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Tuesday, Scholar Rock (NASDAQ:SRRK) shares are in focus following Truist Securities’ reiteration of a Buy rating and a $45.00 price target. The company, currently valued at $3.15 billion, has seen remarkable momentum with a 292.68% surge over the past six months. According to InvestingPro data, analyst targets range from $45 to $57, suggesting potential upside from current levels. The firm’s positive stance is bolstered by the recent announcement that the U.S. Food and Drug Administration (FDA) has granted priority review for apitegromab’s Biologics License Application (BLA). Additionally, the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for apitegromab for the treatment of spinal muscular atrophy (SMA).
The FDA has scheduled a Prescription Drug User Fee Act (PDUFA) date for apitegromab on September 22, 2025, aligning with the earlier end of expectations for the fourth quarter of 2025. The priority review designation is indicative of the FDA’s view that apitegromab may offer substantial improvements in the treatment of SMA compared to existing therapies.
Truist Securities highlighted the continued evidence of apitegromab’s efficacy, which is expected to support its approval by the FDA and other international regulatory bodies. Scholar Rock is preparing for a commercial launch in the U.S. market in the fourth quarter of 2025 and in the European Union in 2026.
The firm’s analysis suggests that peak sales for apitegromab in treating SMA could reach $1.5 billion, which is conservative compared to the consensus estimate of $1.8 billion. InvestingPro analysis shows the company maintains a strong balance sheet with more cash than debt, and a healthy current ratio of 9.61, providing adequate resources for the commercial launch phase. Scholar Rock’s upcoming milestones include the Phase 2 EMBRAZE proof-of-concept topline data in the second quarter of 2025, the Investigational New Drug (IND) filing for SRK-439 in the third quarter of 2025, the initiation of the SMA trial (OPAL) for patients under two years old also in the third quarter of 2025, and the anticipated U.S. commercial launch following the PDUFA date in September 2025. Investors should note that the company’s next earnings report is scheduled for May 8, 2025. For deeper insights into Scholar Rock’s financial health and growth prospects, including 8 additional ProTips and comprehensive valuation metrics, check out the detailed Pro Research Report available on InvestingPro.
In other recent news, Scholar Rock reported a significant earnings miss for Q4 2024, with actual earnings per share (EPS) of -$2.47, falling short of the forecasted -$0.58. Despite this, the company is optimistic about its future, driven by anticipated product launches and strategic developments. Scholar Rock is preparing for a potential commercial launch of its SMA treatment, apitegromab, in Q4 2025, pending FDA approval, with a European launch planned for 2026. The FDA has granted priority review for apitegromab, with a decision expected by September 22, 2025. Concurrently, the European Medicines Agency is reviewing the company’s Marketing Authorization Application for the same treatment. Additionally, Scholar Rock has granted inducement equity awards to seven new employees, as part of its efforts to attract new talent. These developments highlight the company’s strategic focus on product innovation and market expansion in the biopharmaceutical sector.
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