Disc Medicine, Inc.
IRON evidence brief
What we can confirm
What it means
What to watch
Prepared research question
What matters most for IRON—catalysts, financial risk and supporting evidence?
Traceable citations · Unknowns marked
BioSniper AI · IRON
Disc Medicine, Inc. (IRON) is a clinical-stage biopharmaceutical company developing first-in-class therapeutics targeting fundamental pathways of red blood cell biology, specifically heme biosynthesis and iron homeostasis, for hematologic diseases [sec · filed 2026-04-28].
Key risk: Regulatory approval risk
BioSniper Score
Based on 6 of 6 signals
Market Cap
$3.07B
Cash Runway
46.9 moLead Asset
bitopertin (Phase 3)
Next Catalyst
Phase3_Topline · Oct 1, 2026Financial data as of Jun 30, 2026.
Tracking 3 pipeline candidates · 10 clinical trials · 3 catalysts for Disc Medicine, Inc..
Disc Medicine, Inc. (IRON) is a clinical-stage biopharmaceutical company developing first-in-class therapeutics targeting fundamental pathways of red blood cell biology, specifically heme biosynthesis and iron homeostasis, for hematologic diseases [sec · filed 2026-04-28].
- Lead candidate bitopertin (GlyT1 inhibitor) targets erythropoietic protoporphyria (EPP) and X-linked protoporphyria (XLP); NDA accepted by FDA with priority review [sec · filed 2026-04-28].
- Cash and equivalents of $98.9M as of 2026-06-30 [sec]; company expects operating runway into 2029 [sec · filed 2026-04-28].
- Phase 3 topline data for bitopertin in EPP/XLP (APOLLO study) expected around 2026-10-01 [upcoming catalysts].
- Net loss of -$59.5M for the six months ended 2026-06-30 [sec]; accumulated deficit and ongoing R&D spending drive need for future capital [sec_mda · as of 2026-07-30].
- Shareholders' equity of $739.8M and total debt of $59.3M as of 2026-06-30 [sec].
What works
- Bitopertin has received FDA acceptance of its NDA with a priority review voucher, potentially shortening the review timeline to 1–2 months [sec · filed 2025-10-20].
- The company has built key processes and infrastructure to support commercial launch readiness for bitopertin [sec · filed 2026-04-28].
- Cash runway is projected into 2029, providing financial flexibility through key clinical milestones [sec · filed 2026-04-28].
What to weigh
- The company has a history of net losses and expects expenses to increase as it advances clinical trials and prepares for commercialization [sec_mda · as of 2026-07-30].
- Future capital requirements are uncertain and may require additional financing, particularly if the company pursues additional indications or geographies [sec_mda · as of 2026-07-30].
- The company's success depends on regulatory approval and commercial adoption of bitopertin, which is subject to clinical and regulatory risks [sec · filed 2025-10-22].
From the filings
Quoted directly from source documents.
Bitopertin NDA accepted with priority review
“New drug application (NDA) for bitopertin in erythropoietic protoporphyria (EPP) and X-linked protoporphyria (XLP) accepted by the U.S.”
SEC filings · April 28, 2026
Cash runway into 2029
“Obtained financing to provide runway into 2029 (+8%)”
SEC filings · April 28, 2026
Company expects increasing expenses
“We expect our expenses to continue to increase in connection with our ongoing activities, particularly as we continue the research and development of, initiate and complete clinical trials of, and seek regulatory approval for, our product candidates.”
SEC MD&A · July 30, 2026
Catalyst timeline
- 2026-10-01 · Phase3_Topline · bitopertin — Phase 3 Topline: APOLLO: A Randomized, Double-Blind, Placebo-Controlled Study of Bitopertin to Evaluate the Efficacy — Topline data from the pivotal Phase 3 APOLLO study will determine efficacy and safety of bitopertin in EPP/XLP.
- 2028-06-01 · Phase3_Topline — Phase 3 Topline: HELIOS: An Open-Label, Long-Term Study to Investigate the Safety, Tolerability, and Efficacy of DISC — Long-term safety and efficacy data from the HELIOS open-label study will support potential label expansion.
- 2028-11-24 · Phase3_Topline · single-level — Phase 3 Topline: A Prospective, Randomized, Double-Blinded, Sham-Controlled, Multicenter Study to Evaluate the Safety — This sham-controlled study will evaluate safety and efficacy for a separate indication (likely single-level lumbar fusion).
