Scholar Rock, a late-stage biopharmaceutical company, has made significant changes to its leadership team to prepare for the global launch of Apitegromab, a potential treatment for spinal muscular atrophy (SMA). David L. Hallal has been appointed as the new Chief Executive Officer, succeeding Jay Backstrom, M.D., who will serve as a strategic advisor. The company has also added three key leaders to its team.
Akshay Vaishnaw, M.D., Ph.D., has been named President of R&D, R. Keith Woods has been appointed Chief Operating Officer, and Vikas Sinha is joining as Chief Financial Officer. These appointments bring extensive experience in building and leading global organizations focused on developing and commercializing life-changing therapies.
Under the leadership of Jay Backstrom, Scholar Rock successfully advanced Apitegromab through a pivotal phase 3 study and is now on the path to becoming a commercial company. The Biologics License Application (BLA) for Apitegromab has been accepted under priority review, and the company anticipates a launch later this year.
Apitegromab is an investigational fully human monoclonal antibody targeting myostatin activation in the skeletal muscle. It is the first muscle-targeted treatment candidate in SMA to demonstrate clinical success in a pivotal phase 3 trial. The U.S. Food and Drug Administration (FDA) has granted fast track, orphan drug, and rare pediatric disease designations to Apitegromab for the treatment of SMA.
Spinal Muscular Atrophy (SMA) is a rare, genetic neuromuscular disease characterized by the loss of motor neurons, muscle atrophy, and progressive weakness. There is a high unmet need for therapies that directly address the progressive muscle weakness in SMA.
Scholar Rock's commitment to developing life-changing therapies is powered by its proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. The company aims to advance the standard of care for neuromuscular disease, cardiometabolic disorders, cancer, and other conditions.
The company will host a conference call to discuss the new leadership appointments on April 28, 2025, at 8:30 am ET. The live audio webcast of the call will be available on the company's website.
These leadership changes and the progress with Apitegromab demonstrate Scholar Rock's commitment to advancing innovative treatments for serious diseases and its efforts to become a global biotech leader. As a result of these announcements, the company's shares have moved -3.3% on the market, and are now trading at a price of $31.74. For more information, read the company's full 8-K submission here.
