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), a late-stage biopharmaceutical company specializing in treatments for neuromuscular diseases, cardiometabolic disorders, and other serious diseases, has scheduled a conference call for May 14, 2025, at 8:15am ET. The call will cover the company's first quarter 2025 financial results and provide a business update.
Participants can join via telephone by pre-registering through the provided link, after which they will receive dial-in details. The call will also be available as a live audio webcast in the Investor Relations section of Scholar Rock's website. A replay will remain accessible on the company website for approximately 90 days.
Scholar Rock (NASDAQ: SRRK) announced significant leadership changes, with David Hallal, who has served as Chairman since 2017, appointed as Chief Executive Officer. The transition comes as the company prepares for the global launch of apitegromab for Spinal Muscular Atrophy (SMA), which is currently under priority review.
Three key executives have joined the leadership team: Akshay Vaishnaw, M.D., Ph.D. as President of R&D (former President of Alnylam), R. Keith Woods as Chief Operating Officer (former COO of argenx), and Vikas Sinha as Chief Financial Officer (former CFO of Alexion and ElevateBio).
Current CEO Jay Backstrom, M.D., will transition to a strategic advisor role, continuing to work with the executive team and Board of Directors. Under his three-year leadership, the company successfully completed apitegromab's global Phase 3 program and initiated US and European regulatory processes for marketing authorization.
Scholar Rock (NASDAQ: SRRK) has announced the granting of inducement equity awards to 19 newly hired employees. The awards consist of inducement stock options to purchase 89,515 shares of common stock and inducement restricted stock units covering 67,135 shares.
The awards are governed by the Company's 2022 Inducement Equity Plan and related agreements. The stock options have an exercise price of $28.93, matching the closing price on April 14, 2025. The vesting schedule includes 25% of shares vesting on the first employment anniversary, with the remaining 75% vesting in 12 quarterly installments. The restricted stock units will vest in four equal annual installments, contingent on continued employment.
Scholar Rock (NASDAQ: SRRK) has received FDA Priority Review for its Biologics License Application (BLA) for apitegromab, a first-in-class muscle-targeted treatment for Spinal Muscular Atrophy (SMA). The FDA has set a PDUFA date of September 22, 2025.
Additionally, the European Medicines Agency (EMA) has validated the Marketing Authorisation Application (MAA) for apitegromab. The submissions are supported by positive data from the Phase 3 SAPPHIRE trial, which demonstrated statistically significant and clinically meaningful motor function improvements in SMA patients receiving apitegromab alongside SMN-targeted treatments.
The company is preparing for commercial launch in the U.S. in 2025, followed by European launch in 2026. The FDA's priority review designation indicates potential significant improvement in treatment effectiveness for SMA patients.
Scholar Rock (NASDAQ: SRRK) announced new Phase 3 SAPPHIRE trial data for apitegromab, their investigational muscle-targeted therapy for Spinal Muscular Atrophy (SMA). The trial met its primary endpoint with statistically significant improvement in motor function, showing a mean difference of 1.8 points (p=0.0192) in Hammersmith Functional Motor Scale Expanded (HFMSE) versus placebo.
Key secondary endpoints revealed that 30.4% of patients receiving apitegromab achieved ≥3-point HFMSE improvement compared to 12.5% on placebo (p=0.0156). The treatment demonstrated consistent benefits across all subgroups and showed improvements in Revised Upper Limb Module (RULM) and WHO motor development milestones.
The drug was well-tolerated with no serious adverse events related to apitegromab, positioning it as a potential complementary therapy to existing SMN-targeted treatments.
Scholar Rock (NASDAQ: SRRK), a late-stage biopharmaceutical company, has announced new employee inducement grants under its 2022 Inducement Equity Plan. The company has awarded equity grants to seven new employees, including:
- 65,027 shares as inducement stock options with an exercise price of $35.15
- 48,773 shares as inducement 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 grants, totaling 113,800 shares, are designed to attract new talent and comply with Nasdaq Listing Rule 5635(c)(4).
Scholar Rock (NASDAQ: SRRK) reported its full year 2024 financial results, highlighting significant progress in its drug development pipeline. The company submitted a BLA for apitegromab in SMA patients and plans to submit an EU marketing application in Q1 2025, with US launch anticipated in Q4 2025.
Key financial metrics include a net loss of $246.3 million ($2.47 per share) for 2024, compared to $165.8 million in 2023. R&D expenses increased to $184.6 million, while G&A expenses rose to $67.5 million. The company ended 2024 with $437.3 million in cash and equivalents, expected to fund operations into Q4 2026.
Notable upcoming milestones include topline data from the Phase 2 EMBRAZE obesity trial in Q2 2025 and an IND application for SRK-439 in Q3 2025. The company also completed a $345 million public offering in October 2024 to support commercial launch preparations.
Scholar Rock (NASDAQ: SRRK), a late-stage biopharmaceutical company specializing in treatments for spinal muscular atrophy (SMA), cardiometabolic disorders, and diseases involving protein growth factors, has announced its participation in four major investor conferences in March:
- TD Cowen 45th Annual Health Care Conference - March 4 in Boston (fireside chat at 2:30 p.m. ET)
- Wedbush Cardiometabolic Conference - March 10 in Miami (panel presentation at 10:05 a.m. ET)
- Jefferies Biotech on the Bay Summit - March 11 in Miami (1x1 meetings)
- BMO Obesity Summit - March 25 in New York City (panel presentation at 1:15 p.m. ET)
A live webcast of the Cowen presentation will be available on the company's investor website, with replay access for approximately 90 days.