Welcome to our dedicated page for Scholar Rock Holding news (Ticker: SRRK), a resource for investors and traders seeking the latest updates and insights on Scholar Rock Holding stock.
Scholar Rock Holding Corporation (SRRK) is a clinical-stage biopharmaceutical company pioneering targeted therapies that modulate growth factor activation in serious diseases. This page serves as the definitive source for official updates, including clinical trial progress, regulatory milestones, and strategic partnerships.
Investors and researchers will find curated news spanning SRRK's neuromuscular, oncology, and metabolic disorder pipelines. Content includes earnings reports, scientific presentations, and manufacturing updates—all essential for tracking the company's novel niche modulator platform.
Key focus areas include apitegromab in spinal muscular atrophy, obesity therapeutics, and fibrosis interventions. Updates are organized chronologically with clear sourcing to maintain transparency. Bookmark this page for streamlined access to SRRK's advancements in precision biologics.
Scholar Rock (NASDAQ: SRRK) announced the publication of Phase 1 trial results for apitegromab in the journal Advances in Therapy. Apitegromab, a selective myostatin inhibitor, aims to treat spinal muscular atrophy (SMA). Key findings include safety at doses up to 30 mg/kg and a 24-31 day half-life. Following positive Phase 2 results indicating improved motor function in Type 2 and Type 3 SMA, a Phase 3 trial is expected to start by the end of 2021. The FDA has granted Orphan Drug Designation and Rare Pediatric Disease designation for apitegromab.
Scholar Rock (NASDAQ: SRRK) announced the issuance of U.S. Patent No. 10,981,981, expiring in May 2034, covering methods for inhibiting myostatin activation. This patent supports the company’s proprietary platform that targets precursor growth factors. CEO Tony Kingsley highlighted the recent positive results from the TOPAZ Phase 2 trial for apitegromab, which aims to enhance motor function in spinal muscular atrophy (SMA) patients. The trial demonstrated significant potential for apitegromab as a first muscle-directed therapy for SMA.
Scholar Rock (NASDAQ:SRRK) announced a poster presentation at the AACR Annual Meeting 2021, detailing biomarker assays for its DRAGON Phase 1 trial of SRK-181, a selective TGFβ1 inhibitor. This investigational candidate targets patients with advanced solid tumors resistant to checkpoint inhibitors. The e-poster, titled “Development of a Comprehensive Biomarker Strategy to Support the Latent TGFβ1 Inhibitor SRK-181 Phase 1 Clinical Trial, DRAGON,” will be available for on-demand viewing starting April 10, 2021.
Scholar Rock (NASDAQ:SRRK) has announced positive top-line results from the 12-month TOPAZ Phase 2 trial for apitegromab, aimed at treating Type 2 and Type 3 spinal muscular atrophy (SMA). Key findings include a 0.3-point decline in the Revised Hammersmith Scale (RHS) for ambulatory patients, with 57% maintaining or improving motor function. Non-ambulatory patients showed a 0.6-point improvement in the Hammersmith Functional Motor Scale Expanded (HFMSE). Cohort 3 reported a 7.1-point mean improvement in HFMSE. No major safety concerns were raised, with ongoing studies planned for additional indications.
Scholar Rock (NASDAQ: SRRK) announced the publication of preclinical data for SRK-181 in the International Journal of Toxicology. SRK-181 is a potent inhibitor of latent TGFβ1, aimed at overcoming resistance to checkpoint inhibitor therapy, and is currently in the DRAGON Phase 1 trial for solid tumors. The publication details SRK-181’s pharmacology, pharmacokinetics, and safety, supporting its clinical evaluation. Promising preclinical findings indicate a potentially improved safety profile compared to non-selective TGFβ inhibitors, with further clinical results expected by year-end.
Scholar Rock (NASDAQ: SRRK) has appointed Joshua Reed as an independent director on its Board of Directors. Reed, with over two decades of biopharmaceutical experience, will also chair the audit committee. His background includes significant roles at Aldeyra Therapeutics and Bristol-Myers Squibb. The company emphasizes that Reed's operational and strategic expertise is crucial at this stage of its growth, particularly as it aims to advance innovative treatments for serious diseases such as spinal muscular atrophy and cancer. Reed expressed enthusiasm about joining the team to drive transformative milestones.
Scholar Rock (NASDAQ: SRRK) announced the issuance of U.S. Patent No. 10,946,036, expiring June 2037, which covers myostatin inhibitor and neuronal corrector therapy for Spinal Muscular Atrophy (SMA). CEO Tony Kingsley expressed enthusiasm for this patent, anticipating top-line results from the apitegromab TOPAZ Phase 2 trial next quarter. The patent claims are broad and also granted in Japan and Europe. SMA affects 30,000 to 35,000 patients in the U.S. and Europe, highlighting the need for new therapies addressing muscle atrophy.
Scholar Rock (NASDAQ: SRRK) has announced the presentation of interim data from the TOPAZ Phase 2 clinical trial of apitegromab at the 2021 MDA Virtual Clinical Conference. The study focuses on apitegromab, a selective myostatin inhibitor for treating Type 2 and Type 3 Spinal Muscular Atrophy (SMA). Interim data from the trial will be shared in both an oral presentation on March 18 and a virtual poster available from March 15-18. Full 12-month data is anticipated in Q2 2021. Apitegromab has received Orphan Drug Designation from the FDA and the European Commission.
Scholar Rock (NASDAQ: SRRK) reported its financial results for 2020, revealing a net loss of $86.5 million ($2.81 per share), up from a loss of $51.0 million in 2019. Revenue declined to $15.4 million, primarily from a collaboration with Gilead. The company remains focused on its clinical trials for apitegromab in SMA and SRK-181 in cancer immunotherapy. Notably, all patients in the TOPAZ trial completed treatment, with top-line data expected in Q2 2021. A new patent for apitegromab was issued, and the DRAGON trial is set to advance in 2Q21.
Scholar Rock (NASDAQ: SRRK) announced key promotions within its senior management team: Gregory Carven, Ph.D. becomes Chief Scientific Officer; Junlin Ho, J.D. as General Counsel and Corporate Secretary; and George Nomikos, M.D., Ph.D. as Senior Vice President, Medical and Clinical Sciences, and Head of the Muscle Therapeutic Area. CEO Tony Kingsley highlighted their contributions to clinical programs and expressed confidence in achieving significant milestones in 2023, including trial results for their lead candidates. The company is focused on innovative therapies targeting serious diseases.
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