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 participation in the 39th Annual J.P. Morgan Healthcare Conference on January 11, 2021, at 5:20 p.m. ET. The event will feature a live webcast accessible through the Investors & Media section of their website. An archived version of the presentation will be available for about 90 days after. Scholar Rock focuses on developing innovative therapies targeting protein growth factors for serious conditions like neuromuscular disorders, cancer, fibrosis, and anemia.
Scholar Rock (NASDAQ: SRRK), a clinical-stage biopharmaceutical company, announced its participation in two upcoming virtual investor conferences. The Jefferies Virtual London Healthcare Conference is scheduled for November 19, 2020, at 1:45 pm ET, with a live webcast available on the company's website. Additionally, Scholar Rock will participate in the Piper Sandler 32nd Annual Virtual Healthcare Conference from November 30 to December 3, 2020. The company focuses on discovering innovative treatments targeting protein growth factors for serious diseases.
Scholar Rock Holding Corporation (Nasdaq: SRRK) has successfully closed an underwritten public offering of 3,717,948 shares of common stock and pre-funded warrants to purchase 2,179,487 shares. The public offering price was set at $39.00 per share, raising approximately $230 million in gross proceeds. The funds will support the clinical development of SRK-015 for Spinal Muscular Atrophy and SRK-181 in cancer immunology, alongside further corporate purposes. This offering was facilitated by J.P. Morgan, Jefferies, and Credit Suisse.
Scholar Rock Holding Corporation (Nasdaq: SRRK) has priced an underwritten public offering of 2,948,718 shares of its common stock at $39.00 each, raising approximately $200 million in gross proceeds. Alongside, it offers pre-funded warrants to purchase 2,179,487 shares at $38.9999 each. The offering, which includes a 30-day option for underwriters to purchase an additional 769,230 shares, aims to fund the advancement of SRK-015 and SRK-181 for spinal muscular atrophy and cancer immunotherapy, along with general corporate purposes. The expected closing date is November 2, 2020.
Scholar Rock Holding Corporation (Nasdaq: SRRK) announced plans for a public offering of $150 million in common stock, with an additional $22.5 million option for underwriters. The funds will support clinical trials for SRK-015 in Spinal Muscular Atrophy and SRK-181 in cancer immunotherapy, alongside preclinical and general corporate purposes. The offering is subject to market conditions and is managed by J.P. Morgan, Jefferies, and Credit Suisse. The shares are offered under an SEC shelf registration. There are no guarantees regarding the offering's completion or terms.
Scholar Rock (NASDAQ: SRRK) announced positive six-month interim results from the TOPAZ Phase 2 trial of SRK-015 for patients with Type 2 and Type 3 Spinal Muscular Atrophy (SMA). All cohorts showed improvements in Hammersmith scale scores, with Cohort 3's high-dose group achieving a mean improvement of 5.6 points from baseline. 67% of patients saw at least a one-point improvement. Importantly, there were no safety signals reported. These results underscore SRK-015's potential as the first muscle-directed therapy for SMA, paving the way for future trials and regulatory discussions.
Scholar Rock (NASDAQ: SRRK) has successfully closed a $50 million debt facility with Silicon Valley Bank and Oxford Finance LLC, with an initial funding of $25 million. The funding aims to support general corporate purposes, including advancing their clinical pipeline and pre-commercialization preparations. The second tranche of $25 million is accessible upon certain clinical milestones. This financing is intended to enhance Scholar Rock's financial flexibility as it approaches significant clinical read-outs for its product candidates targeting serious diseases, such as SRK-015 and SRK-181.
Scholar Rock (NASDAQ: SRRK), a biopharmaceutical company, announced two poster presentations at the World Muscle Society 2020 Virtual Congress. The posters will cover clinical development data for SRK-015, an investigational therapy for Type 2 and Type 3 Spinal Muscular Atrophy (SMA), detailing findings from a Phase 1 trial and the ongoing Phase 2 TOPAZ trial. The TOPAZ trial is fully enrolled, with an interim analysis expected in Q4 2020. SRK-015 has received Orphan Drug and Rare Pediatric Disease designations, though its safety and efficacy remain unestablished.