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.
Scholar Rock Holding Corporation (SRRK) is a clinical-stage biopharmaceutical company pioneering targeted therapies that modulate growth factor activation in serious diseases. This page serves as the definitive source for official updates, including clinical trial progress, regulatory milestones, and strategic partnerships.
Investors and researchers will find curated news spanning SRRK's neuromuscular, oncology, and metabolic disorder pipelines. Content includes earnings reports, scientific presentations, and manufacturing updates—all essential for tracking the company's novel niche modulator platform.
Key focus areas include apitegromab in spinal muscular atrophy, obesity therapeutics, and fibrosis interventions. Updates are organized chronologically with clear sourcing to maintain transparency. Bookmark this page for streamlined access to SRRK's advancements in precision biologics.
Scholar Rock (SRRK) has submitted a Biologics License Application (BLA) to the FDA for apitegromab, a muscle-targeted therapy for Spinal Muscular Atrophy (SMA) patients. The submission is based on the successful Phase 3 SAPPHIRE trial, which demonstrated a statistically significant 1.8-point improvement in motor function compared to placebo at week 52, measured by the Hammersmith Functional Motor Scale-Expanded.
The company has received Fast Track, Orphan Drug, and Rare Pediatric Disease Designations from the FDA, and plans to submit a Marketing Authorisation Application to the European Medicines Agency in Q1 2025. Scholar Rock has requested Priority Review, which could reduce FDA review time to six months. Additionally, the company plans to initiate the Phase 2 OPAL trial in mid-2025 to study apitegromab in SMA patients under two years of age.
Scholar Rock (NASDAQ: SRRK) has appointed Lisa Wyman as Chief Technical and Quality Officer (CTQO) to support the company's transformation into a fully integrated biopharma company ahead of its first expected drug approval and commercial launch in 2025. Wyman brings over 20 years of leadership experience in technical and quality operations from her roles at Generate:Biomedicines and Acceleron Pharma.
As part of organizational restructuring, the Chief Operating Officer role is being eliminated. Ted Myles, current COO & CFO, will remain with the company through mid-March and serve as a Senior Advisor for six months during the transition. The company has initiated a search for a new CFO.
At her previous position as Chief Technical Operations Officer at Generate:Biomedicines, Wyman led global technical operations and CMC development. At Acceleron, she played a key role in transforming the company from an R&D-focused entity to an integrated biotech, contributing to its $11 billion acquisition by Merck & Co. in 2021.
Scholar Rock (NASDAQ: SRRK) has granted inducement equity awards to three new employees, comprising stock options for 27,429 shares and restricted stock units for 20,571 shares, totaling 48,000 shares of common stock. The awards are part of the company's 2022 Inducement Equity Plan, specifically designed for new hires.
The inducement stock options were priced at $42.60, matching the closing price on January 13, 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 (SRRK) outlined its 2025 strategic priorities, focusing on three key areas: commercializing apitegromab in SMA, expanding its benefits, and advancing their anti-myostatin program in cardiometabolic disorders. The company plans to submit BLA and MAA applications for apitegromab in Q1 2025, with U.S. launch expected in Q4 2025.
Key upcoming milestones include initiating the Phase 2 OPAL trial in SMA patients under two years old in mid-2025, expecting data from Phase 2 EMBRAZE obesity trial in Q2 2025, and filing an IND application for SRK-439 in Q3 2025. The company reported positive topline data from the SAPPHIRE trial in October 2024, showing significant improvement in motor function for SMA patients.
Scholar Rock's financial position remains strong, with funding expected to last into Q4 2026, supported by a successful $345 million public offering completed in October.
Scholar Rock (NASDAQ: SRRK), a late-stage biopharmaceutical company specializing in treatments for spinal muscular atrophy (SMA), cardiometabolic disorders, and diseases involving protein growth factors, has announced its upcoming presentation at the 43rd Annual J.P. Morgan Healthcare Conference.
The presentation is scheduled for Tuesday, January 14, 2025, at 9:45 a.m. PT (12:45 p.m. ET). Interested parties can access a live webcast through the Investors & Media section of Scholar Rock's website. The presentation recording will remain available on the company's website for approximately 90 days following the event.
Scholar Rock (NASDAQ: SRRK) has granted inducement equity awards to twelve new employees, totaling 208,800 shares of common stock. The awards consist of 119,312 shares as stock options with an exercise price of $45.48 and 89,488 shares as restricted stock units. The stock options will vest 25% after one year, with the remaining 75% vesting in 12 quarterly installments. The restricted stock units will vest in four equal annual installments. These grants were made 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) has granted inducement equity awards to four new employees, including stock options for 57,429 shares and restricted stock units for 43,071 shares. The stock options, priced at $28.15 per share, will vest 25% after one year and the remaining 75% in quarterly installments. The restricted stock units will vest in four equal annual installments. These grants, made under the company's 2022 Inducement Equity Plan, are designed to attract new talent to the late-stage biopharmaceutical company, which focuses on treatments for spinal muscular atrophy and cardiometabolic disorders.
Scholar Rock (SRRK) reported positive Phase 3 SAPPHIRE trial results for apitegromab in Spinal Muscular Atrophy (SMA), achieving its primary endpoint with statistically significant motor function improvement. The company plans to submit BLA and MAA applications in Q1 2025. The Phase 2 EMBRAZE obesity trial enrollment is complete with data expected in Q2 2025. Financial highlights include completion of a $345M public offering and Q3 2024 net loss of $64.5M ($0.66/share). Cash position stands at $139.1M, with pro forma balance of $463.5M including October offering, extending runway into Q4 2026.
Scholar Rock (NASDAQ: SRRK) announced new preclinical data for SRK-439, showing significant lean mass increase and enhanced fat mass loss when combined with metformin. In young mice, the combination treatment demonstrated a 31.6% increase in lean mass compared to 15.1% in controls, while older mice showed a 10.2% increase versus 0.2% in controls. The study also revealed lower fat mass gain in young mice receiving the combination treatment (68.2% increase) compared to metformin alone (114% increase). These results support the potential of selective myostatin inhibition in improving body composition for obesity treatment. The company's Phase 2 EMBRAZE trial is on track for readout in Q2 2025.
Scholar Rock (NASDAQ: SRRK) announced it will host a conference call to discuss third quarter 2024 financial results and provide a business update on Tuesday, November 12, 2024, at 8:15am ET. The company, which focuses on developing treatments for spinal muscular atrophy, cardiometabolic disorders, and other diseases involving protein growth factors, will make the audio webcast available on their investor relations website. Participants can register online to join via telephone or web.
FAQ
What is the current stock price of Scholar Rock Holding (SRRK)?
What is the market cap of Scholar Rock Holding (SRRK)?
