IRON Disc Medicine Inc
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.
Actionable Insight
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.
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
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3308825 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
|
Jun 18, 2026
2d ago
|
144
| $70.82 awaiting T+1 | awaiting T+1 | — | $70.79 (−0.04%) |
|
Jun 12, 2026
8d ago
|
Press Release
| $67.99 $70.09 | ▲ +3.09% | ▲ +1.33% | $70.79 (+4.12%) |
|
Jun 9, 2026
11d ago
|
Press Release
| $68.34 $67.25 | ▼ −1.59% | ▼ −0.02% | $70.79 (+3.59%) |
|
Jun 1, 2026
19d ago
|
Press Release
| $71.97 $68.00 | ▼ −5.52% | ▼ −5.66% | $70.79 (−1.64%) |
|
May 5, 2026
6w ago
|
8-K
| $67.59 $68.65 | ▲ +1.57% | ▲ +0.18% | $70.79 (+4.73%) |
|
May 5, 2026
6w ago
|
Press Release
| $67.59 $68.65 | ▲ +1.57% | ▲ +0.18% | $70.79 (+4.73%) |
|
Apr 13, 2026
9w ago
|
Insider Cluster
| $68.46 $70.48 | ▼ −2.95% | ▼ −1.74% | $70.79 (−3.40%) |
|
Feb 26, 2026
16w ago
|
8-K
| $67.91 $66.62 | ▲ +1.90% | ▲ +1.45% | $70.79 (−4.24%) |
US Market Status
Subscribe to SecBot
Get Real-Time SEC Filing Intelligence
Comprehensive SEC filing analysis delivered the moment filings hit EDGAR. Sentiment scoring, impact analysis, and actionable insights for every material event.
Try SecBot Free Coming soon: SecBot Pro with alerts, watchlists, and API access