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Sarepta Therapeutics, Inc. (NASDAQ: SRPT) is a pioneering biopharmaceutical company primarily engaged in the discovery and advancement of RNA-targeted therapeutics. Headquartered in Cambridge, Massachusetts, Sarepta is dedicated to developing innovative treatments for a range of rare, infectious, and other challenging diseases.
Core Focus: Sarepta’s primary focus is on Duchenne Muscular Dystrophy (DMD), a severe type of muscular dystrophy. The company's lead product candidate, eteplirsen, is designed to skip exon 51 and potentially modify the progression of DMD. Alongside eteplirsen, Sarepta is working on other DMD drug candidates that target different exons.
Innovative Technology: The company leverages proprietary RNA-targeted technology platforms to create novel pharmaceuticals. This technology is pivotal in addressing diseases with high unmet medical needs.
Therapeutic Pipeline:
- DMD Program: Focused on rapidly advancing exon-skipping drug candidates.
- Infectious Diseases: Developing treatments for drug-resistant bacteria and other rare infectious diseases.
Financial Condition and Partnerships: Sarepta collaborates with third-party contractors for the manufacturing of its product candidates. This strategic approach allows the company to focus on innovation and development while ensuring efficient production processes. Despite most of its product candidates being in early developmental stages, Sarepta continues to secure funding and partnerships to support its ambitious research and development goals.
For more information, visit their official website at www.sarepta.com.
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.
Sarepta Therapeutics (NASDAQ:SRPT) announced the granting of equity awards to 18 new employees as part of its 2014 Employment Commencement Incentive Plan, approved by the Compensation Committee on March 31, 2023. The awards include options to purchase 11,075 shares of common stock at an exercise price of $137.83 per share, and 5,700 restricted stock units (RSUs). The options will vest over four years, while the RSUs will vest yearly on anniversaries of the grant date. Sarepta focuses on precision genetic medicine aimed at rare diseases, with over 40 programs in development.
Sarepta Therapeutics (NASDAQ:SRPT) announced that the FDA's Office of Therapeutics will hold an advisory committee meeting regarding the SRP-9001 biologics license application (BLA) before the regulatory action date of May 29, 2023. This meeting signifies a shift from previous communications and focuses on evaluating the evidence that SRP-9001 can predict clinical benefits, essential for potential accelerated approval. CEO Doug Ingram expressed readiness to present comprehensive data supporting the therapy's transformative potential. A related conference call is scheduled for 4:30 p.m. ET today.
Sarepta Therapeutics granted equity awards to 19 new employees on February 28, 2023, under its 2014 Employment Commencement Incentive Plan. This was approved by the Compensation Committee according to Nasdaq Listing Rule 5635(c)(4). The awards include options for 20,100 shares of common stock and 11,000 restricted stock units (RSUs). The options have an exercise price of $122.13 per share, equal to the closing stock price on the grant date. The vesting schedule for both options and RSUs spans four years, dependent on continued employment.
Sarepta focuses on precision genetic medicine for rare diseases, holding a leadership role in DMD and LGMD.
Sarepta Therapeutics reported strong financial results for Q4 and full-year 2022, with total revenues of $258.4 million for the quarter and $933.0 million for the year. Net product revenues increased 32% year-over-year in Q4 and 38% for the full year. The company reported a net loss of $109.2 million for Q4 and $703.5 million for the year. The FDA accepted the Biologics License Application for SRP-9001, granting it Priority Review, with an expected decision on May 29, 2023. Sarepta's ongoing commitment to patient care and its pipeline growth, including new gene therapy candidates, positions it strongly in the genetic medicine market.
Sarepta Therapeutics (NASDAQ:SRPT) has launched its Route 79 Duchenne Scholarship Program for the 2023-2024 academic year, accepting applications until May 5, 2023. Scholarships of up to $5,000 will be awarded to 20 individuals diagnosed with Duchenne muscular dystrophy and five siblings. This initiative, now in its sixth year, aims to support educational pursuits for these individuals. Interested applicants must be enrolled in an accredited U.S. college or vocational school. Since 2018, 84 scholarships have been awarded, showcasing Sarepta's commitment to the Duchenne community.
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