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) granted inducement equity awards to two newly hired employees covering an aggregate of 35,200 shares of common stock: inducement stock options for 20,400 shares and inducement restricted stock units for 14,800 shares.
The options have an exercise price of $43.56, equal to the closing price on January 12, 2026. Options vest 25% on the first anniversary of each employee’s start date, with the remaining 75% vesting in 12 equal quarterly installments. RSUs vest in four equal annual installments. All vesting is conditioned on continued service and the awards are issued under the Company’s 2022 Inducement Equity Plan pursuant to Nasdaq Listing Rule 5635(c)(4).
Scholar Rock (NASDAQ: SRRK) outlined 2026 priorities focused on regulatory approvals and commercialization of apitegromab for children and adults with spinal muscular atrophy (SMA). The company expects a BLA resubmission and U.S. launch in 2026 following FDA interactions and remediation work at a Catalent fill-finish site, and an EMA decision expected mid-2026. Apitegromab development includes a Phase 2 OPAL trial in <2-year-old patients and a planned Phase 2 FORGE trial in FSHD (IND cleared) starting mid-2026. SRK-439 and subcutaneous apitegromab programs are advancing; SRK-439 topline data expected H2 2026. Cash of approximately $365M as of Dec 31, 2025, expected to fund operations into 2027.
Scholar Rock (NASDAQ: SRRK) said management will present at the 44th Annual J.P. Morgan Healthcare Conference on Monday, January 12, 2026 at 7:30 a.m. PST (10:30 a.m. EST).
A live webcast will be available on the company’s Investors > Events and Presentations page at http://investors.scholarrock.com, and a replay will be accessible for approximately 90 days.
Scholar Rock (NASDAQ: SRRK) granted inducement equity awards totaling 7,800 shares to two newly hired employees on December 13, 2025. The package comprises inducement stock options for 4,457 shares and inducement restricted stock units for 3,343 shares, issued under the Company’s 2022 Inducement Equity Plan pursuant to Nasdaq Listing Rule 5635(c)(4).
The inducement options have an exercise price of $45.25 (equal to the closing price on December 8, 2025). Option vesting: 25% on first anniversary of each start date, then the remaining 75% in 12 equal quarterly installments. RSU vesting: four equal annual installments. All vesting is subject to continued employment.
Scholar Rock (NASDAQ: SRRK) reported third quarter 2025 results and program updates on November 14, 2025. The company completed an in-person Type A meeting with the FDA on November 12 regarding the apitegromab BLA and expects to resubmit and aim for a U.S. launch following approval in 2026. Catalent (Novo Nordisk) reported remediation progress and expects reinspection readiness by year-end 2025. Scholar Rock accelerated U.S. fill-finish capacity with tech transfer and commercial capacity reserved beginning Q1 2026. Dosing began in the Phase 2 OPAL study in infants/toddlers; EMA review expected by mid-2026. SRK-439 IND cleared and dosing in healthy volunteers expected in Q4 2025. Cash and marketable securities totaled $369.6M at September 30, 2025, expected to fund operations into 2027.
Scholar Rock (NASDAQ: SRRK) announced inducement equity awards granted to one newly hired employee on November 12, 2025. The awards total 30,000 shares comprised of 17,143 stock options and 12,857 restricted stock units under the company’s 2022 Inducement Equity Plan pursuant to Nasdaq Listing Rule 5635(c)(4).
The options carry an exercise price of $29.37 (equal to the Nov 10, 2025 closing price). Option vesting: 25% after one year then quarterly over three years; RSU vesting: four equal annual installments. Vesting is conditioned on continuing service.
Scholar Rock (NASDAQ: SRRK) said management will participate in a fireside chat at the 2025 Jefferies Global Healthcare Conference on Tuesday, November 18, 2025 at 3:30 p.m. GMT in London, UK.
A live webcast will be available on the company’s Investors "Events and Presentations" page at http://investors.scholarrock.com, and a replay will be accessible for approximately 90 days.
Scholar Rock (NASDAQ: SRRK) will report third quarter 2025 financial results on Friday, November 14, 2025, before the financial markets open.
Management will host a live audio webcast at 8:00 a.m. ET following the release. Investors can access the live audio webcast via the company’s Investors > Events and Presentations page and may participate by telephone after registering in advance. Telephone registrants will receive a confirmation email with call-in details. An archived replay of the webcast will be available on the company website for approximately 90 days.
Scholar Rock (NASDAQ: SRRK) granted inducement equity awards covering an aggregate of 114,500 shares of common stock to six newly hired employees on October 17, 2025.
The awards consist of inducement stock options for 65,429 shares and inducement restricted stock units for 49,071 shares, issued under the Company’s 2022 Inducement Equity Plan pursuant to Nasdaq Listing Rule 5635(c)(4).
The inducement options have an exercise price of $34.275 (equal to the closing price on October 13, 2025). Option vesting: 25% at first anniversary of each employee’s start date, then the remaining 75% in 12 equal quarterly installments. RSU vesting: four equal annual installments. All vesting is conditioned on continued service.
Scholar Rock (NASDAQ: SRRK) received a Complete Response Letter (CRL) from the FDA regarding its Biologics License Application (BLA) for apitegromab, a treatment for Spinal Muscular Atrophy (SMA). The CRL is solely related to observations at Catalent Indiana LLC, a third-party fill-finish facility, and not specific to apitegromab.
The FDA cited no other approvability concerns regarding apitegromab's efficacy, safety data, or drug substance manufacturing. Catalent Indiana submitted a comprehensive response in August 2025 and continues remediation efforts. Scholar Rock plans to resubmit the BLA once manufacturing issues are resolved.
Apitegromab holds multiple FDA designations including Orphan Drug, Rare Pediatric Disease, Priority Review, and Fast Track. In Europe, the marketing authorization application is under review with a decision expected by mid-2026.
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