sarepta Therapeutics to Present at the 41st Annual J.P. Morgan Healthcare Conference
1/3/2023
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.
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Sarepta Therapeutics Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) - December 30, 2022
12/30/2022
Sarepta Therapeutics, Inc., 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 December 2022.
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Sarepta Therapeutics Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) - November 30, 2022
11/30/2022
Sarepta Therapeutics, Inc. granted equity awards on November 30, 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 42 individuals hired by Sarepta in November 2022.
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Sarepta Therapeutics Announces That U.S. FDA has Accepted for Filing and Granted Priority Review for the Biologics License Application for SRP-9001
11/28/2022
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) has accepted the Company's Biologics License Application (BLA) seeking accelerated approval of SRP-9001 (delandistrogene moxeparvovec) for the treatment of ambulant individuals with Duchenne muscular dystrophy.
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The FDA has accepted Sarepta's BLA for the accelerated approval of SRP-9001, an investigational gene therapy for DMD. Roche is responsible for commercialization outside the U.S.
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Sarepta Therapeutics to Present at the Evercore ISI HealthCONx Conference
11/23/2022
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 5th Annual Evercore ISI HealthCONx Conference on Thursday, December 1, 2022 at 2:15 p.m. E.T.
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Hansa Biopharma and partner Sarepta Therapeutics plan to initiate a clinical study with imlifidase as a pre-treatment to Sarepta's SRP-9001 gene therapy in DMD in 2023
11/3/2022
Hansa Biopharma AB announced that its partner Sarepta Therapeutics plans to initiate a clinical study in 2023 to evaluate imlifidase as pre-treatment in patients with Duchenne muscular dystrophy and pre-existing IgG antibodies to the adeno-associated viral vector rh74 to enable safe and effective dosing with SRP-9001.
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Sarepta Therapeutics Announces Third Quarter 2022 Financial Results and Recent Corporate Developments
11/2/2022
Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today reported financial results for the third quarter 2022.
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Sarepta Therapeutics Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) - October 31, 2022
10/31/2022
Sarepta Therapeutics, Inc., the leader in precision genetic medicine for rare diseases, granted equity awards on October 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 34 individuals hired by Sarepta in October 2022.