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Scholar Rock Holding Corporation (SRRK) is a biotechnology company dedicated to pioneering a novel class of biologic therapies known as 'niche modulators'. These therapies selectively target the activation of growth factors within the disease microenvironment, offering a groundbreaking approach to treating serious medical conditions. Scholar Rock's initial proprietary and partnered drug discovery programs focus on specific growth factors, particularly members of the TGF-beta superfamily, which are critical in regulating cell growth and differentiation. These growth factors are notably present in the microenvironments of significant diseases like fibrosis, musculoskeletal disorders, and autoimmune diseases.
The company’s innovative therapeutic strategy stems from the foundational scientific discoveries of its founders, Professors Timothy Springer, PhD, and Leonard Zon, MD, from Children's Hospital Boston and Harvard Medical School. These discoveries illuminate the molecular mechanisms of growth factor activation, empowering Scholar Rock to advance its ground-breaking treatments.
Scholar Rock is backed by a consortium of top-tier life sciences investors, including Polaris Partners and Arch Venture Partners. Its flagship product candidate, Apitegroma, is a selective, fully human, monoclonal antibody that inhibits the activation of the growth factor myostatin in skeletal muscle. This innovative mechanism holds promise for treating neuromuscular disorders. Another key product in the company's pipeline is SRK-181, which targets the activation of latent transforming growth factor beta-1 (TGFβ1) and is being developed to treat cancers that are resistant to existing anti-PD-(L)1 antibody therapies.
With its operations based in the United States, Scholar Rock continues to make significant strides in the biopharmaceutical industry, pushing the envelope of medical science and offering hope for effective treatments against some of the most challenging diseases.
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.
Scholar Rock (NASDAQ: SRRK) announced participation at the 2021 TGFβ for Immuno-Oncology Drug Development Summit. On January 28, 2021, they will present preclinical data on SRK-181, a selective inhibitor of TGFβ1, showing its potential to enhance the effects of checkpoint inhibitor therapy. The presentation indicates improved tumor growth control and a favorable toxicity profile. SRK-181 is currently undergoing a Phase 1 trial aimed at patients with advanced solid tumors, but it has not yet been approved by the FDA.
Scholar Rock (NASDAQ: SRRK) provided a corporate update, emphasizing significant clinical and operational progress in 2020. The company announced positive interim data from the TOPAZ trial demonstrating the potential of apitegromab for spinal muscular atrophy (SMA). Key milestones for 2021 include top-line efficacy and safety data from the TOPAZ Phase 2 trial anticipated in 2Q21 and initial clinical data from the DRAGON Phase 1 trial for SRK-181 expected in the second half of 2021. The company maintains a strong financial position to support operations into 2023.
Scholar Rock (NASDAQ: SRRK), a clinical-stage biopharmaceutical company, announced its participation in the 39th Annual J.P. Morgan Healthcare Conference on January 11, 2021, at 5:20 p.m. ET. The event will feature a live webcast accessible through the Investors & Media section of their website. An archived version of the presentation will be available for about 90 days after. Scholar Rock focuses on developing innovative therapies targeting protein growth factors for serious conditions like neuromuscular disorders, cancer, fibrosis, and anemia.
Scholar Rock (NASDAQ: SRRK), a clinical-stage biopharmaceutical company, announced its participation in two upcoming virtual investor conferences. The Jefferies Virtual London Healthcare Conference is scheduled for November 19, 2020, at 1:45 pm ET, with a live webcast available on the company's website. Additionally, Scholar Rock will participate in the Piper Sandler 32nd Annual Virtual Healthcare Conference from November 30 to December 3, 2020. The company focuses on discovering innovative treatments targeting protein growth factors for serious diseases.
Scholar Rock Holding Corporation (Nasdaq: SRRK) has successfully closed an underwritten public offering of 3,717,948 shares of common stock and pre-funded warrants to purchase 2,179,487 shares. The public offering price was set at $39.00 per share, raising approximately $230 million in gross proceeds. The funds will support the clinical development of SRK-015 for Spinal Muscular Atrophy and SRK-181 in cancer immunology, alongside further corporate purposes. This offering was facilitated by J.P. Morgan, Jefferies, and Credit Suisse.
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