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Scholar Rock Holding Corporation (SRRK) is a biotechnology company dedicated to pioneering a novel class of biologic therapies known as 'niche modulators'. These therapies selectively target the activation of growth factors within the disease microenvironment, offering a groundbreaking approach to treating serious medical conditions. Scholar Rock's initial proprietary and partnered drug discovery programs focus on specific growth factors, particularly members of the TGF-beta superfamily, which are critical in regulating cell growth and differentiation. These growth factors are notably present in the microenvironments of significant diseases like fibrosis, musculoskeletal disorders, and autoimmune diseases.
The company’s innovative therapeutic strategy stems from the foundational scientific discoveries of its founders, Professors Timothy Springer, PhD, and Leonard Zon, MD, from Children's Hospital Boston and Harvard Medical School. These discoveries illuminate the molecular mechanisms of growth factor activation, empowering Scholar Rock to advance its ground-breaking treatments.
Scholar Rock is backed by a consortium of top-tier life sciences investors, including Polaris Partners and Arch Venture Partners. Its flagship product candidate, Apitegroma, is a selective, fully human, monoclonal antibody that inhibits the activation of the growth factor myostatin in skeletal muscle. This innovative mechanism holds promise for treating neuromuscular disorders. Another key product in the company's pipeline is SRK-181, which targets the activation of latent transforming growth factor beta-1 (TGFβ1) and is being developed to treat cancers that are resistant to existing anti-PD-(L)1 antibody therapies.
With its operations based in the United States, Scholar Rock continues to make significant strides in the biopharmaceutical industry, pushing the envelope of medical science and offering hope for effective treatments against some of the most challenging diseases.
Scholar Rock (NASDAQ: SRRK) announced it will present additional data from its Phase 3 SAPPHIRE clinical trial at the 2025 MDA Clinical & Scientific Conference in Dallas. The trial evaluated apitegromab, a muscle-targeted therapy for spinal muscular atrophy (SMA) patients receiving SMN-targeted treatments.
Following positive topline data in October 2024 and BLA submission to FDA in January 2025, Dr. Thomas O. Crawford from Johns Hopkins University will present detailed trial analysis through an oral presentation and poster on March 19th. Additionally, the company will present preclinical data combining apitegromab with a dystrophin corrector for Duchenne muscular dystrophy (DMD).
Scholar Rock (NASDAQ: SRRK) has granted inducement equity awards to eleven new employees, totaling 371,500 shares of common stock. The awards consist of inducement stock options for 212,284 shares and restricted stock units for 159,216 shares. The stock options have an exercise price of $38.14, matching the closing price on February 10, 2025.
These awards are part of the Company's 2022 Inducement Equity Plan, exclusively used for granting equity to new hires. 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. All vesting is contingent on continued employment with Scholar Rock.
Scholar Rock (NASDAQ: SRRK), a late-stage biopharmaceutical company focused on treatments for spinal muscular atrophy (SMA), cardiometabolic disorders, and other diseases involving protein growth factors, has scheduled a conference call for February 27, 2025, at 8:15am ET. The call will cover fourth quarter and full-year 2024 financial results along with a business update.
The company will provide multiple ways to access the call, including a live audio webcast available through the Investor Relations section of Scholar Rock's website. An archived replay will remain accessible on the website for approximately 90 days after the event.
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.
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