Risks & what to watch (4)›
Key risks
- Regulatory approval risk — Bitopertin's NDA is under FDA review; any delay or denial would significantly impact the company's prospects [sec · filed 2025-10-20].
- Clinical trial risk — Phase 3 topline data (APOLLO) expected in 2026; negative results could halt development [upcoming catalysts].
- Financing risk — Ongoing net losses and rising R&D costs may require additional capital, potentially diluting shareholders [sec_mda · as of 2026-07-30].
- Commercialization risk — If approved, bitopertin must achieve market adoption; company has no prior commercial experience [sec · filed 2026-04-28].
What to watch
- Phase 3 topline data for bitopertin in EPP/XLP (APOLLO study) expected around 2026-10-01 [upcoming catalysts].
- FDA decision on bitopertin NDA; priority review could yield action in late 2025 or early 2026 [sec · filed 2025-10-20].
- Initiation and progress of Phase 1b clinical trial in sickle cell disease (SCD) [sec · filed 2026-04-28].
- Cash burn rate and any future financing activities as the company approaches commercialization [sec_mda · as of 2026-07-30].
Sources: SEC filings · SEC MD&A · Generated August 29, 2026 · How we verify sources →
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Evidence & data
Score breakdownBased on 6 of 6 signals · derived from public data
46.9 months
D/E 0.14 · 0% dilution
Lead: Phase 3
3 candidates
3 upcoming, next in ~32d
0 buys · 27 sells (180d)
Runway
Catalysts
Pipeline
Regulatory
Financials
Institutional Holdings
Source: SEC Form 13F · as of Mar 2026Institutional holders
203
Total value held
$2.48B
| Holder | Shares | Value |
|---|---|---|
| fmr llc | 5,586,894 | $357.2M |
| vanguard capital management llc | 2,750,860 | $175.9M |
| ra capital management, l.p. | 2,450,221 | $156.7M |
| blackrock, inc. | 2,273,831 | $145.4M |
| woodline partners lp | 1,916,562 | $122.5M |
| wellington management group llp | 1,735,376 | $111.0M |
| state street corp | 1,698,244 | $108.6M |
| tcg crossover management, llc | 1,341,862 | $85.8M |
| bvf inc/il | 1,272,312 | $81.4M |
| orbimed advisors llc | 1,067,550 | $68.3M |
Showing top 10 of 203 institutional holders of Disc Medicine, Inc.. Open the full 13F history after sign-in.
Short Interest
as of Apr 24, 2026- % of float
- 15.8%
- Days to cover
- 9.3
- Shares short
- 5,460,074
- Daily short volume
- -
Short percent of float and days-to-cover reflect reported short positioning. Daily short volume is the exchange-reported short share of a single day's trading volume and is noisier. See the most-shorted biotech ranking →
IRON short interestGovernance
Frequently asked questions
What is the AI investment thesis for Disc Medicine, Inc.?
Disc Medicine, Inc. (IRON) is a clinical-stage biopharmaceutical company developing first-in-class therapeutics targeting fundamental pathways of red blood cell biology, specifically heme biosynthesis and iron homeostasis, for hematologic diseases [sec · filed 2026-04-28].
What is Disc Medicine, Inc.'s lead drug candidate?
Disc Medicine, Inc.'s most advanced tracked candidate is bitopertin (Phase 3) for Erythropoietic protoporphyria (EPP), X-linked protoporphyria (XLP), and Diamond-Blackfan Anemia (DBA).
What is Disc Medicine, Inc.'s next catalyst?
Disc Medicine, Inc.'s next tracked catalyst is a Phase3_Topline event — "Phase 3 Topline: APOLLO: A Randomized, Double-Blind, Placebo-Controlled Study of Bitopertin to Evaluate the Efficacy," — expected October 1, 2026.
Who is the CEO of Disc Medicine, Inc.?
Dr. John D. Quisel Esq., J.D., Ph.D. is the chief executive officer of Disc Medicine, Inc. (IRON).
Where is Disc Medicine, Inc. headquartered?
Disc Medicine, Inc. (IRON) is headquartered in Watertown, MA, United States.
The AI overview and BioSniper Score are neutral, data-derived signals built from public SEC filings, ClinicalTrials.gov and FDA records — not investment advice.