APOLLO readout in Q4 2026 is the next major catalyst; monitor for enrollment updates or interim analysis. Positive data would likely drive significant upside; failure would be severely negative. Consider positioning ahead of APOLLO results.
Price Chart
Executive Summary
Disc Medicine announced alignment with the FDA that the ongoing Phase 3 APOLLO study, if successful, can serve as the basis for responding to the CRL for bitopertin in EPP and potentially support traditional approval. This provides a clearer path forward after the CRL, reducing regulatory uncertainty. APOLLO data is expected in Q4 2026, with an FDA decision by mid-2027.
Key Facts
- FDA aligned that successful Phase 3 APOLLO study can support CRL response and potentially traditional approval.
- APOLLO data expected in Q4 2026; CRL response submission by end of 2026.
- FDA decision on bitopertin expected by mid-2027.
- Bitopertin is a potential first disease-modifying therapy for EPP.
Financial Impact
Reduced regulatory risk; potential for approval by mid-2027 could unlock significant revenue for bitopertin in EPP.
Risk Factors
- APOLLO may fail to meet endpoints, leading to approval delay or denial.
- Competition from other EPP treatments or alternative therapies.
- Regulatory setbacks or additional CRL items
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3308825 |
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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