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), a clinical-stage biopharmaceutical company, announced its management will present at the Cowen 43rd Annual Health Care Conference.
The presentation is scheduled for Tuesday, March 7, 2023, at 12:50 p.m. ET. Investors can access a live webcast on the Scholar Rock website, with an archived replay available for 90 days post-presentation.
Scholar Rock focuses on developing innovative medicines targeting protein growth factors for critical diseases, including neuromuscular disorders and cancer, showcasing its proprietary platform for monoclonal antibody discovery.
Scholar Rock (NASDAQ: SRRK) announced the granting of inducement equity awards totaling 285,000 shares to two new employees. This includes stock options for 255,000 shares and restricted stock units (RSUs) for 30,000 shares. The awards, part of the 2022 Inducement Equity Plan, come with an exercise price of $10.00, which matches the closing stock price on February 13, 2023. Vesting will occur over a defined schedule, emphasizing the importance of employee retention and performance. Scholar Rock focuses on developing innovative therapies for serious diseases influenced by protein growth factors.
Scholar Rock (NASDAQ: SRRK) has appointed Tracey M. Sacco as Chief Commercial Officer. Sacco, with nearly two decades of biopharmaceutical experience, will lead all commercial activities, focusing initially on the potential launch of apitegromab, a Phase 3 candidate for spinal muscular atrophy (SMA). Dr. Jay Backstrom, CEO of Scholar Rock, expressed confidence in Sacco's expertise in building commercial organizations, which is critical as the company advances its Phase 3 SAPPHIRE trial. Sacco's background includes significant roles at notable companies like Acceleron Pharma and Genzyme, underscoring her capacity to drive successful product launches.
Scholar Rock (NASDAQ: SRRK) provided updates on its clinical programs, indicating pivotal Phase 3 SAPPHIRE trial enrollment completion expected in 2023. The DRAGON trial of SRK-181 is also advancing, showing early efficacy signals. The company anticipates sufficient cash runway into 2025, supported by a $205 million equity raise completed in June 2022, with current cash reserves around $315 million. Upcoming milestones include 36-month data from the Phase 2 TOPAZ trial and progress on preclinical assets targeting fibrosis and iron-restricted anemia.
Scholar Rock (NASDAQ: SRRK) has announced that management will present at the J.P. Morgan 41st Annual Healthcare Conference on January 10, 2023, at 1:30 p.m. PT (4:30 p.m. ET). Investors can watch the live webcast through the Scholar Rock website, with an archived version available for 90 days afterward. Scholar Rock focuses on developing innovative treatments for serious diseases influenced by protein growth factors, targeting conditions like neuromuscular disorders, cancer, and fibrosis.
Scholar Rock (NASDAQ: SRRK) granted equity awards to a new employee, Jing L. Marantz, as part of its 2022 Inducement Plan. Dr. Marantz received a stock option for 250,000 shares at an exercise price of $8.59, which will vest in increments starting on November 9, 2023. The Inducement Plan aims to attract new employees following a period of non-employment, complying with Nasdaq's requirements. This strategic move underscores Scholar Rock's growth initiatives in the biopharmaceutical sector focused on innovative treatments for serious diseases.
Scholar Rock (SRRK) reported its Q3 2022 financial results, revealing a net loss of $43.3 million or $0.55 per share, compared to a net loss of $37.5 million or $1.02 per share in Q3 2021. Revenue fell to $0 from $5.5 million in the previous year. Notable updates include positive 24-month TOPAZ trial data for apitegromab in spinal muscular atrophy and ongoing enrollment for the Phase 3 SAPPHIRE trial. The company amended its debt facility, adding $25 million in capacity and extending loan terms. Cash reserves stand at $343.7 million, expected to fund operations into 2025.
Scholar Rock (NASDAQ: SRRK) has released early data from its Phase 1 DRAGON trial of SRK-181, a selective TGFβ1 inhibitor targeting advanced cancer resistance to checkpoint therapy. Key findings include:
- All doses were well tolerated with no significant toxicities.
- Biomarker data showed consistent target engagement.
- Two confirmed partial responses were observed in patients with anti-PD-1 resistant clear cell renal cell carcinoma.
Enrollment in the trial's Part B is ongoing, with further data expected next year.
Scholar Rock (NASDAQ: SRRK) appointed Dr. Jing L. Marantz as Chief Medical Officer, bringing over 20 years of experience in neurology, hematology/oncology, and rare diseases. Dr. Marantz, previously of Krystal Biotech, will oversee clinical development including the Phase 1 DRAGON trial for SRK-181 and Phase 3 SAPPHIRE trial for apitegromab in spinal muscular atrophy (SMA). CEO Jay Backstrom noted her expertise will enhance the company’s innovative approach to targeting TGFβ growth factors.
Scholar Rock (NASDAQ: SRRK) announced its participation in two upcoming investor conferences. The first is the Guggenheim 4th Annual Neuro/Immunology Conference on November 15, 2022, from 2:10-2:35 p.m. ET. The second is the Piper Sandler 34th Annual Healthcare Conference on November 29, 2022, from 8:00-8:25 a.m. ET. Live webcasts can be accessed on the Scholar Rock website, with archived replays available for 90 days post-event. Scholar Rock focuses on innovative treatments for serious diseases involving protein growth factors.