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Disc Medicine Provides Update on Accelerated Bitopertin Approval and Pipeline Progress
IRON
Product Launch
New Projects/Investments
Guidance Update
Nov 19, 2025, 2:00 PM
Disc Medicine Provides Updates on Bitopertin, DISC-0974, and Financial Position
IRON
Product Launch
Guidance Update
New Projects/Investments
- Disc Medicine submitted an NDA for bitopertin for erythropoietic protoporphyria (EPP) at the end of September, with potential approval and launch by late 2025 or early 2026 due to an accelerated approval process and a national priority voucher.
- The company expects to present 40-50 patients' worth of data from its Phase 2 RALI-MF trial for DISC-0974 in anemia in myelofibrosis at ASH 2025, following positive data from 35 patients presented at ASH 2024.
- Disc Medicine has initiated a Phase 2 trial for its polycythemia vera program, with data expected in 2026 and a potential move to a pivotal trial within 12-18 months.
- The company's balance sheet holds approximately $825 million, providing a cash runway until 2029 without accounting for potential revenue.
Nov 19, 2025, 2:00 PM
Disc Medicine's Bidapertin Nears Accelerated Approval, Pipeline Advances, and Strong Financial Position Reported
IRON
Product Launch
Guidance Update
New Projects/Investments
- Disc Medicine submitted the NDA for its lead program, Bidapertin, for erythropoietic protoporphyria (EPP) at the end of September and received an FDA Commissioner's National Priority Voucher, accelerating the review time to one to two months after acceptance, with potential approval in December or January.
- Phase 2 data for Disc 974 in anemia of myelofibrosis will be presented at ASH this year, following extraordinary efficacy in the Phase 1B study. The first data readout for Disc 3405 in polycythemia vera is expected next year, with exploration also underway in sickle cell disease.
- The company recently completed a financing, resulting in a pro forma balance of approximately $820 million, providing a cash runway into 2029, which does not include potential Bidapertin revenues or PRV voucher sales.
Nov 13, 2025, 1:40 PM
Disc Medicine Updates on Bidapertin Approval Timeline, Pipeline Progress, and Financial Outlook
IRON
Product Launch
New Projects/Investments
Guidance Update
- Disc Medicine's lead program, Bidapertin, for erythropoietic protoporphyria (EPP), is on an accelerated FDA review pathway following its September NDA submission and receipt of a National Priority Voucher, with potential approval by December or January.
- The company anticipates presenting new Phase 2 data for Disc 974 in anemia of myelofibrosis at ASH this year and expects initial Phase 2 data for Disc 3405 in polycythemia vera and sickle cell disease next year.
- Following a recent financing, Disc Medicine holds approximately $820 million on its balance sheet, providing a cash runway into 2029, which does not account for potential Bidapertin revenues or PRV sales.
Nov 13, 2025, 1:40 PM
Disc Medicine Provides Updates on Bitopertin Approval, Pipeline, and Financials
IRON
Product Launch
New Projects/Investments
Guidance Update
- Disc Medicine's lead program, bitopertin, for erythropoietic protoporphyria (EPP), received a Commissioner's National Priority Voucher (CNPV), accelerating its projected approval to end of this year or early next year. The company plans to launch as soon as the FDA gives the green light, with a 24-person sales force targeting 6,000 engaged patients in the US.
- The company estimates bitopertin's peak sales potential to be between $800 million and $1.4 billion.
- Disc Medicine's 0974 program for anemia in myelofibrosis is currently in the RALI-MF trial, with an interim readout expected at ASH this year (in about a month from the document date). The trial aims for response rates of 30%, 50%, and 30% across different transfusion burden groups.
- The company reported approximately $826 million in pro forma cash on hand as of Q3 (after a recent stock offering), providing a financial runway into early 2029 without including bitopertin revenue.
Nov 10, 2025, 9:30 PM
Disc Medicine Reports Q3 2025 Financial Results and Bitopertin NDA Submission
IRON
Earnings
Product Launch
New Projects/Investments
- Disc Medicine, Inc. reported a net loss of $62.3 million for the third quarter ended September 30, 2025, compared to $26.6 million for the same period in 2024.
