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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 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
Scholar Rock (SRRK) reported its financial results for 2021, highlighting a net loss of $131.8 million, or $3.59 per share, compared to a loss of $86.5 million the previous year. Revenue increased to $18.8 million, driven by a collaboration with Gilead. The company is focused on advancing its Phase 3 SAPPHIRE trial for apitegromab in spinal muscular atrophy, with results expected from the TOPAZ trial by mid-2022. Cash reserves stand at approximately $253 million, projected to sustain operations through mid-2023. Upcoming data from the DRAGON trial evaluating SRK-181 is also anticipated in 2022.
Scholar Rock (NASDAQ: SRRK) has announced its participation in an Orphan Neuro and Neuromuscular panel discussion at Cowen’s 42nd Annual Health Care Conference on March 7, 2022, at 9:10 a.m. ET. The event will be accessible via live webcast, with a replay available for 30 days thereafter. Scholar Rock focuses on developing innovative therapies targeting serious diseases influenced by protein growth factors. Its proprietary platform allows for the creation of monoclonal antibodies that selectively target signaling proteins in the disease microenvironment.
Scholar Rock (NASDAQ: SRRK), a clinical-stage biopharmaceutical company, announced a presentation at the 2nd Annual TGFβ for Immuno-Oncology Drug Development Summit, taking place from January 25-27, 2022. The presentation titled “Development of a Comprehensive Biomarker Strategy to Support DRAGON” will occur on January 27, 2022, at 11:00 AM EST. It will cover the biomarker strategy related to the SRK-181 Phase 1 trial, aimed at assessing its safety and efficacy in patients with advanced solid tumors, particularly in combination with anti-PD-(L)-1 therapies.
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