Scholar Rock Holding Corp (NASDAQ:SRRK) Reports Q2 2025 Wider Loss but Market Shows Optimism Ahead of Key FDA Decision

Scholar Rock Holding Corp (NASDAQ:SRRK) Reports Q2 2025 Results: Wider Loss Than Expected, Market Reacts Positively

Scholar Rock Holding Corp posted a net loss of $110 million, or $0.98 per share, for the second quarter of 2025, missing analyst estimates of a $0.68 loss per share. Revenue remained at $0, in line with expectations, as the company continues to focus on advancing its lead candidate, apitegromab, through regulatory review and commercialization preparations.

Despite the larger-than-expected loss, the stock saw a modest pre-market gain of approximately 2%, suggesting investor optimism around upcoming milestones, including the FDA’s Prescription Drug User Fee Act (PDUFA) target action date of September 22, 2025, for apitegromab in spinal muscular atrophy (SMA). The company’s cash position of $295 million is expected to fund operations into 2027, providing a runway beyond potential regulatory approval.

Key Financial Takeaways

• EPS Miss: Reported a loss of $0.98 per share vs. an estimated loss of $0.68.
• Revenue In Line: No revenue recorded, matching expectations.
• Increased Spending: R&D expenses rose to $62.4 million (up from $42.4 million YoY), driven by drug supply manufacturing and leadership transition costs. G&A expenses surged to $49.7 million (from $17.1 million YoY) due to stock-based compensation and commercial launch preparations.
• Cash Position: $295 million in cash and equivalents, expected to sustain operations into 2027.

Market Reaction: Optimism Despite Wider Loss

The stock’s positive pre-market movement indicates that investors are looking beyond the quarterly loss and focusing on the upcoming PDUFA date and potential commercialization of apitegromab. The broader neuromuscular disease pipeline, including expansion into Duchenne muscular dystrophy (DMD) and obesity-related muscle preservation, also appears to be a factor in maintaining investor confidence.

Business Highlights from the Quarter

• Apitegromab (SMA): The FDA has accepted the Biologics License Application (BLA) under priority review, with a decision expected by September 22. European validation for the Marketing Authorisation Application (MAA) is also progressing, with a potential 2026 launch.
• Phase 2 EMBRAZE Trial (Obesity): Positive data showed apitegromab preserved lean mass during weight loss, opening potential cardiometabolic applications.
• Pipeline Expansion: Plans to initiate a Phase 2 trial (OPAL) in SMA for infants and toddlers, alongside preclinical development of SRK-439 for neuromuscular diseases.

Looking Ahead

Analyst estimates for Q3 2025 project a loss of $0.70 per share, with full-year 2025 revenue expectations at $5.41 million. The company did not provide explicit guidance, but commercialization readiness and regulatory milestones remain the focal points for the remainder of the year.

For more detailed earnings estimates and future projections, visit Scholar Rock’s earnings page.

Disclaimer: This article is for informational purposes only and does not constitute investment advice.