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Disc Medicine Reports Third Quarter 2025 Financial Results and Provides Business Update

Key Takeaway: Disc Medicine, Inc. reported its third quarter 2025 financial results, highlighting significant progress in its drug development pipeline. The company successfully submitted a New Drug Application for bitopertin and received a Critical New Product Validation. With a solid financial foundation, Disc anticipates further advancements in its clinical trials and preparations for potential product launches.
Price reaction · baseline $88.31 (2025-11-05 close) · hit pre-market · clean, no other IRON news in the window
day 0 close · peak
-1.5%

Market Sentiment Analysis

POSITIVE FACTORS

  • Successful NDA submission for bitopertin in EPP.
  • Strong financial position with cash runway into 2029.
  • Progress across the entire pipeline with upcoming data releases.

CONCERNS & RISKS

  • Risks associated with the FDA review process.
  • Potential delays in clinical trial timelines.

BiopharmaWatch Analysis

From our catalyst data and publicly available data · not financial advice
Best trade, last catalyst
+45%
120-day peak, hindsight
Typical move
3.9%
average across 7 past catalysts
Cash runway
~48 mo
Minimal dilution risk
Lead asset
DISC-0974
Phase 2 · Inflammatory Bowel Disease (IBD)

Full Press Release Details

WATERTOWN, Mass., Nov. 06, 2025 (GLOBE NEWSWIRE) -- Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from serious hematologic diseases, today reported financial results for the third quarter ended September 30, 2025, and provided a review of recent program and corporate developments.
“We are incredibly proud of the progress across our entire pipeline this quarter, most notably around our NDA submission for bitopertin in EPP at the end of September and subsequent receipt of the CNPV,” said John Quisel, J.D., Ph.D., Chief Executive Officer and President of Disc. “Achieving this milestone is a strong testament to our team’s commitment to execution and dedication to bringing a potential new treatment option to the EPP patient community. We continue to work with the Agency on their review of our application, and we are furthering our commercial infrastructure in preparation for a potential launch.”
“Beyond bitopertin, our broader pipeline is progressing well, as we expect new data from the Phase 2 trial of DISC-0974 in MF anemia by the end of the year and data from studies of DISC-3405 in PV and SCD next year. With a strong balance sheet providing cash runway into 2029, we are well-positioned to prepare for the anticipated launch of bitopertin and ultimately advancing towards our goal of delivering new treatment options to patients suffering from hematological diseases.”

Recent Highlights and Anticipated Milestones:

Bitopertin: GlyT1 Inhibitor (Heme Synthesis Modulator)

DISC-0974: Anti-Hemojuvelin Antibody (Hepcidin Suppression)

DISC-3405: Anti-TMPRSS6 Antibody (Hepcidin Induction)

Third Quarter 2025 Financial Results:

About Disc Medicine

Disc Medicine (NASDAQ:IRON) is a clinical-stage biopharmaceutical company committed to discovering, developing, and commercializing novel treatments for patients who suffer from serious hematologic diseases. We are building a portfolio of innovative, potentially first-in-class therapeutic candidates that aim to address a wide spectrum of hematologic diseases by targeting fundamental biological pathways of red blood cell biology, specifically heme biosynthesis and iron homeostasis. For more information, please visitwww.discmedicine.com.

Available Information

Disc announces material information to the public about the Company, its products and services, and other matters through a variety of means, including filings with the U.S. Securities and Exchange Commission (SEC), press releases, public conference calls, webcasts and the investor relations section of the Company website at ir.discmedicine.com in order to achieve broad, non-exclusionary distribution of information to the public and for complying with its disclosure obligations under Regulation FD.

