Short answer
Scholar Rock Holding Corp (SRRK) filed its fiscal 2025 10-K annual report with the SEC on Mar 3, 2026. It reported revenue of $0 and net income of −$378M.
- Top risk flagged: FDA CRL September 2025 for apitegromab due to third-party fill-finish facility GMP deficiencies, delaying BLA resubmission and potential commercialization
FY2025 key financial metrics · XBRL
- Revenue
- $0
- Net income
- −$378M
- −53.5% YoY
- EPS (diluted)
- −$3.29
- −33.2% YoY
- ROE
- -154.0%
- −87.1 pp YoY
- Operating cash flow
- −$300M
- −49.3% YoY
Source: XBRL data from the Scholar Rock Holding Corp (SRRK) FY2025 10-K on SEC EDGAR. USD.
Scholar Rock Holding Corp FY2025 10-K analysis
AI summary of each section, grounded in the filing text
Business Overview
- Core business: Biopharmaceutical company developing selective monoclonal antibodies targeting latent growth factors for rare neuromuscular diseases
- New products emphasized: Apitegromab subcutaneous formulation and SRK-439 anti-latent myostatin antibody, both in clinical development in 2026
- Strategic shift: Transitioning to global commercial-stage biotech; appointed new CEO and expanded U.S./European commercial teams (~50 employees)
- Notable metric: Submitted BLA for apitegromab in SMA in Jan 2025; received FDA Priority Review and EMA MAA acceptance in March 2025
- Unique fact: Apitegromab is first myostatin inhibitor with positive Phase 3 SAPPHIRE study outcome and plans to target additional indications including infants under 2 years and FSHD
Management Discussion & Analysis
- Net loss $377.9M in 2025 vs $246.3M in 2024, operating expenses up 52.6% to $384.6M from $252.1M
- R&D expense $208.4M (+12.9%), G&A expense $176.2M (+161.0%), driven by commercial launch prep for apitegromab
- Apitegromab R&D costs rose 14.7% to $89.8M; SRK-181 decreased 75.8%, SRK-439 decreased 22.9%
- Cash, cash equivalents, and securities $367.6M at 2025 YE, down $69.7M YoY; net cash used in operations $300.0M
- Raised $91.7M from ATM stock sales, $50M from debt facility, $63.8M from warrant exercises in 2025
- FDA CRL for apitegromab due to third-party fill-finish issues; resubmission pending resolution, Phase 2 trial in FSHD planned mid-2026
- Management expects ongoing substantial expenses for R&D, commercialization, and infrastructure build ahead of potential apitegromab launch
Risk Factors
- FDA CRL September 2025 for apitegromab due to third-party fill-finish facility GMP deficiencies, delaying BLA resubmission and potential commercialization
- Geopolitical risk: EMA MAA review may be delayed or rejected due to mutual recognition of FDA’s OAI classification of the manufacturing site
- Supply chain risk: reliance on limited third-party manufacturers for materials, with potential interruptions or quality issues impacting clinical/commercial supplies
- Competitive risk: dependence on continued availability of approved SMN-targeted treatments (e.g., nusinersen, risdiplam) for apitegromab trials; limited access could halt trials
- Financial risk: ongoing net losses and urgent need for additional capital to fund development and commercialization of apitegromab, SRK-181, SRK-439
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