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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) reported a net loss of $30.7 million for Q2 2021, compared to a $19.3 million loss in Q2 2020. Revenue increased to $4.6 million, driven by the Gilead collaboration.
The company highlighted progress in its pipeline, particularly with apitegromab in spinal muscular atrophy (SMA), showing improvements in motor function in the Phase 2 TOPAZ trial. A Phase 3 trial is expected by year-end. SRK-181 is progressing through the DRAGON trial aimed at overcoming resistance in solid tumors. Scholar Rock has $282 million in cash, supporting its ongoing clinical programs.
Scholar Rock (NASDAQ: SRRK) announced its participation in the 2021 Wedbush PacGrow Healthcare Conference on August 11, 2021, at 9:10 a.m. ET. Interested parties can access a live webcast through the Investors & Media section of its website. An archived version will be available for 90 days post-presentation. The company focuses on treating serious diseases related to protein growth factors, developing novel therapies for conditions such as neuromuscular disorders, cancer, and fibrosis. More information can be found at scholarrock.com.
Scholar Rock (NASDAQ: SRRK) has announced the departure of CEO Tony Kingsley and his resignation from the Board of Directors. Nagesh Mahanthappa, the company's founder, will serve as Interim CEO while a search for a permanent successor is conducted. The Board expresses confidence in Mahanthappa's experience to ensure a seamless leadership transition. Scholar Rock remains focused on advancing its clinical pipeline, including the Phase 3 trial for apitegromab in spinal muscular atrophy and the DRAGON Phase 1 trial for SRK-181.
Scholar Rock (NASDAQ: SRRK) announced an e-presentation of clinical results from the TOPAZ Phase 2 trial evaluating apitegromab for Type 2 and 3 spinal muscular atrophy (SMA). This presentation will occur at the Virtual 7th Congress of the European Academy of Neurology from June 19-22, 2021. The 12-month results show apitegromab's potential to improve motor function in non-ambulatory SMA patients already on nusinersen. Scholar Rock plans to initiate a Phase 3 trial by the end of 2021 to further investigate this therapy.
Scholar Rock (NASDAQ: SRRK) announced promising results from its TOPAZ Phase 2 trial for apitegromab, showing significant motor function improvements in Type 2 and 3 SMA patients. The trial revealed a 74% clinical improvement rate in non-ambulatory patients on nusinersen, with notable Hammersmith Functional Motor Scale Expanded (HFMSE) score increases. Apitegromab, a myostatin inhibitor, may complement existing SMA therapies. A Phase 3 trial is expected to begin by the end of 2021, further evaluating apitegromab's efficacy when combined with other treatments.
Scholar Rock (NASDAQ: SRRK) announced positive results from the Phase 2 TOPAZ trial of apitegromab for Type 2 and Type 3 spinal muscular atrophy (SMA). The trial demonstrated improved motor function in non-ambulatory patients already on SMN therapy. An oral presentation will occur on June 11, 2021, at the Cure SMA Annual Conference. With Fast Track and Orphan Drug designations from the FDA, Scholar Rock anticipates launching a Phase 3 trial by the end of 2021 to further evaluate apitegromab's efficacy in SMA patients.
Scholar Rock (NASDAQ: SRRK), a clinical-stage biopharmaceutical firm, announced participation in key investor conferences. Management will present at the Jefferies Virtual Healthcare Conference on June 2, 2021, at 11:00 a.m. ET, and the Goldman Sachs Annual Global Healthcare Conference on June 9, 2021, at 2:10 p.m. ET. Additionally, they'll be part of the BMO Biopharma Day: Rare Disease Panel on June 22, 2021, at 10:30 a.m. ET. Webcasts of these presentations can be accessed via the Scholar Rock website, with replays available for 90 days.
Scholar Rock (NASDAQ: SRRK) announced that the FDA has granted Fast Track designation for apitegromab, targeting Spinal Muscular Atrophy (SMA). This designation aims to expedite drug development for serious conditions. Scholar Rock plans to submit a rolling Biologic License Application if criteria are met. The company sees apitegromab as a potential first muscle-directed therapy for SMA, with promising results from the TOPAZ Phase 2 trial. The drug has also received other crucial designations from both the FDA and EMA, highlighting an urgent medical need for effective SMA treatments.
Scholar Rock (NASDAQ: SRRK) announced a presentation of its DRAGON Phase 1 trial for SRK-181 at the 2021 ASCO Annual Meeting, focusing on patients with solid tumors resistant to checkpoint inhibitors. The trial aims to assess the efficacy of SRK-181, a selective TGFβ1 inhibitor, in overcoming this resistance. The poster will detail the trial design and biomarker analysis. The presentation is scheduled for June 4, 2021, showcasing SRK-181's potential to enhance tumor response when combined with anti-PD-(L)1 therapy.
Scholar Rock (NASDAQ: SRRK) announced its Q1 2021 financial results and progress on pipeline programs. Revenue decreased to $4.7 million from $5.0 million year-over-year, while net loss increased to $27.7 million, or $0.76 per share. The company highlighted positive top-line data from the TOPAZ Phase 2 trial for apitegromab, showing significant motor function improvements in SMA patients. Scholar Rock plans to initiate a Phase 3 trial by year-end 2021. With $315 million in cash, the company is well-positioned to fund operations into 2023.