Welcome to our dedicated page for Sarepta Therapeutics news (Ticker: SRPT), a resource for investors and traders seeking the latest updates and insights on Sarepta Therapeutics stock.
Sarepta Therapeutics, Inc. (NASDAQ: SRPT) is a biotechnology company focused on precision genetic medicine for rare diseases, with a stated leadership position in Duchenne muscular dystrophy and an expanding portfolio across muscle, central nervous system and cardiac conditions. The SRPT news feed on Stock Titan aggregates company-issued updates and market-moving announcements that reflect Sarepta’s scientific, regulatory and financial developments.
Investors and followers of SRPT can use this page to review earnings and revenue updates, such as preliminary net product revenue reports that break out contributions from ELEVIDYS and the company’s PMO franchise, as well as quarterly financial results and commentary on cash position and capital structure. News items also cover clinical and regulatory milestones, including updates to the ELEVIDYS prescribing information, FDA safety labeling decisions, and the design and progress of studies like ENDEAVOR and ESSENCE.
The feed highlights pipeline progress in Sarepta’s next-generation siRNA platform, including clinical trial applications and early-stage data for programs such as SRP-1003 for myotonic dystrophy type 1 and SRP-1005 for Huntington’s disease. It also captures disclosures about strategic restructuring, clinical holds in limb girdle muscular dystrophy gene therapy programs, and collaborations with partners like Arrowhead Pharmaceuticals.
Corporate and capital markets news—such as convertible note exchanges, private placements of common stock, inducement grants under Nasdaq Listing Rule 5635(c)(4), and investor conference presentations—are also included. By reviewing this consolidated SRPT news stream, users can quickly see how Sarepta communicates its progress in genetic medicine, regulatory interactions, financing activities and strategic priorities over time.
Sarepta Therapeutics announced that the FDA Cellular, Tissue and Gene Therapies Advisory Committee voted 8-6 in favor of accelerated approval for SRP-9001, a gene therapy designed to treat Duchenne muscular dystrophy (DMD). The therapy aims to deliver a gene coding for a shortened, functional form of dystrophin to muscle cells, addressing the underlying cause of DMD.
The committee's decision was based on non-clinical evidence and data from studies 101, 102, and 103, along with an integrated analysis comparing functional results to a propensity-score-weighted external control. While not binding, this vote will be considered by the FDA in its final decision, with a regulatory action date set for May 29, 2023.
SRP-9001 is currently under priority review by the FDA. Sarepta plans to commercialize the therapy in the United States upon approval, while Roche will handle distribution outside the U.S. as part of a partnership formed in December 2019.
Sarepta Therapeutics, Inc. (NASDAQ:SRPT) will release its first quarter 2023 financial results after market close on May 2, 2023. A conference call to discuss these results will be hosted at 4:30 p.m. E.T. The event will be available via webcast on the investor relations section of Sarepta's website.
The company focuses on precision genetic medicine for rare diseases, holding leadership positions in Duchenne muscular dystrophy (DMD) and limb-girdle muscular dystrophies (LGMDs). It boasts a pipeline of over 40 programs in development, driven by its Precision Genetic Medicine Engine employing gene therapy, RNA, and gene editing technologies.
Sarepta Therapeutics (NASDAQ: SRPT) announced the date of the FDA’s Cellular, Tissue and Gene Therapies Advisory Committee meeting for the SRP-9001 biologics license application (BLA) on May 12, 2023. This virtual meeting is critical as it precedes the regulatory action date of May 29, 2023, for the investigational gene therapy targeting Duchenne muscular dystrophy.
CEO Doug Ingram expressed anticipation in showcasing the evidence of SRP-9001’s transformative potential. The therapy aims to deliver functional dystrophin components to muscle tissue, essential for patients suffering from Duchenne muscular dystrophy. Sarepta plans to commercialize SRP-9001 in the U.S. post FDA approval and has partnered with Roche to enhance global access to this promising therapy.
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