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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) 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.
Scholar Rock (NASDAQ: SRRK) announced its management will present at the Jefferies Healthcare Conference on June 9, 2022, at 8:00 a.m. ET. The presentation will be available via live webcast in the Investors & Media section of the Scholar Rock website. An archived replay will be accessible for 90 days after the event. Scholar Rock is a clinical-stage biopharmaceutical company focused on developing innovative treatments targeting protein growth factors for serious diseases like neuromuscular disorders and cancer.
Scholar Rock (NASDAQ: SRRK) has provided an update and financial results for Q1 2022, reporting a net loss of $8.0 million, improved from $27.7 million a year earlier, with revenue rising to $33.2 million driven by a Gilead collaboration. The company is restructuring to reduce operating expenses by approximately 25% and extend its cash runway into Q4 2023. Key clinical trials for apitegromab and SRK-181 remain a priority. The Phase 3 SAPPHIRE trial is ongoing, and two-year data from the Phase 2 TOPAZ trial will be presented soon.
Scholar Rock (NASDAQ: SRRK) announced a podium presentation at the 14th European Paediatric Neurology Society (EPNS) Congress in Glasgow, UK, from April 28 - May 2, 2022. The presentation titled Apitegromab in Spinal Muscular Atrophy (SMA) will analyze multiple efficacy endpoints from the 12-month TOPAZ Phase 2 trial on patients with Types 2 and 3 SMA. The data will be presented by Dr. Thomas Crawford on May 1, highlighting apitegromab's potential in improving motor function for SMA patients.
Scholar Rock (NASDAQ: SRRK) announced the presentation of encore data at the American Academy of Neurology Annual Meeting, focusing on apitegromab's efficacy in spinal muscular atrophy (SMA).
The e-poster covers multiple efficacy endpoints from the 12-month TOPAZ Phase 2 trial, showcasing results such as the Hammersmith scales and Revised Upper Limb Module function. The presentation occurs on April 6, 2022, with data previously shared at the World Muscle Society Congress in September 2021. Apitegromab is a selective myostatin inhibitor under evaluation and has received FDA and EMA designations.
Scholar Rock (NASDAQ: SRRK) has announced its participation in the 2022 Muscular Dystrophy Association Clinical & Scientific Conference from
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