Scholar Rock Holding Stock Price, News & Analysis

Scholar Rock (SRRK) has appointed Rebecca McLeod as Chief Brand Officer and U.S. General Manager to lead the anticipated U.S. commercial launch of apitegromab for spinal muscular atrophy (SMA) patients. McLeod, a 25-year industry veteran, previously served as argenx U.S. General Manager where she successfully led the launch of VYVGART for gMG and CIDP. In her new role, she will be responsible for establishing global brand strategy and market positioning for apitegromab across Europe, Asia-Pacific, and Latin America. McLeod's extensive experience includes leadership positions at Alexion Pharmaceuticals and Takeda Pharmaceuticals, with her most recent achievement being one of the most successful biopharmaceutical franchise launches with VYVGART at argenx.

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 (SRRK) reported Q1 2025 financial results and significant progress in its drug development programs. The FDA has accepted their BLA for apitegromab with priority review for Spinal Muscular Atrophy (SMA), setting a PDUFA date of September 22, 2025. The European Medicines Agency also validated their Marketing Authorization Application. The company reported a net loss of $74.7 million ($0.67 per share) and holds $364.4 million in cash and equivalents, expected to fund operations into 2027. Key upcoming milestones include topline results from the Phase 2 EMBRAZE obesity trial in June 2025, initiation of the Phase 2 OPAL trial in SMA in Q3 2025, and an IND application for SRK-439 in Q3 2025. The company has strengthened its leadership team with strategic appointments in preparation for commercial launch.

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 (SRRK) announced equity inducement grants to two new executive hires. R. Keith Woods (Chief Operating Officer) and Vikas Sinha (Chief Financial Officer) received awards covering up to 1,420,134 total shares, including: - 110,067 stock options each (exercise price: $32.91) - 100,000 restricted stock units (RSUs) each - Up to 500,000 performance-based RSUs (PSUs) each The stock options will vest 25% after one year, with remaining 75% vesting quarterly over 3 years. RSUs will vest in 4 equal annual installments. PSUs are subject to performance and time-based conditions. All awards were granted under the company's 2022 Inducement Equity Plan for new employees.

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.