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 leader in precision genetic medicine, pioneering RNA-targeted therapies for rare neuromuscular and infectious diseases. This dedicated news hub provides investors and healthcare professionals with essential updates on SRPT's scientific advancements, regulatory milestones, and strategic initiatives.
Access real-time press releases covering clinical trial developments, partnership announcements, and financial disclosures. Our curated news collection simplifies tracking SRPT's progress in bringing transformative treatments to underserved patient populations through its proprietary platform technologies.
Key updates include FDA communications regarding novel therapies, research collaborations advancing genetic medicine, and operational developments impacting SRPT's therapeutic pipeline. All content is verified through primary sources to ensure accuracy and timeliness.
Bookmark this page for streamlined access to Sarepta's latest achievements in exon-skipping therapies and gene editing innovations. Stay informed about critical developments shaping this biopharmaceutical innovator's trajectory in targeted genetic treatments.
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.
Sarepta Therapeutics (NASDAQ: SRPT) announced the completion of a rolling New Drug Application (NDA) to the FDA for casimersen, aimed at treating patients with Duchenne muscular dystrophy (DMD) who have mutations amenable to skipping exon 45. Casimersen represents the third exon-skipping medicine from Sarepta's PMO RNA-based platform. The NDA submission includes data from the ESSENCE Phase 3 study demonstrating significant dystrophin production. If approved, casimersen could potentially treat about 8% of DMD patients, contributing to Sarepta's goal of addressing nearly 30% of this patient population.
Sarepta Therapeutics (NASDAQ: SRPT) has entered a global research and option agreement with Codiak BioSciences to develop engineered exosome therapeutics targeting neuromuscular diseases. The two-year agreement covers five targets, with Codiak eligible for up to $72.5 million in upfront and near-term license payments plus research funding. This collaboration aims to leverage Codiak's exosome technology for gene therapy and RNA delivery, addressing limitations of existing treatments and enhancing precision medicine strategies in this sector.