Scholar Rock Holding CORP 8-K filings

Scholar Rock Holding Corporation has filed a prospectus supplement to offer up to $200 million in common stock through its at-the-market program, replacing a prior supplement.

Scholar Rock reported Q2 2026 results, highlighting progress on its apitegromab BLA with a potential FDA approval by September 30, 2026, and initiating a Phase 2 trial for FSHD.

Scholar Rock announced first quarter 2026 financial results, highlighting the FDA's acceptance of the apitegromab Biologics License Application for spinal muscular atrophy with a PDUFA date of September 30, 2026.

Scholar Rock Holding Corporation has resubmitted its Biologics License Application for apitegromab for spinal muscular atrophy to the FDA, anticipating a late September 2026 action date.

Scholar Rock reported Q4 and full-year 2025 financial results, provided updates on apitegromab's regulatory path, and secured a new $550 million debt facility.

Scholar Rock reported full-year 2025 financial results, provided an update on its apitegromab regulatory pathway, and secured a new $550 million debt facility.

Scholar Rock Holding Corporation announced preliminary cash of $365 million and strategic priorities for 2026, focusing on apitegromab regulatory approvals and pipeline advancement.

Scholar Rock's manufacturing partner, Catalent Indiana, received an FDA warning letter, impacting the apitegromab launch timeline.

Scholar Rock Holding Corporation announced a prospectus supplement for an at-the-market offering program to sell up to $200 million of common stock.

Scholar Rock reported third-quarter 2025 financial results, highlighted by progress in apitegromab's regulatory pathway and an extended cash runway into 2027.

The FDA has issued an 'official action indicated' classification for a Catalent Indiana facility owned by Novo Nordisk, potentially impacting Scholar Rock Holding Corporation.

Scholar Rock announced the FDA issued a Complete Response Letter for its apitegromab BLA for SMA, citing issues at a third-party manufacturing facility, not related to the drug's efficacy or safety.

Scholar Rock announced positive clinical trial results for apitegromab in SMA and obesity, with FDA priority review for SMA, alongside increased Q2 net loss and strong cash position.

Scholar Rock Holding Corporation announced positive Phase 2 EMBRAZE clinical trial data for apitegromab, demonstrating statistically significant preservation of lean mass during tirzepatide-induced weight loss.

Scholar Rock Holding Corporation announced the appointment of Deloitte & Touche LLP as its new independent registered public accounting firm for the fiscal year ending December 31, 2025, following a competitive selection process.

Scholar Rock Holding Corporation held its annual meeting, electing two Class I directors, approving executive compensation, and notably withdrawing the proposal to ratify Ernst & Young LLP as its independent auditor.

Scholar Rock announced its Q1 2025 financial results and highlighted key business progress, including the FDA's priority review of apitegromab for SMA and advancements in commercial readiness.

Ernst & Young LLP will not stand for re-election as Scholar Rock Holding Corporation's independent accounting firm, effective after the filing of the Form 10-Q for the quarter ending March 31, 2025.

Scholar Rock announced David Hallal as its new CEO, succeeding Jay Backstrom, and appointed three key leaders to scale the company for the anticipated global launch of apitegromab for Spinal Muscular Atrophy (SMA).

Scholar Rock Holding Corporation appoints Erin Moore as interim Principal Financial Officer and sets the date for its 2025 Annual Meeting of Stockholders.

Scholar Rock submitted its Biologics License Application (BLA) for apitegromab in the U.S. for spinal muscular atrophy (SMA) patients and anticipates a U.S. launch in Q4 2025.

Scholar Rock appoints Lisa Wyman as Chief Technical and Quality Officer and initiates a leadership transition, with the current COO/CFO departing in March 2025.

Scholar Rock presented at the J.P. Morgan Healthcare Conference, highlighting progress in their SMA program, expansion into new indications, and advancements in their cardiometabolic pipeline.

Scholar Rock is progressing its pipeline with regulatory submissions for apitegromab in SMA, clinical trial readouts in obesity, and continued development of its oncology and anemia programs.

Scholar Rock reported positive topline data from its Phase 3 SAPPHIRE trial for apitegromab in SMA, achieved its primary endpoint, and completed a $345 million public offering.

Biopharmaceutical company Scholar Rock Holding Corporation has upsized its public offering to $300 million, with proceeds earmarked for the commercialization of its lead drug candidate, apitegromab, and further development of its clinical pipeline.

Scholar Rock's apitegromab met its primary endpoint in a Phase 3 trial, showing statistically significant and clinically meaningful improvement in motor function for patients with spinal muscular atrophy.

Scholar Rock announced its second quarter 2024 financial results and provided updates on its clinical programs, including positive long-term data for its SMA treatment and progress in its obesity program.

Scholar Rock Holding Corporation's stockholders approved amendments to the company's charter, including increasing authorized shares and limiting officer liability, at their annual meeting on June 27, 2024.

Scholar Rock presented new preclinical data showing SRK-439, a myostatin inhibitor, preserves lean mass and attenuates fat rebound after GLP-1 receptor agonist withdrawal, and has dosed the first participants in a Phase 2 trial for apitegromab in obesity.