Scholar Rock Holding Corporation - Common Stock (SRRK)

Scholar Rock (NASDAQ: SRRK), a late-stage biopharmaceutical company focused on developing and commercializing apitegromab for patients with spinal muscular atrophy (SMA) and other severe and debilitating neuromuscular diseases, announced today that it will present data from its Phase 3 SAPPHIRE clinical trial (NCT05156320) in an oral presentation at Cure SMA’s Annual SMA Research & Clinical Care Meeting being held June 25-27, 2025, in Anaheim, California.

Apitegromab therapy with Tirzepatide preserved an additional 4.2 pounds of lean mass compared to Tirzepatide alone in the study, the company said.

Scholar Rock's apitegromab helped preserve muscle mass during tirzepatide-induced weight loss, improving overall body composition in Phase 2 trial.

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Scholar Rock (NASDAQ: SRRK), a late-stage biopharmaceutical company focused on developing and commercializing apitegromab for patients with spinal muscular atrophy (SMA) and additional severe and debilitating neuromuscular diseases, today announced positive results from the Phase 2 EMBRAZE proof-of-concept trial assessing apitegromab in combination with tirzepatide to preserve lean mass during tirzepatide-induced weight loss. The trial demonstrated that 30% of total weight loss with tirzepatide alone was due to lean mass loss. Apitegromab therapy (10 mg/kg) with tirzepatide preserved an additional 4.2 pounds (1.9 kilograms) or 54.9% (p=0.001) of lean mass compared to tirzepatide alone, leading to higher quality weight loss. Apitegromab with tirzepatide was generally well tolerated by participants.

Scholar Rock (NASDAQ: SRRK; the “Company”), a late-stage biopharmaceutical company focused on developing and commercializing apitegromab for patients with spinal muscular atrophy (SMA) and other severe and debilitating neuromuscular diseases, today announced that the company granted inducement equity awards covering an aggregate of 309,700 shares of its common stock to 11 newly hired employees, consisting of inducement stock options to purchase an aggregate of 176,963 shares of common stock and inducement restricted stock units, covering an aggregate of 132,737 shares of its common stock.

Jefferies thinks big pharma companies are "still on the hunt" for deals.

Scholar Rock (NASDAQ: SRRK), a late-stage biopharmaceutical company focused on developing and commercializing apitegromab for patients with spinal muscular atrophy (SMA) and other severe and debilitating neuromuscular diseases, today announced that David L. Hallal, Chief Executive Officer, and members of management will participate in a fireside chat at the 46th Annual Goldman Sachs Global Healthcare Conference on Wednesday, June 11 at 9:20 a.m. ET in Miami, Florida.

Scholar Rock (NASDAQ: SRRK), a late-stage biopharmaceutical company focused on developing and commercializing apitegromab for patients with spinal muscular atrophy (SMA) and other severe and debilitating neuromuscular diseases, today announced that Rebecca McLeod has been appointed to the newly created role of Chief Brand Officer and U.S. General Manager. In this role, she will be responsible for leading the anticipated U.S. commercial launch of apitegromab for patients with SMA – along with establishing the global apitegromab brand strategy and market positioning for Europe, Asia-Pacific and Latin America.

Scholar Rock (NASDAQ: SRRK), a late-stage biopharmaceutical company focused on developing and commercializing apitegromab for patients with spinal muscular atrophy (SMA) and other severe and debilitating neuromuscular diseases, today announced that David L. Hallal, Chief Executive Officer, and members of the management team will participate in a fireside chat at the Jefferies Global Healthcare Conference on Wednesday, June 4 at 3:45 p.m. ET in New York City.

Scholar Rock (NASDAQ: SRRK; the “Company”), a late-stage biopharmaceutical company focused on developing and commercializing apitegromab for patients with spinal muscular atrophy (SMA) and other severe and debilitating neuromuscular diseases, today announced that the company granted inducement equity awards covering an aggregate of 105,700 shares of its common stock to 14 newly hired employees, consisting of inducement stock options to purchase an aggregate of 60,400 shares of common stock and inducement restricted stock units, covering an aggregate of 45,300 shares of its common stock.

Scholar Rock (NASDAQ: SRRK), a late-stage biopharmaceutical company focused on developing and commercializing apitegromab for patients with spinal muscular atrophy (SMA) and other severe and debilitating neuromuscular diseases, today reported financial results and updates for the first quarter ended March 31, 2025.

Scholar Rock (NASDAQ: SRRK), a late-stage biopharmaceutical company focused on advancing innovative treatments for neuromuscular diseases, cardiometabolic disorders, and other serious diseases, today announced that management will host a conference call to discuss its first quarter 2025 financial results and provide a business update on Wednesday, May 14, 2025, at 8:15am ET.

Scholar Rock (NASDAQ: SRRK; the “Company”), a late-stage biopharmaceutical company focused on advancing innovative treatments for neuromuscular diseases, cardiometabolic disorders, and other serious diseases, today announced that the company granted inducement equity awards to R. Keith Woods, its newly named Chief Operating Officer and Vikas Sinha, its newly named Chief Financial Officer, covering an aggregate of up to 1,420,134 shares of its common stock, consisting of 110,067 stock options to purchase shares of common stock, 100,000 restricted stock units (“RSUs”), and up to 500,000 performance based restricted stock units (“PSUs”) to each executive.

Scholar Rock (NASDAQ: SRRK), a late-stage biopharmaceutical company focused on advancing innovative treatments for neuromuscular diseases, cardiometabolic disorders, and other serious diseases, announced today that David Hallal has been appointed Chief Executive Officer succeeding Jay Backstrom, M.D. David Hallal has served as Chairman of the Board at Scholar Rock since 2017 and just prior to that spent more than a decade as CEO, COO, and CCO of Alexion building and leading the company’s 50-country operating platform. As part of this planned transition, Dr. Backstrom will serve as a strategic advisor, working closely with the company’s executive team and Board of Directors.

Scholar Rock (NASDAQ: SRRK; the “Company”), a late-stage biopharmaceutical company focused on advancing innovative treatments for neuromuscular diseases, cardiometabolic disorders, and other serious diseases, today announced that the company granted inducement equity awards covering an aggregate of 156,650 shares of its common stock to 19 newly hired employees, consisting of inducement stock options to purchase an aggregate of 89,515 shares of common stock and inducement restricted stock units, covering an aggregate of 67,135 shares of its common stock.

Scholar Rock (NASDAQ: SRRK), a late-stage biopharmaceutical company focused on advancing innovative treatments for neuromuscular diseases, cardiometabolic disorders, and other serious diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for apitegromab, an investigational muscle-targeted treatment that is being developed to provide clinically meaningful improvement in motor function for people living with spinal muscular atrophy (SMA) who are receiving an SMN-targeted treatment. The FDA will review the application under priority review and has assigned a Prescription Drug User Fee Act (PDUFA) target action date of September 22, 2025. The FDA priority review designation conveys that the FDA has determined that if apitegromab is approved, it could offer significant improvement in the safety or effectiveness of treatment of the serious condition of SMA.

Scholar Rock will present new Phase 3 SAPPHIRE trial data on apitegromab at the 2025 MDA conference, highlighting efficacy and safety in SMA treatment.