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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), 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).
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).