CAMBRIDGE, Mass. - Scholar Rock (NASDAQ: SRRK), a biopharmaceutical company, announced today the commencement of the Phase 2 EMBRAZE trial for its drug candidate apitegromab, focusing on obesity treatment. The trial aims to evaluate the safety and efficacy of the myostatin inhibitor in preserving lean muscle mass in obese individuals undergoing a specific background therapy.
The EMBRAZE trial, a randomized, double-blind, placebo-controlled study, will also explore apitegromab's role in maintaining weight loss after the cessation of GLP-1 receptor agonist therapy. The trial's primary goal is to assess changes in lean mass from baseline at week 24, using dual-energy X-ray absorptiometry. Secondary objectives include additional weight loss measures and pharmacokinetic outcomes.
Concurrently, Scholar Rock presented new preclinical data at the American Diabetes Association's 84th Scientific Sessions, demonstrating SRK-439's potential to increase lean mass and improve body composition after withdrawal from GLP-1 RA treatment. These findings suggest that SRK-439 could offer a differentiated approach to weight management.
Apitegromab, a fully human monoclonal antibody, selectively targets the pro- and latent forms of myostatin in skeletal muscle. Previously proven in clinical trials for spinal muscular atrophy, apitegromab has received Fast Track, Orphan Drug, and Rare Pediatric Disease designations from the FDA, as well as PRIME and Orphan Medicinal Product designations from the EMA.
SRK-439 is a novel, investigational myostatin inhibitor, optimized for treating cardiometabolic disorders, including obesity. It is distinct in its high selectivity for myostatin without affecting other related proteins.
Scholar Rock's portfolio aims to address diseases with significant unmet needs by modulating protein growth factors. The company's approach has yielded a pipeline poised to potentially improve the standard of care in various conditions.
This article is based on a press release statement from Scholar Rock.
In other recent news, Scholar Rock has been the focus of multiple analyst reports. BMO Capital Markets increased its price target for Scholar Rock shares to $31, maintaining an Outperform rating in anticipation of the upcoming Phase 3 SAPPHIRE trial results. The trial, slated for release in the fourth quarter of 2024, is designed to assess the efficacy of apitegromab.
Concurrently, BMO Capital Markets and Piper Sandler have maintained favorable ratings for Scholar Rock, with BMO sustaining an Outperform rating and a $29.00 price target, while Piper Sandler reaffirmed its Overweight rating with a steady price target of $28.00.
The company has made significant strides in the biopharmaceutical sector with a series of promising developments, including positive data from a Phase 1 trial of SRK-181, a drug designed to address resistance to certain cancer therapies.
Despite not currently generating revenue, with estimates projecting $0 for both 2023 and 2024 but anticipating $90 million in 2025, Scholar Rock has maintained investor interest. The company's cash reserves, standing at $238 million at the end of the last quarter, ensure the continuity of its research and development endeavors.
These recent developments spotlight Scholar Rock's ongoing efforts in the biopharmaceutical sector.
InvestingPro Insights
As Scholar Rock embarks on its Phase 2 EMBRAZE trial, the company's financial health and stock performance are critical factors for potential investors to consider. According to InvestingPro data, Scholar Rock holds a market capitalization of $673.92 million. The company's Price/Earnings (P/E) ratio currently stands at -3.66, reflecting investor sentiment about its future profitability prospects.
From a stock performance perspective, Scholar Rock has experienced significant volatility, with a 1 month price total return of -20.81% and a 3 month price total return of -48.44%. This trend underscores the company's recent challenges in the market.
Two notable InvestingPro Tips for Scholar Rock include the company's cash position relative to its debt, suggesting a degree of financial stability, and the indication from the Relative Strength Index (RSI) that the stock may be in oversold territory, which could interest value investors searching for potential rebounds.
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