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Scholar Rock Holding Corporation develops biologic therapies for spinal muscular atrophy and other rare, severe, and debilitating neuromuscular diseases through its myostatin biology platform. Its principal program, apitegromab, is an anti-myostatin therapy being developed for children and adults with SMA, and its pipeline also includes subcutaneous apitegromab and SRK-439.
Recurring company updates include FDA regulatory activity for apitegromab, manufacturing and fill-finish matters tied to the program, quarterly financial results, cash and financing activity such as debt and at-the-market equity programs, and Nasdaq inducement equity grants for new employees. Scholar Rock also reports investor-conference participation and pipeline commentary related to anti-myostatin biology.
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.
Scholar Rock (NASDAQ: SRRK), a late-stage biopharmaceutical company developing apitegromab for spinal muscular atrophy (SMA), has granted inducement equity awards to 9 new employees. The awards include 69,029 stock options with an exercise price of $31.58 and 51,771 restricted stock units.
The awards are governed by the Company's 2022 Inducement Equity Plan and comply with Nasdaq Listing Rule 5635(c)(4). 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 developing apitegromab for spinal muscular atrophy (SMA), has granted inducement equity awards to 64 new employees. The awards include 243,577 stock options with an exercise price of $31.46 and 182,673 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) announced the publication of pivotal Phase 3 SAPPHIRE trial results for apitegromab in The Lancet Neurology. The trial demonstrated statistically significant motor function improvements in SMA patients receiving SMN-targeted treatment. Key findings include a 1.8-point mean improvement in HFMSE scores (p=0.019) versus placebo, with 30.4% of patients showing ≥3-point improvement compared to 12.5% on placebo.
The FDA has accepted apitegromab's BLA under priority review with a PDUFA date of September 22, 2025. Scholar Rock plans to launch commercially in the U.S. in 2025 and Europe in 2026, pending regulatory approvals. The treatment demonstrated consistent benefits across age groups and was well-tolerated, maintaining its established safety profile.
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.