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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 has appointed Dr. Jay Backstrom as CEO-Elect, effective
Scholar Rock (NASDAQ: SRRK), a clinical-stage biopharmaceutical company, announced two upcoming presentations at major conferences on September 25-29, focusing on SRK-181, a selective inhibitor aimed at overcoming cancer therapy resistance. At the ACCP Annual Meeting, new pharmacokinetic data will be presented, while the World Clinical Biomarkers & CDx Summit will discuss biomarker strategies and early clinical data. These presentations will be available on Scholar Rock's website post-conference.
Scholar Rock (NASDAQ: SRRK) reported positive 24-month data from its Phase 2 TOPAZ trial, supporting apitegromab's potential for Spinal Muscular Atrophy (SMA) patients. The company is actively enrolling for its pivotal Phase 3 SAPPHIRE trial. Financially, Scholar Rock completed a $205 million direct offering, strengthening its balance sheet, while net loss widened to $44 million for Q2 2022, with revenues dropping to $0 from $4.6 million a year prior. R&D expenses increased due to higher clinical costs for apitegromab.
Scholar Rock (NASDAQ: SRRK) has appointed Dr. Srinivas Akkaraju, Founder and Managing General Partner at Samsara BioCapital, to its Board of Directors as an independent director. With over 20 years in biotechnology investment, Dr. Akkaraju brings extensive experience to the company as it develops its late-stage pipeline and discovery programs. His addition is anticipated to enhance Scholar Rock's strategic direction, particularly in advancing its therapeutic candidate for spinal muscular atrophy amid ongoing Phase 3 trials.
Scholar Rock (NASDAQ: SRRK) announced its participation in the ‘Muscle Beach’ panel at the 2022 Wedbush PacGrow Healthcare Conference on August 9, 2022, at 2:20 PM ET. This clinical-stage biopharmaceutical company focuses on developing treatments for serious diseases reliant on protein growth factors. A live webcast of the event will be available on their website, with an archived replay accessible for 90 days post-event.
Scholar Rock (NASDAQ: SRRK) announced new data on its selective TGFβ1 antibody, which inhibits proTGFβ1 activation linked to extracellular matrix proteins. This data shows reduced TGFβ1 signaling and fibrosis in preclinical models, suggesting a safe treatment for fibrotic diseases like Alport syndrome and scleroderma. The findings will be presented at the 2022 FASEB Science Research Conference in Ireland on July 21, highlighting Scholar Rock's innovative approach to treating serious diseases driven by protein growth factors.
Scholar Rock (NASDAQ: SRRK) announced a presentation on its ongoing SAPPHIRE Phase 3 trial for apitegromab, targeting spinal muscular atrophy (SMA), at the 17th International Congress on Neuromuscular Diseases in Brussels (July 5-9, 2022). The trial is designed for non-ambulatory Types 2 and 3 SMA patients. Approximately 156 participants aged 2-12 will receive apitegromab or placebo, with exploratory evaluation for 48 older patients. The FDA and EMA have granted expedited designations for apitegromab. The efficacy and safety remain to be established.
Scholar Rock (SRRK) has announced a registered direct offering to sell 16,326,530 shares of common stock and pre-funded warrants to purchase 25,510,205 shares, raising approximately
Scholar Rock (NASDAQ: SRRK) announced encouraging results from the Phase 2 TOPAZ trial extension, revealing sustained improvements in motor functions for non-ambulatory patients with Types 2 and 3 SMA after 24 months of apitegromab treatment. Key findings include a mean increase of 4.0 points in Hammersmith Functional Motor Scale-Expanded (HFMSE) scores and a 4.4 points increase excluding patients post-scoliosis surgery. No serious safety risks were reported. The company is actively enrolling patients in the pivotal Phase 3 SAPPHIRE trial.
Scholar Rock (NASDAQ: SRRK) announced the upcoming presentations of 24-month data from the Phase 2 TOPAZ trial of apitegromab at the Annual SMA Conference on June 15-19, 2022. The results focus on efficacy and safety outcomes for spinal muscular atrophy (SMA) Type II and III patients, along with insights from a real-world evidence study on treatment benefits. Scholar Rock’s CEO, Nagesh Mahanthappa, emphasized the significance of these findings in addressing the unmet needs in SMA treatment. A conference call will take place on June 17, 2022, to discuss these results further.
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