The BLA acceptance de-risks near-term regulatory path; focus on PDUFA date and any FDA reinspection classification within 90 days. EPS miss is secondary to pipeline progress. Monitor for CHMP opinion mid-2026 and FORGE study initiation.
Price Chart
Executive Summary
Scholar Rock reported Q1 2026 net loss of $0.83/share (vs consensus $0.78 miss), with no revenue. The key positive is FDA acceptance of apitegromab BLA with September 30, 2026 PDUFA date, and completion of Catalent Indiana reinspection. Cash $479.9M. The wider loss from increased commercial readiness spending is overshadowed by regulatory progress.
Key Financial Metrics
Key Facts
- Net loss $105.5M vs $74.7M YoY, EPS -$0.83 vs -$0.67 YoY
- EPS missed consensus of -$0.78 by 6.4%
- No revenue recorded for Q1 2026 or 2025
- FDA accepted apitegromab BLA; PDUFA date September 30, 2026
- FDA completed reinspection of Catalent Indiana; classification expected within 90 days
- Second fill-finish facility on track for commercial supply early Q3 2026
- Cash, cash equivalents, and marketable securities of $479.9M as of March 31, 2026
- Drew down $100M from debt facility and raised $98M net via ATM program
Financial Impact
Q1 2026 net loss $105.5M wider than $74.7M year-ago, driven by $28.4M increase in G&A (commercial launch prep)
Risk Factors
- FDA may not approve by PDUFA date if manufacturing issues persist
- Higher operating burn rate ahead of potential launch
- Dilution risk from ATM program (already $98M raised)
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 7 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001104659-26-056655 |
| Document: srrk-20260507xex99d2.htm | 0001104659-26-056655 |
| Document: srrk-20260507xex99d1.htm | 0001104659-26-056655 |
| Document: 0001104659-26-056655-index-headers.html | 0001104659-26-056655 |
| Document: 0001104659-26-056655-index.html | 0001104659-26-056655 |
| Document: 0001104659-26-056655.txt | 0001104659-26-056655 |
| 8-K Data (Synthetic) | 0001104659-26-056655 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Sep 15, 2026 5w ago | 8-K | $50.00 $49.49 | ▼ −1.03% | ▼ −1.36% | $41.61 (−16.78%) |
Sep 14, 2026 6w ago | 8-K | $51.85 $50.00 | ▼ −3.57% | ▼ −3.11% | $41.61 (−19.75%) |
Aug 6, 2026 11w ago | 8-K | $52.64 $52.92 | ▲ +0.53% | ▼ −0.08% | $41.61 (−20.95%) |
Jul 6, 2026 15w ago | Insider Cluster | $56.56 $56.03 | ▼ −0.94% | ▼ −0.63% | $41.61 (−26.43%) |
Jun 11, 2026 19w ago | Institutional Cluster | $44.69 $44.18 | ▲ +1.14% | ▲ +1.68% | $41.61 (+6.89%) |
May 7, 2026 24w ago | 8-K | $46.45 $48.39 | ▲ +4.18% | ▲ +3.35% | $41.61 (−10.42%) |
Apr 16, 2026 27w ago | Insider Cluster | $50.00 $49.96 | ▲ +0.08% | ▲ +1.29% | $41.61 (+16.78%) |
Apr 16, 2026 27w ago | Insider Cluster | $50.00 $49.96 | ▲ +0.08% | ▲ +1.29% | $41.61 (+16.78%) |
Mar 27, 2026 30w ago | Institutional Cluster | $42.60 $43.08 | ▲ +1.13% | ▲ +1.48% | $41.61 (−2.32%) |
US Market Status
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