Disc Cautionary Statement Regarding Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, express or implied statements regarding: Disc's expectations with respect to the next stages of its development programs for bitopertin, DISC-0974 and DISC-3405, including projected timelines for the initiation and completion of its clinical trials, anticipated timing of release of data, and other clinical activities; the registrational pathway for bitopertin, including the potential for accelerated approval, benefits of the CNPV, expected review period and the timing of approval, if granted; anticipated discussions with regulatory agencies; ongoing preparations for the potential launch of bitopertin; and the strength of its financial position and its anticipated cash runway. The use of words such as, but not limited to, “believe,” “expect,” “estimate,” “project,” “intend,” “future,” “potential,” “continue,” “may,” “might,” “plan,” “will,” “should,” “seek,” “anticipate,” or “could” or the negative of these terms and other similar words or expressions that are intended to identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on Disc’s current beliefs, expectations and assumptions regarding the future of Disc’s business, future plans and strategies, clinical results and other future conditions. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.
Disc may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and investors should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements as a result of a number of material risks and uncertainties including but not limited to: the adequacy of Disc’s capital to support its future operations and its ability to successfully initiate and complete clinical trials; the nature, strategy and focus of Disc; the difficulty in predicting the time and cost of development of Disc’s product candidates; Disc’s plans to research, develop and commercialize its current and future product candidates; the timing of initiation of Disc’s planned preclinical studies and clinical trials; the timing of the availability of data from Disc’s clinical trials; Disc’s ability to identify additional product candidates with significant commercial potential and to expand its pipeline in hematological diseases; the timing and anticipated results of Disc’s preclinical studies and clinical trials and the risk that the results of Disc’s preclinical studies and clinical trials may not be predictive of future results in connection with future studies or clinical trials and may not support further development and marketing approval; the content and timing of decisions made by the FDA and other regulatory authorities; and the other risks and uncertainties described in Disc’s filings with the Securities and Exchange Commission, including in the “Risk Factors” section of Disc’s Annual Report on Form 10-K for the year ended December 31, 2024, and in subsequent Quarterly Reports on Form 10-Q. Any forward-looking statement speaks only as of the date on which it was made. None of Disc, nor its affiliates, advisors or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as result of new information, future events or otherwise, except as required by law.
DISC MEDICINE, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except share and per share amounts)
(Unaudited)
Three months ended September 30, Nine months ended September 30,
2025 2024 2025 2024
Operating expenses:
Research and development $ 50,334 $ 24,685 $ 124,416 $ 71,874
Selling, general and administrative 17,362 8,171 44,636 23,296
Total operating expenses 67,696 32,856 169,052 95,170
Loss from operations (67,696 ) (32,856 ) (169,052 ) (95,170 )
Other income (expense), net 5,477 6,371 17,672 15,449
Income tax expense (102 ) (114 ) (273 ) (179 )
Net loss $ (62,321 ) $ (26,599 ) $ (151,653 ) $ (79,900 )
Net loss per share, basic and diluted $ (1.77 ) $ (0.89 ) $ (4.39 ) $ (2.98 )
Weighted-average common shares outstanding, basic and diluted 35,178,691 29,935,551 34,516,134 26,809,605
DISC MEDICINE, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands)
September 30, December 31,
2025 2024
(Unaudited)
Assets
Cash, cash equivalents, and marketable securities $ 615,920 $ 489,881
Other current assets 11,248 3,734
Total current assets 627,168 493,615
Non-current assets 3,288 3,158
Total assets $ 630,456 $ 496,773
Liabilities and Stockholders’ Equity
Current liabilities $ 26,744 $ 23,316
Non-current liabilities 30,321 29,870
Total liabilities 57,065 53,186
Total stockholders’ equity 573,391 443,587
Total liabilities and stockholders’ equity $ 630,456 $ 496,773

Media ContactPeg RusconiDeerfield Grouppeg.rusconi@deerfieldgroup.com

Investor Relations ContactChristina TartagliaPrecision AQchristina.tartaglia@precisionaq.com

Frequently Asked Questions

What were the key highlights from Disc Medicine's Q3 2025 report?

Disc Medicine highlighted the NDA submission for bitopertin and strong pipeline progress.

What is the financial outlook for Disc Medicine?

Disc Medicine has a solid financial position with a cash runway extending into 2029.

What upcoming data can we expect from Disc Medicine?

New data from the Phase 2 trial of DISC-0974 is expected by the end of the year.

What is bitopertin used for?

Bitopertin is a treatment for patients suffering from erythropoietic protoporphyria (EPP).

Last updated: Nov 6, 2025