Disc Medicine, Inc.
IRON evidence brief
What we can confirm
- BioSniper Score:
- 4.9 / 10
- Market Cap:
- $2.65B
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 is a clinical-stage biopharmaceutical company developing novel treatments for serious hematologic diseases, with a focus on heme biosynthesis and iron homeostasis pathways.
Key risk: Bitopertin CRL and regulatory delay
BioSniper Score
Based on 2 of 6 signals
Limited data coverage
Market Cap
$2.65B
Cash Runway
—
Lead Asset
—
Next Catalyst
—
Financial data as of Jun 30, 2026.
Tracking 10 clinical trials for Disc Medicine, Inc..
Disc Medicine is a clinical-stage biopharmaceutical company developing novel treatments for serious hematologic diseases, with a focus on heme biosynthesis and iron homeostasis pathways.
- Bitopertin NDA for EPP and XLP accepted for priority review under accelerated approval pathway; awarded Commissioner's National Priority Voucher to accelerate review to 1-2 months [sec · filed 2026-04-28].
- Complete Response Letter issued for bitopertin in February 2026; company plans to submit a response after topline data from the APOLLO trial expected in Q4 2026 [sec_mda · as of 2026-07-30].
- Positive initial data from Phase 2 RALLY-MF study of DISC-0974 (selcodebart) for anemia of myelofibrosis, showing robust hematologic efficacy [sec · filed 2026-04-28].
- Phase 2 RESTORE-PV trial of DISC-3405 in polycythemia vera initiated June 2025; initial data expected Q3 2026 [sec_mda · as of 2026-07-30].
- Cash, cash equivalents and marketable securities of $717.7 million as of June 30, 2026, providing runway into 2029 [sec_mda · as of 2026-07-30].
What works
- Bitopertin has been granted priority review and a Commissioner's National Priority Voucher, potentially enabling a very rapid NDA review [sec · filed 2026-04-28].
- DISC-0974 has shown robust hematologic efficacy in a Phase 2 study and is protected by a composition-of-matter patent until 2041 [sec · filed 2026-04-28].
- The company has a strong cash position of $717.7 million as of June 30, 2026, providing financial runway into 2029 [sec_mda · as of 2026-07-30].
What to weigh
- Bitopertin received a Complete Response Letter from the FDA in February 2026, delaying potential approval [sec_mda · as of 2026-07-30].
- The company reported a net loss of $59.5 million for the six months ended June 30, 2026, reflecting ongoing high R&D and operational costs [latest reported financials].
- Dependence on successful clinical outcomes for multiple pipeline candidates, with no approved products generating revenue yet [sec_mda · as of 2026-07-30].
From the filings
Quoted directly from source documents.
Bitopertin NDA accepted for priority review with accelerated approval pathway
“New drug application (NDA) for bitopertin in erythropoietic protoporphyria (EPP) and X-linked protoporphyria (XLP) accepted by the U.S. Food and Drug Administration (FDA) for priority review under the accelerated approval pathway”
SEC filings · April 28, 2026
Complete Response Letter issued for bitopertin in February 2026
“Complete Response Letter issued February 2026”
Pipeline
Cash position of $717.7 million as of June 30, 2026
“As of June 30, 2026, we had cash, cash equivalents and marketable securities of $717.7 million.”
SEC MD&A · July 30, 2026
Positive initial data from Phase 2 RALLY-MF study of DISC-0974
“Positive initial data from the Phase 2 RALLY-MF study of DISC-0974 for anemia of MF, demonstrating robust and broad hematologic efficacy across patient segments”
SEC filings · April 28, 2026
Catalyst timeline
- 2022-06-06 · Phase 2 start of RALLY-MF (DISC-0974) in myelofibrosis — Trial evaluating safety and efficacy of DISC-0974 for anemia in myelofibrosis; initial positive data reported in 2025.
- 2022-10-31 · Phase 2 start of AURORA (bitopertin) in EPP — Randomized, double-blind, placebo-controlled study of bitopertin in EPP; supports NDA submission.
- 2023-04-04 · Phase 1 start of DISC-0974 in non-dialysis dependent chronic kidney disease — Phase 1b study evaluating safety, tolerability, PK/PD of DISC-0974 in CKD patients with anemia.
Risks & what to watch (4)›
Key risks
- Bitopertin CRL and regulatory delay — FDA issued a Complete Response Letter in February 2026, requiring additional data before approval [sec_mda · as of 2026-07-30].
- Clinical trial failure risk — Multiple pipeline candidates are in early- to mid-stage trials; failure in any could materially impact the company [sec_mda · as of 2026-07-30].
- No approved products or revenue — The company has no marketed products and relies on financing to fund operations, with net loss of $59.5M in H1 2026 [latest reported financials].
- Dependence on single lead asset — Bitopertin is the most advanced candidate; any setback would significantly affect the pipeline [sec · filed 2026-04-28].
What to watch
- Topline data from the APOLLO trial of bitopertin in EPP/XLP expected in Q4 2026 [sec_mda · as of 2026-07-30].
- Initial data from the Phase 2 RESTORE-PV trial of DISC-3405 in polycythemia vera expected in Q3 2026 [sec_mda · as of 2026-07-30].
- Initial data from the Phase 1b trial of DISC-3405 in sickle cell disease expected in Q4 2026 [sec_mda · as of 2026-07-30].
- FDA decision on bitopertin NDA after CRL response, anticipated by mid-2027 if APOLLO is successful [sec_mda · as of 2026-07-30].
Sources: Catalysts · News · Pipeline · SEC filings · SEC MD&A · Generated October 7, 2026 · How we verify sources →
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Evidence & data
Score breakdownBased on 2 of 6 signals · derived from public data
Pipeline inputs are unavailable for this score. It uses only the available signals shown below.
Cash runway data unavailable
D/E 0.14 · 0% dilution
No tracked pipeline phase
No tracked pipeline candidates
No upcoming catalysts tracked
0 buys · 21 sells (180d)
Regulatory
Financials
Institutional Holdings
Source: SEC Form 13F · as of Mar 2026Institutional holders
204
Total value held
$2.56B
| Holder | Shares | Value |
|---|---|---|
| fmr llc | 5,586,894 | $357.2M |
| ra capital management, l.p. | 2,450,221 | $156.7M |
| blackrock, inc. | 2,273,831 | $145.4M |
| wellington management group llp | 1,735,376 | $111.0M |
| state street corp | 1,698,244 | $108.6M |
| atlas venture life science advisors, llc | 1,513,875 | $96.8M |
| vanguard capital management llc | 1,375,430 | $87.9M |
| frazier life sciences management, l.p. | 1,354,852 | $86.6M |
| tcg crossover management, llc | 1,341,862 | $85.8M |
| jpmorgan chase & co | 1,371,480 | $83.4M |
Showing top 10 of 204 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 is a clinical-stage biopharmaceutical company developing novel treatments for serious hematologic diseases, with a focus on heme biosynthesis and iron homeostasis pathways.
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.
What therapeutic areas does Disc Medicine, Inc. focus on?
Disc Medicine, Inc. develops therapies across Oncology, Rare Disease, Immunology, Hematology, Nephrology.
The AI overview and BioSniper Score are neutral, data-derived signals built from public SEC filings, ClinicalTrials.gov and FDA records — not investment advice.