- The company maintained a strong financial position, ending Q3 2025 with approximately $615.9 million in cash, cash equivalents, and marketable securities. A public offering in October 2025 generated net proceeds of approximately $211 million, extending the cash runway into 2029.
- Disc Medicine submitted a New Drug Application (NDA) for accelerated approval of bitopertin in erythropoietic protoporphyria (EPP) on September 29, 2025, and received the FDA Commissioner\u2019s National Priority Voucher (CNPV), which is designed to shorten the NDA review period to 1-2 months from acceptance. Potential US approval and launch are anticipated in late 2025 or early 2026.
- The company is progressing its pipeline, with initial data from the Phase 2 study of DISC-0974 in anemia of myelofibrosis (MF) expected to be presented in December, and a Phase 1b study of DISC-3405 in sickle cell disease (SCD) initiated in October 2025.
Nov 6, 2025, 1:33 PM
Disc Medicine Prices Upsized Public Offering
IRON
New Projects/Investments
Guidance Update
- Disc Medicine, Inc. priced an upsized public offering of common stock and pre-funded warrants, expecting aggregate gross proceeds of approximately $225 million to the company and $25 million to the selling stockholder.
- The offering includes the sale of 2,619,049 shares of common stock and pre-funded warrants to purchase 59,523 shares of common stock by Disc Medicine, and 297,619 shares of common stock by AI DMI LLC, the selling stockholder, at an offering price of $84.00 per share for common stock.
- The selling stockholder also granted the underwriters a 30-day option to purchase up to an additional 446,428 shares, which was exercised in full on October 21, 2025.
- The net proceeds to Disc Medicine are expected to be approximately $210.9 million, which, combined with existing cash, is anticipated to fund operations into 2029.
- Proceeds from the offering will be used to support the potential commercialization of bitopertin, fund research and clinical development of product candidates, and for general corporate purposes.
Oct 22, 2025, 1:11 PM
Disc Medicine Submits Bitopertin NDA, Anticipates Accelerated Approval, and Reports Strong Q3 2025 Cash Position
IRON
Product Launch
New Projects/Investments
- Disc Medicine submitted a New Drug Application (NDA) for accelerated approval of bitopertin in erythropoietic protoporphyria (EPP) on September 29, 2025, and was awarded the FDA Commissioner’s National Priority Voucher (CNPV), which is designed to shorten the review period to 1-2 months. Potential US approval and launch are expected in late 2025 or early 2026.
- The company is advancing its hematology portfolio, with initial data from the Phase 2 RALLY-MF trial of DISC-0974 in anemia of myelofibrosis expected by year end, and initial data for DISC-3405 in polycythemia vera anticipated in 2026. Additionally, a Phase 2 study of DISC-0974 in anemia of inflammatory bowel disease is anticipated in Q1 2026, and a Phase 1b study of DISC-3405 in sickle cell disease is expected to initiate by year end.
- Disc Medicine reported a strong financial position, ending Q3 with approximately $615.9 million in cash, cash equivalents, and marketable securities as of September 30, 2025, which is projected to provide a cash runway into 2028.
Oct 20, 2025, 10:38 AM
Disc Medicine Provides Updates on Bidipertin Regulatory Pathway and DISC-974 Clinical Data
IRON
Product Launch
New Projects/Investments
- Disc Medicine's lead program, bidipertin, is scheduled for an NDA filing in October 2025 on an accelerated pathway, with anticipated NDA acceptance in December 2025. The company projects a launch around mid-2026.
- For bidipertin, the company has identified 14,000 diagnosed EPP patients in the Komodo claims database, with 6,000 considered engaged, and is using MSLs to confirm these numbers on the ground.
- The second program, DISC-nine seventy four, targeting anemia of myelofibrosis, is expected to present RALEY MF Phase two trial data at ASH. The company believes it is positioned as the only therapy on a path for this indication, which affects approximately 22,000 anemic patients in the US, following the failure of a competitor's (Bristol's luspatercept) Phase 3 trial.
- Disc Medicine also plans to present complete Phase one b SADMAD program data for its CKD anemia program before the end of 2025, either at ASN or ASH.
Sep 3, 2025, 4:04 PM
Quarterly earnings call transcripts for Disc Medicine.
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