Japanese drugmaker Nippon Shinyaku infringed a Sarepta patent related to its Duchenne muscular dystrophy (DMD) drug Vyondys 53 and must pay $115.2 million in damages, a Delaware jury said on Friday.
CAMBRIDGE, Mass.--(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 for the treatment of limb-girdle muscular dystrophy Type 2...
New Food and Drug Administration (FDA) guidance on accelerated approval for drugs targeting “serious conditions” appears to be a positive move for rare diseases, analysts at Jefferies believe. The FDA earlier this month published the draft guidance on its policies and procedures for the accelerated approval (AA) pathway for drugs for serious conditions that fulfil an unmet medical need.
CAMBRIDGE, Mass.--(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 indivi...
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced an exclusive global licensing and collaboration agreement with Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR). Sarepta will obtain exclusive global rights to multiple clinical, preclinical, and discovery-stage programs for rare, genetic disease...
Sarepta Therapeutics, Inc. reported Q3 2024 net product revenues of $429.8 million, a 39% year-over-year increase, driven by strong sales of ELEVIDYS and other DMD treatments. The company is advancing SRP-9003 gene therapy for LGMD, with phase 3 study results expected in early 2025 and a potential BLA filing by mid-2025. Despite strong revenues, Sarepta may need to raise additional funds within...
Sarepta Therapeutics, Inc. (NASDAQ:SRPT ) Q3 2024 Earnings Conference Call November 6, 2024 4:30 PM ET Company Participants Mary Jenkins - Associate Director, Investor Relations and Corporate Communications Douglas Ingram - President and Chief Executive Officer Dallan Murray - Executive Vice President and Chief Customer Officer Louise Rodino-Klapac - Executive Vice President, Chief Scientific O...
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today reported financial results for the third quarter 2024. “I am pleased to report another strong quarter of performance, as we posted $429.8 million in net product revenue for the third quarter, a 39% increase over the same quarter of the prior year. Reflec...
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