Welcome to our dedicated page for Scholar Rock Holding news (Ticker: SRRK), a resource for investors and traders seeking the latest updates and insights on Scholar Rock Holding stock.
News about Scholar Rock Holding Corporation (NASDAQ: SRRK) focuses on its progress as a late-stage biopharmaceutical company in neuromuscular diseases, particularly spinal muscular atrophy (SMA). Company announcements highlight clinical, regulatory, financial, and corporate developments tied to its myostatin biology platform and lead investigational therapy, apitegromab.
Investors and followers of SRRK can expect regular updates on the regulatory path for apitegromab, including interactions with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Recent press releases describe a Biologics License Application (BLA) for apitegromab, a Complete Response Letter related to a third-party fill-finish facility, a subsequent Type A meeting with the FDA, and ongoing EMA review of a Marketing Authorisation Application. News items also cover disease awareness and launch readiness activities in the United States and Europe.
Scholar Rock’s news flow also includes clinical trial milestones across its pipeline. Examples include dosing in the Phase 2 OPAL study in infants and toddlers with SMA, plans for the FORGE Phase 2 trial in facioscapulohumeral muscular dystrophy (FSHD), completion of a subcutaneous apitegromab Phase 1 study, and initiation of a Phase 1 trial of SRK-439 in healthy volunteers. These updates provide insight into the company’s broader anti-myostatin program and expansion into additional rare, severe, and debilitating neuromuscular diseases.
Financial and corporate news for SRRK features quarterly financial results, cash runway commentary, equity offerings under at-the-market programs, and inducement equity grants to new employees under the 2022 Inducement Equity Plan. Scholar Rock also issues announcements about participation in major healthcare conferences and investor events. For readers tracking SRRK stock and the company’s evolution as a late-stage biopharmaceutical organization, this news page aggregates these developments in one place.
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 $205 million. The shares and warrants are priced at $4.90 and $4.8999 respectively. The proceeds will fund ongoing clinical programs, including apitegromab and SRK-181, as well as the development of their technology platform. The offering is anticipated to close on June 22, 2022. Lead placement agent is J.P. Morgan Securities LLC.
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 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.