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Scholar Rock Holding Corporation develops biologic therapies for spinal muscular atrophy and other rare, severe, and debilitating neuromuscular diseases through its myostatin biology platform. Its principal program, apitegromab, is an anti-myostatin therapy being developed for children and adults with SMA, and its pipeline also includes subcutaneous apitegromab and SRK-439.
Recurring company updates include FDA regulatory activity for apitegromab, manufacturing and fill-finish matters tied to the program, quarterly financial results, cash and financing activity such as debt and at-the-market equity programs, and Nasdaq inducement equity grants for new employees. Scholar Rock also reports investor-conference participation and pipeline commentary related to anti-myostatin biology.
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 March 13-16, 2022. The company will present findings from the exploratory analysis of the Phase 2 TOPAZ trial focused on apitegromab, an investigational myostatin inhibitor for spinal muscular atrophy (SMA). Key results indicate a correlation between motor function improvements and the presence of scoliosis or joint contractures in patients. The poster will be presented in-person and virtually, with details available on the conference website.
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.
Scholar Rock has initiated the pivotal Phase 3 SAPPHIRE clinical trial for apitegromab, targeting non-ambulatory patients with Type 2 and 3 spinal muscular atrophy (SMA). The company has advanced to Part B of the DRAGON Phase 1 study for SRK-181, which seeks to address checkpoint inhibitor resistance in various cancers. Following the conclusion of its partnership with Gilead, Scholar Rock regained rights to its preclinical assets. The company ended 2021 with approximately $253 million in cash and equivalents.
Scholar Rock (NASDAQ: SRRK), a clinical-stage biopharmaceutical company, will present at the 40th Annual J.P. Morgan Healthcare Conference on January 11, 2022, at 7:30 a.m. ET. The presentation can be accessed via a live webcast on their website, with an archived replay available for 90 days. Scholar Rock focuses on developing innovative treatments targeting serious diseases related to protein growth factors. Their proprietary platform aims to create monoclonal antibodies that selectively target these signaling proteins, addressing challenges in therapeutic development.
Scholar Rock has announced the design of the SAPPHIRE trial, a pivotal Phase 3 study for apitegromab, targeting non-ambulatory Type 2/3 spinal muscular atrophy (SMA). This randomized, double-blind trial aims to evaluate the drug's efficacy in approximately 156 patients aged 2-12, with results informed by positive insights from the prior TOPAZ trial. Patients will be treated for 12 months, with a primary endpoint assessing changes in the Hammersmith Functional Motor Scale (HFMSE). SAPPHIRE is set to commence across 55 global sites, addressing a significant unmet medical need in SMA treatment.
Scholar Rock (NASDAQ: SRRK) announced the initiation of Part B of the DRAGON Phase 1 trial for SRK-181, a TGFβ1 inhibitor, following supportive results from Part A. The trial aims to overcome resistance to anti-PD-(L)1 therapies in patients with advanced solid tumors. Initial data revealed no dose-limiting toxicities, and preliminary efficacy results showed stable disease in several patients. Part B will include multiple tumor cohorts, with early efficacy data expected in 2022.
Scholar Rock (NASDAQ: SRRK) reported Q3 2021 results, revealing a net loss of $37.5 million ($1.02 per share), up from a loss of $23.6 million ($0.79) a year earlier. Revenue reached $5.5 million, driven by a collaboration with Gilead. Key updates include the upcoming initiation of a Phase 3 trial for apitegromab in non-ambulatory Type 2 and 3 SMA patients and progress in the DRAGON trial for SRK-181. Additionally, a U.S. patent for SRK-181 extends protection to May 2040, enhancing its market position.