NASDAQ:SRRK

Scholar Rock files prospectus supplement for up to 200 million dollars ATM offering

Scholar Rock Holding Corporation filed a prospectus supplement with the SEC on November 14, 2025, activating a new phase of its at-the-market offering program with Jefferies LLC. Under the updated filing, the company may sell up to 200 million dollars in additional shares of common stock at its discretion through Jefferies as sales agent.

The shares are registered under Scholar Rock’s automatic shelf registration statement filed in October 2024. Goodwin Procter LLP issued the related legal opinion, included as an exhibit. The company emphasized that the Form 8-K does not itself constitute an offer to sell the securities, and any sales will only be made under the prospectus supplement in compliance with applicable securities laws.
Scholar Rock files prospectus supplement for 200 million dollar at-the-market offering

Scholar Rock Holding Corporation filed a new prospectus supplement with the SEC to expand its at-the-market equity offering program, allowing the company to sell up to 200 million dollars in additional common stock through Jefferies as sales agent.

The shares will be issued under the company’s existing shelf registration, originally filed in October 2024.
Scholar Rock Notes FDA Action on Novo Nordisk’s Catalent Facility

Scholar Rock Holding Corp. (NASDAQ: SRRK) announced that Novo Nordisk notified the company the U.S. FDA has classified its Catalent Indiana facility inspection as “Official Action Indicated” (OAI) following a Form 483 issued in July 2025, signaling potential regulatory follow-up or enforcement actions at the site.
Scholar Rock announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for its Biologics License Application for apitegromab, a potential treatment for spinal muscular atrophy (SMA). The CRL was issued solely due to manufacturing observations at Catalent Indiana LLC, a third-party fill-finish facility, and did not raise concerns about apitegromab’s safety or efficacy data. Scholar Rock plans to resubmit the application once Catalent’s remediation efforts are completed. Apitegromab, which has received multiple FDA designations including Orphan Drug and Fast Track, is the first muscle-targeted therapy candidate to show clinical success in SMA and remains under review by the European Medicines Agency, with a decision expected in mid-2026.
Scholar Rock Announces Auditor Transition Following Ernst & Young LLP’s Decision Not to Seek Reappointment

Scholar Rock Holding Corporation has disclosed that Ernst & Young LLP will not stand for re-election as the company’s independent registered public accounting firm for the fiscal year ending December 31, 2025. The firm will conclude its services following the submission of the company's quarterly report for the period ending March 31, 2025.

The audit reports provided by EY for the fiscal years 2023 and 2024 did not include any adverse opinions, disclaimers, or modifications related to uncertainty, scope, or accounting principles. Additionally, the company confirmed that there were no disagreements or reportable events with EY on matters concerning accounting or auditing standards during the audit periods in question.

Scholar Rock has begun the process of engaging a new independent auditor and will announce the new appointment in accordance with SEC regulations. EY has submitted a letter to the SEC agreeing with the company's disclosures regarding the transition.
Scholar Rock Holding Corporation (Nasdaq: SRRK) announced key leadership changes. Lisa Wyman has been appointed as Chief Technical and Quality Officer, effective January 27, 2025. The company also disclosed a planned leadership transition, including the departure of Edward H. Myles, its Chief Operating Officer and Chief Financial Officer. Myles will continue in his current roles until March 15, 2025, after which he will serve as a Senior Advisor to the company through September 15, 2025.

As part of his separation agreement, Myles will receive nine months of base salary, a bonus for the fiscal year ended December 31, 2024, a prorated portion of $202,400 based on his 2025 employment duration, and nine months of continued health benefits.