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) resubmitted the apitegromab BLA to the FDA on March 31, 2026, including Catalent Indiana and a second U.S. fill-finish facility. The company expects FDA acceptance within 30 days and a PDUFA action date in late September 2026.
Updates were limited in scope, mainly a standard safety update; EMA MAA review is proceeding with a decision anticipated mid-2026. Apitegromab retains Fast Track, Priority Review, Orphan Drug, Rare Pediatric Disease, and EMA PRIME designations.
Scholar Rock (NASDAQ: SRRK) granted inducement equity awards covering 60,655 shares to five newly hired employees on March 13, 2026. Awards include inducement stock options for 24,506 shares at an exercise price of $44.23 and inducement restricted stock units for 36,149 shares.
Options vest 25% after one year then quarterly over three years; RSUs vest in four equal annual installments. Awards are governed by the company’s 2022 Inducement Equity Plan under Nasdaq Rule 5635(c)(4).
Scholar Rock (NASDAQ:SRRK) reported Q4 2025 net loss of $91.0M and FY 2025 net loss of $377.9M, with no revenue. The company had $367.6M in cash and marketable securities as of December 31, 2025, and secured a debt facility of up to $550M to support apitegromab commercialization.
Apitegromab BLA resubmission is planned after a successful FDA reinspection; FDA and EMA milestones and commercial launch activities are expected through 2026.
Summary not available.
Scholar Rock (NASDAQ: SRRK) will present at three investor conferences in March 2026 via fireside chats and webcasts. Management will speak at TD Cowen on March 4, 2026 (1:50 p.m. ET, Boston), Leerink on March 10, 2026 (2:30 p.m. ET, Miami) and Barclays on March 12, 2026 (8:30 a.m. ET, Miami).
A live webcast will be available on the company Investors > Events and Presentations page, and replays will remain accessible for approximately 90 days.
Scholar Rock (NASDAQ: SRRK) granted inducement equity awards covering 114,668 shares to seven new hires: 64,226 inducement options and 50,442 inducement restricted stock units. The options carry an exercise price of $47.85, equal to the closing price on February 9, 2026.
Vesting: options vest 25% after one year then quarterly over three years; RSUs vest in four equal annual installments. Awards are issued under the company’s 2022 Inducement Equity Plan pursuant to Nasdaq Listing Rule 5635(c)(4) and are subject to standard service-based vesting conditions.
Scholar Rock (NASDAQ: SRRK) will report fourth quarter and full year 2025 financial results on Tuesday, March 3, 2026, before markets open. Management will host a conference call and live webcast at 8:00 a.m. ET.
Access the live audio webcast via the Investors "Events and Presentations" page on the Scholar Rock website. Telephone participants must register in advance and will receive a confirmation email with dial‑in instructions. An archived replay will be available on the company website for approximately 90 days.
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
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.