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. develops and commercializes precision genetic medicines for rare diseases, with a central focus on Duchenne muscular dystrophy and other neuromuscular conditions. Company news commonly covers product revenue and commercialization trends for ELEVIDYS and PMO therapies, including AMONDYS 45, VYONDYS 53 and EXONDYS 51.
Updates also address FDA interactions for Duchenne therapies, clinical and biomarker data from the siRNA pipeline, and programs such as SRP-1001 for FSHD1 and SRP-1003 for DM1. Other recurring announcements include quarterly financial results, Nasdaq inducement equity grants, and patient-community initiatives tied to Duchenne muscular dystrophy.
AavantiBio, a new gene therapy company, has secured $107 million in Series A financing led by notable life sciences investors, including Sarepta Therapeutics (NASDAQ: SRPT), which contributed $15 million. The company, co-founded by experts Barry Byrne and Manuela Corti, will focus on developing therapies for Friedreich's Ataxia, a rare genetic disorder affecting the nervous system and heart. Bo Cumbo, formerly Sarepta's CCO, has been appointed CEO. AavantiBio aims to leverage its connections with the University of Florida’s Powell Gene Therapy Center to enhance its research capabilities.
Sarepta Therapeutics (NASDAQ: SRPT) announced the 21 recipients of Route 79, The Duchenne Scholarship Program, aiding students with Duchenne muscular dystrophy in pursuing higher education. Each recipient receives up to $5,000, showcasing their community involvement and personal achievements. This is the third year of the program, reflecting Sarepta's commitment to supporting the Duchenne community, especially amid challenges posed by COVID-19. The selection process is overseen by an independent committee to ensure fairness and anonymity in evaluating applicants.
Sarepta Therapeutics (NASDAQ: SRPT) announced the completion of a Type C meeting with the FDA's OTAT regarding the clinical trial for SRP-9001, a gene transfer therapy for Duchenne muscular dystrophy (DMD). The FDA requested additional potency assays for the commercial process material prior to the clinical study. Sarepta believes it has existing data that may satisfy this request but needs further discussions with the FDA to confirm.
The company remains committed to advancing SRP-9001, which is designed to deliver a micro-dystrophin-encoding gene to muscle tissue, with potential transformative effects for DMD patients.
Sarepta Therapeutics (NASDAQ:SRPT) announced the granting of equity awards to 20 new employees on August 31, 2020, in accordance with its 2014 Employment Commencement Incentive Plan. The awards include options for 17,310 shares and 6,655 restricted stock units (RSUs). The options have an exercise price of $146.42 per share, matching the closing stock price on the grant date. Vesting for options occurs quarterly over four years, while RSUs vest annually over the same period, contingent on continued employment.
Sarepta Therapeutics announced that the FDA has accepted its New Drug Application for casimersen (SRP-4045), seeking accelerated approval for treating Duchenne muscular dystrophy (DMD) in patients with exon 45 amenable mutations.
The FDA granted Priority Review Status with a regulatory action date set for February 25, 2021. Additionally, casimersen received conditional approval for the brand name AMONDYS 45. The application includes data from the ESSENCE study, demonstrating significant dystrophin production increases in treated patients compared to placebo.
Sarepta Therapeutics (NASDAQ: SRPT) has announced a strategic collaboration with the University of Florida to advance research in genetic medicines. This partnership aims to fund multiple research projects, enabling Sarepta to exclusively develop any therapeutic compounds that emerge. The collaboration focuses on innovative gene therapy vectors and gene editing technologies, targeting rare genetic diseases. By leveraging the expertise of UF researchers, Sarepta aims to foster advancements that could significantly improve patient outcomes in rare genetic disorders.
Sarepta Therapeutics (NASDAQ:SRPT) announced the granting of equity awards to 20 new employees as an inducement to their employment on July 31, 2020. The awards included options to purchase 24,230 shares and 12,145 restricted stock units (RSUs), with an exercise price of $153.52 per share, equating to the stock's closing price on the grant date. Options will vest over four years, with RSUs vesting annually. This initiative aligns with Nasdaq Listing Rule 5635(c)(4) and reflects the company’s commitment to attracting talent in precision genetic medicine for rare diseases.
Sarepta Therapeutics, Inc. (NASDAQ: SRPT) will release its second quarter 2020 financial results on August 5, 2020, post-market. A conference call for investors will follow at 4:30 p.m. E.T. The call will provide insights into the company’s financial performance and updates on its ongoing studies in genetic medicine targeting rare diseases, particularly Duchenne muscular dystrophy. Investors can access the call via phone or through a live webcast on Sarepta's website.
Sarepta Therapeutics (NASDAQ: SRPT) announced the grant of equity awards to 26 newly hired employees on June 30, 2020. This action, approved by the Board of Directors, includes options to purchase 27,315 shares and 13,680 restricted stock units (RSUs). The options are priced at $160.34, reflecting the stock's closing price on the grant date. Vesting for the options occurs over four years, while RSUs vest annually for the same period, contingent on continued employment. Sarepta focuses on developing precision genetic medicine for rare diseases, with over 40 programs in various stages.
Sarepta Therapeutics (NASDAQ:SRPT) announced the retirement of Sandy Mahatme, CFO and CBO, effective July 10, 2020. Under his leadership for nearly eight years, the company underwent significant transformation, enhancing its financial standing and advancing its pipeline in genetic medicine for rare diseases. CEO Doug Ingram acknowledged Mahatme's contributions in building a strong finance team. An interim reporting structure will be established as the company searches for a new CFO. Mahatme will remain on the boards of other therapeutics companies.