The FDA alignment on the APOLLO trial design significantly de-risks bitopertin. Focus on Q4 2026 topline data from APOLLO and upcoming initial data from DISC-3405 (RESTORE-PV) in Q3 2026 as key catalysts. Monitor cash burn rate and any PDUFA timeline updates.
Price Chart
Executive Summary
Disc Medicine reported Q2 2026 net loss of $59.5M ($1.54/share), slightly narrower than the $1.58 consensus. The key news is the completion of a Type A meeting with the FDA, aligning that the Phase 3 APOLLO study of bitopertin in EPP, if successful, can serve as the basis for a CRL response. The company also completed enrollment for the RESTORE-PV Phase 2 study of DISC-3405, with initial data now expected in Q3 2026, ahead of schedule. Cash position remains strong at $718M, providing runway into 2029.
Key Financial Metrics
Key Facts
- Completed Type A meeting with FDA: successful Phase 3 APOLLO can support CRL response for bitopertin in EPP; topline data expected Q4 2026
- Completed enrollment for RESTORE-PV Phase 2 study of DISC-3405 in polycythemia vera; initial data now expected Q3 2026
- Cash, cash equivalents, and marketable securities of $717.7M as of June 30, 2026, providing runway into 2029
- Net loss for Q2 2026 was $59.5M, net loss per share $(1.54) vs consensus $(1.58) – a 2.5% beat
- Launched Expanded Access Program (EAP) for bitopertin in EPP patients
- Presented positive Phase 2 data for selcodebart (DISC-0974) in myelofibrosis anemia at ASCO and EHA
Financial Impact
Pre-revenue clinical-stage biotech; net cash burn of ~$59.5M in Q2; cash runway into 2029 covers all planned trials. The FDA alignment de-risks the bitopertin program, which could address a significant unmet need in EPP if approved.
Risk Factors
- Phase 3 APOLLO trial failure or underwhelming results
- Regulatory setbacks or delays in CRL response
- Clinical trial enrollment or data delays for DISC-3405 and selcodebart
- Cash burn rate may accelerate with multiple concurrent trials
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 6 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001193125-26-325031 |
| Document: iron-20260730.htm | 0001193125-26-325031 |
| Document: 0001193125-26-325031-index-headers.html | 0001193125-26-325031 |
| Document: 0001193125-26-325031-index.html | 0001193125-26-325031 |
| Document: 0001193125-26-325031.txt | 0001193125-26-325031 |
| 8-K Data (Synthetic) | 0001193125-26-325031 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Sep 10, 2026 22d ago | 8-K | $74.14 $69.18 | ▼ −6.69% | ▼ −6.19% | $64.48 (−13.03%) |
Sep 9, 2026 22d ago | Press Release | $74.14 $69.18 | ▼ −6.69% | ▼ −6.19% | $64.48 (−13.03%) |
Sep 3, 2026 28d ago | Insider Cluster | $79.23 $68.92 | ▲ +13.01% | ▲ +11.80% | $64.48 (+18.62%) |
Sep 2, 2026 29d ago | 144 | $79.37 $70.06 | ▼ −11.73% | ▼ −10.58% | $64.48 (−18.76%) |
Aug 27, 2026 5w ago | Insider Cluster | $82.55 $79.37 | ▼ −3.85% | ▼ −4.12% | $64.48 (−21.89%) |
Aug 18, 2026 6w ago | Insider Cluster | $80.32 $82.67 | ▲ +2.93% | ▲ +3.31% | $64.48 (−19.72%) |
Aug 14, 2026 6w ago | Insider Cluster | $80.05 $80.94 | ▲ +1.11% | ▲ +2.30% | $64.48 (−19.45%) |
Jul 30, 2026 9w ago | 8-K | $79.21 $77.44 | ▼ −2.23% | ▼ −5.86% | $64.48 (−18.60%) |
Jul 30, 2026 9w ago | Press Release | $79.21 $77.44 | ▼ −2.23% | ▼ −5.86% | $64.48 (−18.60%) |
Jul 14, 2026 11w ago | Insider Cluster | $76.02 $74.32 | ▼ −2.24% | ▼ −1.26% | $64.48 (−15.18%) |
US Market Status
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