IRON Disc Medicine Inc
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Executive Summary
Disc Medicine announced updated Phase 2 data for DISC-0974 in myelofibrosis anemia (55% major response in non-transfusion-dependent patients, 64% transfusion independence in low-burden TD) and sustained bitopertin PPIX reductions in EPP at EHA 2026. The company confirmed a Type A meeting with FDA where APOLLO Phase 3 data, due Q4 2026, can serve as basis for a CRL response and potentially support traditional approval. Initial DISC-3405 data in polycythemia vera also expected Q4 2026.
Actionable Insight
Traders should monitor APOLLO Phase 3 top-line results in Q4 2026 as the single most important binary catalyst — success would confirm the CRL-response path and likely drive a >8-15% rally for this early-stage biotech. The RALLY-MF data strengthen the DISC-0974 profile ahead of End-of-Phase 2 meetings, supporting a second pivotal program. DISC-3405 initial data in Q4 adds further optionality. The 75% T+20 win rate on prior IRON reports supports bullish positioning into this catalyst sequence.
Key Facts
- Phase 2 RALLY-MF: 55% of nTD patients achieved hemoglobin increase ≥1.5 g/dL for ≥12 weeks (major response)
- 64% of TD Low and 50% of TD High MF patients achieved transfusion independence over 12-16 weeks
- 56% of JAK inhibitor-concomitant patients achieved major hematologic response across transfusion groups
- HELIOS OLE: Sustained PPIX reductions and improved light tolerance with up to 2.5+ years bitopertin exposure
- Type A meeting confirmed APOLLO Phase 3 readout in Q4 2026 can serve as basis for CRL response and potentially support traditional approval
- RESTORE-PV Phase 2 initial data for DISC-3405 in polycythemia vera expected Q4 2026 — third program could enter pivotal development in 2027
- DISC-0974 well-tolerated; diarrhea was only related AE in ≥2 subjects, majority of AEs not related
Financial Impact
Disc Medicine has no revenue or earnings yet. The catalyst-rich H2 2026 hinges on APOLLO bitopertin Phase 3, which can potentially resolve the existing CRL and unlock a traditional approval for EPP (an orphan indication with no approved therapies) — value-driving for a $2.6B market cap biotech entirely dependent on pipeline success.
Risk Factors
- APOLLO Phase 3 failure would be severely bearish — bitopertin is the most advanced asset and a CRL is already outstanding; a miss could eliminate path-to-approval
- CRL on CMC or safety/efficacy grounds if APOLLO data are not clean + additional manufacturing/resolution risk before re-submission
- Clinical-stage biotech with no revenue — any pipeline setback (DISC-0974 regulatory delay, DISC-3405 early data miss) would erode premium valuation
- Broader biotech sentiment or financing risk — Disc may require equity raises to fund three programs
Market Snapshot
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3311034 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
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Jun 18, 2026
2d ago
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144
| $70.82 awaiting T+1 | awaiting T+1 | — | $70.79 (−0.04%) |
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Jun 12, 2026
8d ago
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Press Release
| $67.99 $70.09 | ▲ +3.09% | ▲ +1.33% | $70.79 (+4.12%) |
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Jun 9, 2026
11d ago
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Press Release
| $68.34 $67.25 | ▼ −1.59% | ▼ −0.02% | $70.79 (+3.59%) |
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Jun 1, 2026
19d ago
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Press Release
| $71.97 $68.00 | ▼ −5.52% | ▼ −5.66% | $70.79 (−1.64%) |
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May 5, 2026
6w ago
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8-K
| $67.59 $68.65 | ▲ +1.57% | ▲ +0.18% | $70.79 (+4.73%) |
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May 5, 2026
6w ago
|
Press Release
| $67.59 $68.65 | ▲ +1.57% | ▲ +0.18% | $70.79 (+4.73%) |
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Apr 13, 2026
9w ago
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Insider Cluster
| $68.46 $70.48 | ▼ −2.95% | ▼ −1.74% | $70.79 (−3.40%) |
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Feb 26, 2026
16w ago
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8-K
| $67.91 $66.62 | ▲ +1.90% | ▲ +1.45% | $70.79 (−4.24%) |
US Market Status
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