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Disc Medicine Receives Complete Response Letter for Bitopertin, Shifts to Traditional Approval Pathway
IRON
Guidance Update
Product Launch
- Disc Medicine received a Complete Response Letter (CRL) from the FDA for bitopertin, noting that while protoporphyrin IX (PP9) reductions were sufficient, the FDA had uncertainty about whether these reductions were "reasonably likely to predict a clinical benefit" for accelerated approval.
- The company plans to address the CRL by submitting results from the ongoing Phase 3 APOLLO study, which is expected to complete enrollment in March 2026 and provide top-line data in Q4 2026.
- The APOLLO trial design, featuring co-primary efficacy endpoints of PP9 reduction and improved sunlight tolerance, has been aligned with the FDA.
- Following resubmission with the APOLLO data, Disc Medicine anticipates an FDA decision on traditional approval by mid-2027.
- The CRL did not raise any Chemistry, Manufacturing, and Controls (CMC) or other issues, and the company has a cash runway into 2029.
Feb 17, 2026, 1:00 PM
Disc Medicine Provides Update on Bitopertin Regulatory Status
IRON
Product Launch
Guidance Update
- Disc Medicine received a Complete Response Letter (CRL) from the FDA for bitopertin, noting that while there was sufficient evidence of protoporphyrin IX (PP9) reduction, there was uncertainty regarding whether these reductions were "reasonably likely to predict a clinical benefit".
- The company expects top-line data from the Phase 3 APOLLO study in Q4 2026, which will measure both PP9 reduction and improvement in sunlight tolerance as co-primary efficacy endpoints to address the FDA's concerns.
- Disc Medicine anticipates an updated FDA decision in mid-2027 for traditional approval, following a planned resubmission after the APOLLO data becomes available.
- The CRL did not raise any CMC or other issues, and the company maintains a cash runway into 2029.
Feb 17, 2026, 1:00 PM
Disc Medicine Receives FDA Complete Response Letter for Bitopertin
IRON
- Disc Medicine received a Complete Response Letter (CRL) from the FDA on February 13, 2026, regarding its drug Bitopertin.
- The FDA's main objection centered on the sufficiency of protoporphyrin IX (PPIX) as a surrogate biomarker, requesting the outcome of the ongoing APOLLO study before making a decision.
- Disc Medicine plans to complete enrollment for the APOLLO study in March 2026 and expects to present topline data in Q4 2026 to support its response to the CRL.
- An updated FDA decision on Bitopertin is potentially expected by mid-2027 following the resubmission.
- The company remains well-capitalized with a cash runway guidance into 2029, covering the APOLLO readout and other key pipeline milestones.
Feb 17, 2026, 1:00 PM
Disc Medicine Receives FDA Complete Response Letter for Bitopertin
IRON
Guidance Update
New Projects/Investments
Product Launch
- Disc Medicine received a Complete Response Letter (CRL) from the FDA for bitopertin, with the FDA noting uncertainty about whether reductions in protoporphyrin IX (PP9) were "reasonably likely to predict a clinical benefit" for accelerated approval.
- The company plans to address the CRL using results from the ongoing Phase III APOLLO study, which is designed to measure PP9 reduction and improvement in sunlight tolerance as co-primary efficacy endpoints.
- Enrollment for the APOLLO trial will be completed in March (2026), with top-line data expected in Q4 this year (2026). Disc Medicine anticipates an updated FDA decision on a traditional approval basis around mid-2027.
- Disc Medicine also expects additional data from its Phase II myelofibrosis study for DISC-0974 and initial data from its Phase II study in Polycythemia Vera for DISC-3405 in the second half of this year (2026), and maintains a cash runway into 2029.
Feb 17, 2026, 1:00 PM
Disc Medicine Receives FDA Complete Response Letter for Bitopertin
IRON
Product Launch
Guidance Update
New Projects/Investments
- Disc Medicine, Inc. received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) on February 13, 2026, regarding its New Drug Application for bitopertin as a treatment for erythropoietic protoporphyria (EPP).
- The FDA's primary concern was the sufficiency of protoporphyrin IX (PPIX) as a surrogate biomarker, requesting the outcome of the ongoing APOLLO study before making a decision.
- Disc Medicine plans to complete enrollment for the APOLLO study by March 2026, with topline data expected in Q4 2026.
- The company intends to submit a response to the CRL by late 2026, anticipating a potential updated FDA decision by mid-2027.
