Welcome to our dedicated page for Scholar Rock Holding news (Ticker: SRRK), a resource for investors and traders seeking the latest updates and insights on Scholar Rock Holding stock.
News about Scholar Rock Holding Corporation (NASDAQ: SRRK) focuses on its progress as a late-stage biopharmaceutical company in neuromuscular diseases, particularly spinal muscular atrophy (SMA). Company announcements highlight clinical, regulatory, financial, and corporate developments tied to its myostatin biology platform and lead investigational therapy, apitegromab.
Investors and followers of SRRK can expect regular updates on the regulatory path for apitegromab, including interactions with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Recent press releases describe a Biologics License Application (BLA) for apitegromab, a Complete Response Letter related to a third-party fill-finish facility, a subsequent Type A meeting with the FDA, and ongoing EMA review of a Marketing Authorisation Application. News items also cover disease awareness and launch readiness activities in the United States and Europe.
Scholar Rock’s news flow also includes clinical trial milestones across its pipeline. Examples include dosing in the Phase 2 OPAL study in infants and toddlers with SMA, plans for the FORGE Phase 2 trial in facioscapulohumeral muscular dystrophy (FSHD), completion of a subcutaneous apitegromab Phase 1 study, and initiation of a Phase 1 trial of SRK-439 in healthy volunteers. These updates provide insight into the company’s broader anti-myostatin program and expansion into additional rare, severe, and debilitating neuromuscular diseases.
Financial and corporate news for SRRK features quarterly financial results, cash runway commentary, equity offerings under at-the-market programs, and inducement equity grants to new employees under the 2022 Inducement Equity Plan. Scholar Rock also issues announcements about participation in major healthcare conferences and investor events. For readers tracking SRRK stock and the company’s evolution as a late-stage biopharmaceutical organization, this news page aggregates these developments in one place.
Scholar Rock (NASDAQ: SRRK) reported significant progress in Q2 2025, highlighted by the FDA's acceptance of apitegromab's BLA under priority review with a PDUFA date of September 22, 2025. The company's lead candidate for spinal muscular atrophy (SMA) also received EMA validation for its Marketing Authorisation Application, with European launch anticipated in 2026.
The company reported positive results from the Phase 2 EMBRAZE trial in obesity, demonstrating significant lean mass preservation with apitegromab during tirzepatide-induced weight loss. Financial results showed a net loss of $110 million ($0.98 per share) for Q2 2025. With $295 million in cash and equivalents, Scholar Rock expects to fund operations into 2027.
Scholar Rock (NASDAQ: SRRK), a late-stage biopharmaceutical company developing apitegromab for spinal muscular atrophy (SMA) and other neuromuscular diseases, will host a conference call to discuss Q2 2025 financial results on August 6, 2025, at 8:00am ET.
Investors can access the call by registering online or dialing 800-715-9871 (domestic) or 646-307-1963 (international) with conference ID 3205013. A webcast replay will be available for approximately 90 days on the company's investor relations website.
Scholar Rock (NASDAQ: SRRK), a late-stage biopharmaceutical company developing apitegromab for spinal muscular atrophy (SMA), has granted inducement equity awards to 6 new employees. The awards include 128,057 stock options at an exercise price of $38.59 and 96,043 restricted stock units.
The awards are part of the Company's 2022 Inducement Equity Plan, designed for new hires. The stock options will vest 25% after one year, with remaining 75% vesting quarterly over three years. Restricted stock units will vest in four equal annual installments, subject to continued employment.
Scholar Rock (NASDAQ: SRRK), a late-stage biopharmaceutical company specializing in developing apitegromab for spinal muscular atrophy (SMA) and other neuromuscular diseases, announced its participation in the upcoming Jefferies Global Healthcare Conference. CEO David L. Hallal and the management team will engage in a fireside chat on June 4 at 3:45 p.m. ET in New York City. The presentation will be accessible via live webcast through Scholar Rock's Investors & Media website section, with replay availability for approximately 90 days.
Scholar Rock (SRRK), a late-stage biopharmaceutical company focused on developing apitegromab for spinal muscular atrophy (SMA), has granted inducement equity awards to 14 new employees. The awards include 60,400 shares in stock options with an exercise price of $32.46 and 45,300 shares in restricted stock units.
The stock options will vest 25% after one year from each employee's start date, with the remaining 75% vesting in 12 quarterly installments. The restricted stock units will vest in four equal annual installments. These awards were granted under the Company's 2022 Inducement Equity Plan, specifically designed for new hires as per Nasdaq Listing Rule 5635(c)(4).