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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), a clinical-stage biopharmaceutical company, announces a late-breaking poster presentation at the 50th Child Neurology Society Annual Meeting held from September 29 to October 2, 2021, in Boston. The presentation focuses on the efficacy of Apitegromab in patients with later-onset Spinal Muscular Atrophy (SMA) Types 2 and 3, highlighting responder analyses from the Phase 2 TOPAZ study. The poster will be published in the 2021 Annals of Neurology supplement. Apitegromab has received multiple designations from the FDA and EMA, although its efficacy and safety are not yet established.
Scholar Rock (NASDAQ: SRRK) announced the issuance of U.S. Patent No. 11,130,803, expiring May 2040, for SRK-181, a selective TGFβ1 inhibitor aimed at treating patients resistant to checkpoint inhibitors like anti-PD-(L)1 therapies. This patent fortifies the company's intellectual property as it progresses in the DRAGON Phase 1 trial, which focuses on safety and effectiveness in various solid tumor types. Initial clinical data from the trial is expected by year-end, reinforcing Scholar Rock's commitment to developing innovative cancer treatments.
Scholar Rock (NASDAQ: SRRK) recently presented two posters at the World Muscle Society Virtual Congress from September 20-24, 2021. The presentations highlighted findings from the TOPAZ Phase 2 trial of apitegromab for treating Spinal Muscular Atrophy (SMA). Key results include improvements in various efficacy endpoints such as Hammersmith scales and Revised Upper Limb Module (RULM) scores among patients. This research supports the potential of apitegromab and sets the stage for a Phase 3 trial aimed at establishing it as a leading muscle-directed therapy for SMA by year-end 2021.
Scholar Rock (NASDAQ: SRRK), a clinical-stage biopharmaceutical company, has announced its upcoming presentation at the 2021 Cantor Virtual Global Healthcare Conference on September 29 at 11:20 a.m. ET. This event marks an opportunity for the company to showcase its innovative approach in treating serious diseases through targeted protein growth factors. Interested parties can access the live webcast via the Scholar Rock website, with an archived replay available for 90 days post-event.
Scholar Rock (NASDAQ: SRRK) announces the appointment of Caryn Parlavecchio as the new Chief Human Resources Officer. With over 20 years of experience in the biotechnology and pharmaceutical sectors, she will enhance the company's HR strategies and talent acquisition efforts. Interim CEO Nagesh Mahanthappa emphasized that her insights will be pivotal for Scholar Rock's growth as it moves towards late-stage development and commercialization. Parlavecchio previously served at Holy Name Medical and held significant roles at Novartis.
Scholar Rock (NASDAQ: SRRK) reported a net loss of $30.7 million for Q2 2021, compared to a $19.3 million loss in Q2 2020. Revenue increased to $4.6 million, driven by the Gilead collaboration.
The company highlighted progress in its pipeline, particularly with apitegromab in spinal muscular atrophy (SMA), showing improvements in motor function in the Phase 2 TOPAZ trial. A Phase 3 trial is expected by year-end. SRK-181 is progressing through the DRAGON trial aimed at overcoming resistance in solid tumors. Scholar Rock has $282 million in cash, supporting its ongoing clinical programs.
Scholar Rock (NASDAQ: SRRK) announced its participation in the 2021 Wedbush PacGrow Healthcare Conference on August 11, 2021, at 9:10 a.m. ET. Interested parties can access a live webcast through the Investors & Media section of its website. An archived version will be available for 90 days post-presentation. The company focuses on treating serious diseases related to protein growth factors, developing novel therapies for conditions such as neuromuscular disorders, cancer, and fibrosis. More information can be found at scholarrock.com.
Scholar Rock (NASDAQ: SRRK) has announced the departure of CEO Tony Kingsley and his resignation from the Board of Directors. Nagesh Mahanthappa, the company's founder, will serve as Interim CEO while a search for a permanent successor is conducted. The Board expresses confidence in Mahanthappa's experience to ensure a seamless leadership transition. Scholar Rock remains focused on advancing its clinical pipeline, including the Phase 3 trial for apitegromab in spinal muscular atrophy and the DRAGON Phase 1 trial for SRK-181.
Scholar Rock (NASDAQ: SRRK) announced an e-presentation of clinical results from the TOPAZ Phase 2 trial evaluating apitegromab for Type 2 and 3 spinal muscular atrophy (SMA). This presentation will occur at the Virtual 7th Congress of the European Academy of Neurology from June 19-22, 2021. The 12-month results show apitegromab's potential to improve motor function in non-ambulatory SMA patients already on nusinersen. Scholar Rock plans to initiate a Phase 3 trial by the end of 2021 to further investigate this therapy.
Scholar Rock (NASDAQ: SRRK) announced promising results from its TOPAZ Phase 2 trial for apitegromab, showing significant motor function improvements in Type 2 and 3 SMA patients. The trial revealed a 74% clinical improvement rate in non-ambulatory patients on nusinersen, with notable Hammersmith Functional Motor Scale Expanded (HFMSE) score increases. Apitegromab, a myostatin inhibitor, may complement existing SMA therapies. A Phase 3 trial is expected to begin by the end of 2021, further evaluating apitegromab's efficacy when combined with other treatments.
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