Scholar Rock reported a net loss of $102.2 million for the quarter ended September 30, 2025, up from a $64.5 million loss a year earlier. Diluted earnings per share fell to $‑0.90, a 36 % worsening from $‑0.66 in Q3 2024. The broader loss reflects a $38.6 million increase in operating expenses, driven by higher research and development costs for the apitegromab program and a sharp rise in general and administrative spending related to launch‑readiness activities.
Revenue for the quarter was effectively zero, consistent with the company’s pre‑revenue, clinical‑stage status. Consensus estimates had projected a nominal $0.05 million in revenue, and the actual figure matched that expectation, underscoring that the company’s financial performance is dominated by investment rather than sales.
The earnings miss relative to analyst expectations—consensus estimates ranged from $‑0.84 to $‑0.8556—was largely due to the escalation in operating costs. With no revenue to offset these expenses, the company’s loss widened, and the diluted loss per share fell below the consensus range by $0.04 to $0.06, a miss of roughly 5 % to 6 %.
Management reiterated its focus on the apitegromab program, stating that the company will resubmit the Biologics License Application in 2026 after addressing FDA concerns. The company’s cash balance of $369.6 million as of September 30 provides a runway through 2027, giving management flexibility to fund ongoing research and commercial infrastructure development.
Investor sentiment surged following the announcement, driven primarily by a constructive FDA Type A meeting that clarified the path to resubmission and a planned addition of a second U.S. fill‑finish facility. The regulatory update de‑risks the apitegromab launch timeline, which investors view as the key catalyst for future revenue generation.
CEO David L. Hallal emphasized the company’s commitment to bringing apitegromab to patients, noting that “we are unwavering in our commitment to bring apitegromab, the world’s first muscle‑targeted treatment, to children and adults living with SMA.” He added that the company will add a second filler to its BLA file, a strategy that was always part of the plan to ensure manufacturing resilience.
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