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) has announced the presentation of interim data from the TOPAZ Phase 2 clinical trial of apitegromab at the 2021 MDA Virtual Clinical Conference. The study focuses on apitegromab, a selective myostatin inhibitor for treating Type 2 and Type 3 Spinal Muscular Atrophy (SMA). Interim data from the trial will be shared in both an oral presentation on March 18 and a virtual poster available from March 15-18. Full 12-month data is anticipated in Q2 2021. Apitegromab has received Orphan Drug Designation from the FDA and the European Commission.
Scholar Rock (NASDAQ: SRRK) reported its financial results for 2020, revealing a net loss of $86.5 million ($2.81 per share), up from a loss of $51.0 million in 2019. Revenue declined to $15.4 million, primarily from a collaboration with Gilead. The company remains focused on its clinical trials for apitegromab in SMA and SRK-181 in cancer immunotherapy. Notably, all patients in the TOPAZ trial completed treatment, with top-line data expected in Q2 2021. A new patent for apitegromab was issued, and the DRAGON trial is set to advance in 2Q21.
Scholar Rock (NASDAQ: SRRK) announced key promotions within its senior management team: Gregory Carven, Ph.D. becomes Chief Scientific Officer; Junlin Ho, J.D. as General Counsel and Corporate Secretary; and George Nomikos, M.D., Ph.D. as Senior Vice President, Medical and Clinical Sciences, and Head of the Muscle Therapeutic Area. CEO Tony Kingsley highlighted their contributions to clinical programs and expressed confidence in achieving significant milestones in 2023, including trial results for their lead candidates. The company is focused on innovative therapies targeting serious diseases.
Scholar Rock (NASDAQ: SRRK) announced participation at the 2021 TGFβ for Immuno-Oncology Drug Development Summit. On January 28, 2021, they will present preclinical data on SRK-181, a selective inhibitor of TGFβ1, showing its potential to enhance the effects of checkpoint inhibitor therapy. The presentation indicates improved tumor growth control and a favorable toxicity profile. SRK-181 is currently undergoing a Phase 1 trial aimed at patients with advanced solid tumors, but it has not yet been approved by the FDA.
Scholar Rock (NASDAQ: SRRK) provided a corporate update, emphasizing significant clinical and operational progress in 2020. The company announced positive interim data from the TOPAZ trial demonstrating the potential of apitegromab for spinal muscular atrophy (SMA). Key milestones for 2021 include top-line efficacy and safety data from the TOPAZ Phase 2 trial anticipated in 2Q21 and initial clinical data from the DRAGON Phase 1 trial for SRK-181 expected in the second half of 2021. The company maintains a strong financial position to support operations into 2023.
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.
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