The stock is a binary PDUFA catalyst play. Monitor FDA advisory committee announcement and any update on the Catalent Indiana inspection classification, which could derail the September 30 PDUFA date. The $492M cash position provides runway through launch and into 2027.
Price Chart
Executive Summary
Scholar Rock reported Q2 2026 results in line with consensus: EPS of -$0.84 (0.3% beat vs -$0.84 consensus) and zero revenue, consistent with its pre-commercial stage. The filing's primary focus is the ongoing FDA review of the apitegromab BLA with a PDUFA date of September 30, 2026, and progress on a second fill-finish facility. Cash position strengthened to $492M, including $63M from ATM proceeds, extending runway through potential launch. The stock is driven entirely by the binary PDUFA outcome, not quarterly financials.
Key Financial Metrics
Key Facts
- Net loss per share was -$0.84 for Q2 2026, essentially flat vs -$0.98 in Q2 2025 (improvement driven by share count increase).
- No revenue recorded for Q2 2026 or Q2 2025; company remains pre-commercial.
- Cash, cash equivalents, and marketable securities of $492.1M as of June 30, 2026, up from $367.6M at Dec 31, 2025, including $62.8M in net ATM proceeds.
- Apitegromab BLA under FDA review with PDUFA date of September 30, 2026; second fill-finish facility data package submitted and under review.
- Phase 2 FORGE trial in FSHD initiated; Phase 1 SRK-439 study ongoing with topline data expected late 2026.
Financial Impact
No revenue; net loss of $109.9M in Q2 2026 vs $110.0M in Q2 2025. Cash burn rate ~$55M/quarter excluding ATM proceeds.
Risk Factors
- FDA non-approval or Complete Response Letter (CRL) for apitegromab BLA by September 30, 2026 PDUFA date
- Adverse FDA inspection classification of Catalent Indiana facility could delay or block approval
- Dilution from ATM program ($62.8M raised in Q2) may continue
- Competition from existing SMA therapies (Spinraza, Zolgensma, Evrysdi)
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 6 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001193125-26-336715 |
| Document: srrk-20260806.htm | 0001193125-26-336715 |
| Document: 0001193125-26-336715-index-headers.html | 0001193125-26-336715 |
| Document: 0001193125-26-336715-index.html | 0001193125-26-336715 |
| Document: 0001193125-26-336715.txt | 0001193125-26-336715 |
| 8-K Data (Synthetic) | 0001193125-26-336715 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Sep 15, 2026 5w ago | 8-K | $50.00 $49.49 | ▼ −1.03% | ▼ −1.36% | $41.27 (−17.46%) |
Sep 14, 2026 6w ago | 8-K | $51.85 $50.00 | ▼ −3.57% | ▼ −3.11% | $41.27 (−20.41%) |
Aug 6, 2026 11w ago | 8-K | $52.64 $52.92 | ▲ +0.53% | ▼ −0.08% | $41.27 (−21.60%) |
Jul 6, 2026 15w ago | Insider Cluster | $56.56 $56.03 | ▼ −0.94% | ▼ −0.63% | $41.27 (−27.03%) |
Jun 11, 2026 19w ago | Institutional Cluster | $44.69 $44.18 | ▲ +1.14% | ▲ +1.68% | $41.27 (+7.65%) |
May 7, 2026 24w ago | 8-K | $46.45 $48.39 | ▲ +4.18% | ▲ +3.35% | $41.27 (−11.15%) |
Apr 16, 2026 27w ago | Insider Cluster | $50.00 $49.96 | ▲ +0.08% | ▲ +1.29% | $41.27 (+17.46%) |
Apr 16, 2026 27w ago | Insider Cluster | $50.00 $49.96 | ▲ +0.08% | ▲ +1.29% | $41.27 (+17.46%) |
Mar 27, 2026 30w ago | Institutional Cluster | $42.60 $43.08 | ▲ +1.13% | ▲ +1.48% | $41.27 (−3.12%) |
US Market Status
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