Scholar Rock Holding Corporation
Scholar Rock Holding Corporation Q3 FY2025 earnings call
November 14, 2025 · fiscal period ended 2025-09
EPS · actual vs est
Revenue · actual vs est
Summary
Generated 2025-11-14
Management highlights
David Hallal mentioned confidence in Scholar Rock's potential as a global biotech powerhouse after new management appointment, APITEGROMAB's PDUFA date and CRL, Type A meeting with FDA, Novo Nordisk's remediation plan for Bloomington facility. Akshay Vaishnaw updated on APITEGROMAB R&D progress including II期OPAL trial initiation and SRK - 439's clinical development. Keith Woods discussed commercial launch strategy with SMA treatment centers and payers. Vikas Sinha shared third quarter financial results, cash position, adjusted operating plan and prioritized investments.
Segment performance
No specific product segment financial performance with absolute terms and revenue contribution % provided in detail
Guidance
Expect to resubmit BLA and launch in US in 2026, accelerate second fill/finish facility timeline, anticipate EMA's MAA decision for APITEGROMAB by mid - 2026, expect data from SRK - 439's Phase I study in 2026.
Risks
Risks include potential inspection failure of Bloomington facility, operational risks related to second fill/finish facility transition, and regulatory approval delays.
Q&A highlights
Q: Mani Foroohar asked about financing options and supply chain operational risk.
A: Vikas Sinha and David Hallal responded.
Q: Eric Schmidt inquired about confidence in Catalent's remediation and inspection class.
A: David Hallal and Akshay Vaishnaw answered.
Q: Tessa Romero questioned BLA submission path and EMA review.
A: David Hallal and Akshay Vaishnaw replied.
Q: Tazeen Ahmad asked about Catalent reinspection timeline and emergency switch.
A: David Hallal and Akshay Vaishnaw responded.
Q: Kripa Devarakonda asked about BLA resubmission timeline and Novo's external consultants.
A: David Hallal and Akshay Vaishnaw answered.
Q: Etzer Darout inquired about FDA resubmission timeline.
A: David Hallal and Akshay Vaishnaw replied.
Q: Marc Frahm asked about Catalent inspection disclosure.
A: David Hallal responded.
Q: Evan Seigerman asked about patient identification and uptake.
A: Keith Woods answered.
Key numbers
Reported versus consensus
Earnings calendar feed
| Metric | Reported | Consensus | Delta | Prior year |
|---|---|---|---|---|
| EPS | $-0.90 | $-0.84 | -7.8% | — |
| Revenue | — | $50,000 | — | — |
Transcript
November 14, 2025Full transcript unavailable for redistribution
The structured summary above covers the available call sections. Full transcript text is not included on this page.
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Prior quarters
This page presents the stored structured earnings-call summary and deterministic earnings calendar values. How this is generated. For informational purposes only; not investment advice.