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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) presented new data from its Phase 1 DRAGON trial of SRK-181, a selective inhibitor of latent TGFβ1 activation, in combination with pembrolizumab at the ASCO 2024 Annual Meeting. The study showed promising objective response rates (ORR) in various tumor types for patients resistant to anti-PD-(L)1 therapies. Clear cell renal cell carcinoma (ccRCC) patients exhibited a doubling of the ORR, suggesting a potential patient selection strategy. SRK-181 was generally well tolerated, with no Grade 5 treatment-related adverse events. These findings bolster confidence in SRK-181's ability to overcome immune checkpoint inhibitor-associated resistance. Scholar Rock plans to discuss these results further with the FDA.
Scholar Rock (NASDAQ: SRRK) will present new data from the Phase 1 DRAGON trial of SRK-181 in combination with pembrolizumab at the ASCO Annual Meeting, May 31 – June 4 in Chicago. The trial demonstrated encouraging responses and tolerability in patients with advanced solid tumors, including ccRCC, HNSCC, melanoma, and UC. It also showed that the SRK-181 + pembrolizumab combination improved the proinflammatory microenvironment. A positive correlation between CD8+ T cell infiltration and response rate was observed in ccRCC patients. An oral presentation of the data is scheduled for June 3 at 1:50 p.m. CDT, followed by a conference call on June 4 at 8 a.m. EDT.
Scholar Rock (NASDAQ: SRRK) has initiated the Phase 2 EMBRAZE trial to evaluate the efficacy and safety of apitegromab in preserving lean muscle mass in obese individuals on GLP-1 receptor agonist therapy. The trial involves 100 participants and will last 24 weeks, with primary results expected by mid-2025.
New preclinical data revealed SRK-439's superior performance over anti-ActRII antibodies in preserving lean mass in diet-induced obesity mice. SRK-439 showed significant lean mass preservation at lower doses compared to anti-ActRII, indicating its potential as a best-in-class treatment for obesity-related muscle mass preservation.
The company shared these findings at an Investor Event, emphasizing the advantage of selective latent myostatin inhibition. Future data presentations and an anticipated IND filing for SRK-439 in 2025 are planned.
Scholar Rock (NASDAQ: SRRK), a late-stage biopharmaceutical company, announced its participation in several upcoming investor conferences in June. The events include: UBS Obesity Therapeutics Day on May 23 at 9:00 a.m. ET, Jefferies Global Healthcare Conference on June 6 at 2:00 p.m. ET in New York City, and the 45th Annual Goldman Sachs Global Healthcare Conference on June 13 at 9:20 a.m. ET in Miami, Florida. These conferences will feature various presentations and virtual chats, with live webcasts available on Scholar Rock's website and archived for replay for approximately 90 days.
Scholar Rock (NASDAQ: SRRK), a late-stage biopharmaceutical company, has announced inducement equity awards under Nasdaq Listing Rule 5635(c)(4).
The awards cover an aggregate of 102,150 shares, including 58,370 stock options and 43,780 restricted stock units. These grants are part of Scholar Rock's 2022 Inducement Equity Plan, aimed at attracting new talent.
The stock options have an exercise price of $13.64, with vesting schedules based on employee service. This news is part of Scholar Rock's ongoing efforts to advance treatments for serious diseases.
Scholar Rock (NASDAQ: SRRK) will host an Investor Day on May 22, 2024, starting at 8:30 a.m. ET in New York City. The event will feature presentations from the executive management team on their myostatin inhibition programs targeting spinal muscular atrophy (SMA) and obesity. Renowned experts Dr. Ania Jastreboff of Yale School of Medicine and Dr. Diana Castro of the Neurology & Neuromuscular Care Center will also provide insights. Participants can access a live webcast and slide presentation via Scholar Rock's website, with a replay available for 90 days.
Scholar Rock, a late-stage biopharmaceutical company focused on innovative treatments for SMA and cardiometabolic disorders, reported Q1 2024 financial results. They are on track to report Phase 3 SAPPHIRE trial data in Q4 2024. Initiating Phase 2 trial for apitegromab in obesity. Strong financial position with $238 million in cash. Positive clinical data presentations for SRK-181 and SRK-439.
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