- Disc Medicine is well-capitalized through the APOLLO readout and additional key pipeline milestones, maintaining cash runway guidance into 2029.
Feb 17, 2026, 12:42 PM
Disc Medicine Anticipates FDA Approval and Launch of Bitopertin, Highlights Strong Financial Position and Pipeline Progress
IRON
Product Launch
Guidance Update
New Projects/Investments
Jan 14, 2026, 11:00 PM
Disc Medicine Provides Update on Bitopertin Approval Timeline and Pipeline Progress
IRON
Product Launch
New Projects/Investments
Guidance Update
- Disc Medicine anticipates FDA approval for bitopertin for erythropoietic protoporphyria (EPP) by the end of January or early February 2026, following an accelerated review under the Commissioner's National Priority Voucher program.
- The company estimates a U.S. market of 14,000 diagnosed EPP patients, with 6,000 engaged patients, representing a potential $2 billion+ addressable market for bitopertin.
- Disc Medicine's pipeline includes DISC-0974 for anemias of inflammation (e.g., myelofibrosis, a $4 billion+ U.S. opportunity) and DISC-3405 for polycythemia vera (75,000 patients), with both programs targeting pivotal trials in 2027.
- The company reported $791 million in cash on hand as of year-end, providing a financial runway into 2029, which conservatively assumes no revenue from bitopertin.
Jan 14, 2026, 11:00 PM
Disc provides corporate overview and pipeline updates at 44th Annual Healthcare Conference
IRON
Product Launch
New Projects/Investments
Guidance Update
- Disc's lead product, Bitopertin, for Erythropoietic Protoporphyria (EPP) has its New Drug Application (NDA) under FDA review via an accelerated approval pathway, with potential FDA approval and launch anticipated in early 2026.
- The company's pipeline includes DISC-0974 for Anemia of Myelofibrosis and Inflammatory Bowel Disease, and DISC-3405 for Polycythemia Vera and Sickle Cell Disease, with multiple data catalysts and study initiations expected through 2026-2027.
- Disc projects significant market opportunities for its key programs, with addressable markets estimated at $2 billion+ for EPP, $4 billion+ for MF Anemia, and $7 billion+ for PV.
- As of December 31, 2025, Disc reported a preliminary unaudited cash, cash equivalents, and marketable securities balance of $791 million, providing a financial runway into 2029.
Jan 14, 2026, 11:00 PM
Disc Medicine Provides Update on Lead Program Approval and Pipeline at JPMorgan Healthcare Conference
IRON
Product Launch
New Projects/Investments
Guidance Update
- Disc Medicine's lead program, bitopertin, for erythropoietic protoporphyria (EPP), is anticipated to receive potential FDA approval in late January or early February 2026, with the company prepared for launch into a $2 billion+ U.S. market opportunity.
- The company is advancing its pipeline with DISC-0974 for myelofibrosis anemia, in late-stage Phase II development and expected to move to Phase III in 2027, targeting a $4 billion+ market opportunity.
- DISC-3405, aimed at polycythemia vera and sickle cell disease, is in a Phase II trial with significant data expected by the end of 2026, with pivotal trials projected for early 2027.
- Disc Medicine maintains a strong financial position with $791 million in cash on hand as of year-end, providing a runway into 2029 that accounts for all planned activities, including Phase III trials and commercial team build-out, without assuming bitopertin revenue.
Jan 14, 2026, 11:00 PM
Disc Medicine, Inc. Outlines 2025 Achievements and 2026 Milestones
IRON
Product Launch
New Projects/Investments
Guidance Update
- Disc Medicine, Inc. reported unaudited cash, cash equivalents, and marketable securities of $791 million as of December 31, 2025, providing a financial runway into 2029.
- The company's bitopertin NDA was submitted and accepted under an accelerated approval pathway with priority review and was awarded the Commissioner’s National Priority Voucher (CNPV), with an FDA approval decision anticipated in early 2026 for the treatment of EPP.
- Positive initial Phase 2 data from the RALLY-MF study of DISC-0974 for anemia of myelofibrosis was presented in 2025, with updated data expected in H2 2026.
- Initial data from the Phase 2 study of DISC-3405 in polycythemia vera (PV) and Phase 1b study in sickle cell disease (SCD) is expected in H2 2026.
Jan 12, 2026, 1:37 PM
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