Highest-materiality recent filing
Disc Medicine aligns with FDA on bitopertin CRL path; APOLLO topline due Q4 2026
FDA Type A meeting aligned that successful Phase 3 APOLLO can serve as basis for CRL response; topline data expected Q4 2026.
Disc Medicine Q1 net loss widens to $63.5M; bitopertin Phase 3 enrollment complete
Net loss $63.5M vs $34.1M YoY; R&D expenses rose to $45.9M, SG&A to $23.6M.
Disc Medicine cuts 20% of workforce after FDA complete response letter for bitopertin
Restructuring plan approved Feb 26, 2026, reducing workforce by ~20%.
Disc Medicine reports FY2025 net loss $212.2M; receives CRL for bitopertin; cash runway into 2029
Net loss of $212.2M for FY2025, up from $109.4M in FY2024; driven by higher R&D and SG&A costs.
FDA issued a Complete Response Letter on February 13, 2026 for bitopertin NDA for erythropoietic protoporphyria (EPP).
FDA issues Complete Response Letter for Disc Medicine's bitopertin NDA for EPP; approval delayed
FDA acknowledged bitopertin significantly lowers PPIX but found insufficient evidence that PPIX change predicts clinical benefit.
Disc Medicine reports $791M cash; bitopertin NDA under priority review with CNPV
Preliminary unaudited cash, equivalents and securities ~$791M as of Dec 31, 2025; runway into 2029.
Disc Medicine reports Q3 net loss of $62.3M; files NDA for bitopertin in EPP with priority review
Submitted NDA for bitopertin in EPP seeking accelerated approval; FDA CNPV shortens review to 1-2 months; potential US launch late 2025/early 2026.
Net proceeds to Disc Medicine expected ~$210.9M; funds will support bitopertin commercialization for EPP/XLP, R&D, and general corporate purposes.
Disc Medicine reports $615.9M cash; bitopertin NDA submitted for accelerated review (CNPV)
Preliminary unaudited cash, equivalents and marketable securities of ~$615.9M as of September 30, 2025.
Disc Medicine receives FDA priority voucher for bitopertin in EPP; review time cut to 1-2 months
FDA granted CNPV for bitopertin in erythropoietic protoporphyria (EPP) including X-linked protoporphyria.
Disc Medicine Q2 net loss $55.2M; on track for bitopertin NDA in October 2025
Cash of $650.0M as of June 30, 2025; expected to fund operations into 2028.
Disc Medicine: 2024 net loss $109.4M, bitopertin NDA on track H2 2025 via accelerated approval
Full-year 2024 net loss $109.4M vs $76.4M in 2023; R&D expenses rose to $96.7M.
Disc Medicine prices $225.5M upsized public offering of common stock and pre-funded warrants
Offering of 3,918,182 shares at $55.00/share and 181,818 pre-funded warrants at $54.9999 each.
Disc Medicine aligns with FDA on bitopertin confirmatory trial design; NDA planned H2 2025
Achieved FDA alignment on APOLLO post-marketing trial design for bitopertin in EPP and XLP.
Disc Medicine discloses ITGC material weakness; outlines bitopertin NDA plan and 2025 milestones
Material weakness in ITGC over key financial IT systems; no misstatements identified to date.
Up to $200M of common stock may be sold at-the-market through Cantor Fitzgerald under a new Controlled Equity Offering agreement.
Disc Medicine Reports Third Quarter 2024 Financial Results and Provides Business Update
Completed successful end-of-Phase 2 meeting with FDA for bitopertin in EPP, reaching alignment on all proposed study parameters with potential for accelerated approval.
Disc Medicine secures up to $200M non-dilutive debt facility from Hercules Capital
$200M senior secured term loan facility from Hercules Capital; $30M drawn at closing.
FDA agreed on all APOLLO trial parameters: single placebo-controlled study, 60 mg dose, 6-month duration, primary endpoint of monthly sunlight time without pain.
Disc Medicine presents positive Phase 1b data for DISC-0974 in CKD anemia at ASN Kidney Week
Dose-dependent hepcidin reduction >75% from baseline at highest dose (60 mg); transferrin saturation up to 3x baseline.
Disc Medicine Q2 net loss $26.4M; cash $500.9M; positive EHA data across pipeline
Net loss of $26.4M for Q2 2024 vs $15.9M in Q2 2023; R&D expenses rose to $23.5M.
Bitopertin reduced protoporphyrin IX by 40% in 60 mg group and cut phototoxic reactions by 75.3% (p=0.011) in AURORA trial.
Disc Medicine prices $178M underwritten offering of 4.94M shares at $36.00
Priced 4,944,000 shares at $36.00; gross proceeds ~$178M, net ~$172.3M.
Cash and cash equivalents $342.6M at March 31, 2024; provides runway well into 2026.
Disc Medicine bitopertin Phase 2 in EPP meets primary endpoint; key secondary misses significance
Primary endpoint met: PPIX reduced 21.6% (20mg, p=0.003) and 40.7% (60mg, p<0.001) vs placebo +8.0%.
Cash and cash equivalents $360.4M at Dec 31, 2023, providing runway well into 2026.
PPIX levels reduced >40% (p<0.001) from baseline; sustained and dose-dependent in 22 EPP patients.
DISC-0974 reduced serum hepcidin >75% and increased serum iron >75% at 28 mg dose.
Disc Medicine amends ATM agreement to increase potential offering from $59.7M to $200.0M
As of Dec 5, 2023, only $7.2M of Initial $59.7M shares had been sold under original Oct 2023 ATM.
Disc Medicine Q3 net loss $14.1M; bitopertin Phase 2 enrollment complete
Cash $370.5M as of Sep 30, 2023; expected to fund operations into 2026.
Enrollment complete for Phase 2 BEACON (n=22 adults) and AURORA (n=75 adults) bitopertin trials in EPP; BEACON expanded to adolescents.
Disc Medicine enters ATM equity offering agreement for up to $59.7M with Jefferies
Entered Open Market Sale Agreement with Jefferies to sell up to $59.7M of common stock at-the-market.
Disc Medicine Q2 net loss $15.9M, cash $378M; BEACON bitopertin data positive
Net loss $15.9M in Q2 2023 vs $9.6M in Q2 2022; R&D expense $12.1M, G&A $5.2M.
Disc Medicine prices upsized $137.2M public offering of common stock and pre-funded warrants
Priced 2,595,919 shares at $49.00 per share and 204,081 pre-funded warrants at $48.9999 each.
Mean reduction of whole-blood PPIX >40% in dose-dependent, sustained manner across 15 patients.
On February 7, 2024 (the "Promotion Date"), the Company announced that Jonathan Yu, the Company's previous Chief Business Officer, was promoted to serve as the Company's Chief Operating Officer.
On February 7, 2024, the Company announced the appointment of Jean M. Franchi as Chief Financial Officer and Treasurer, effective February 7, 2024
Ms. Franchi succeeds Joanne Bryce, who, as previously announced by the Company, will depart from her role as Chief Financial Officer and Treasurer, effective as of the Effective Date.
On October 23, 2023, Disc Medicine, Inc. (the “Company”) announced that Joanne Bryce plans to depart from her position as Chief Financial Officer effective upon the Company identifying her successor.
On April 18, 2023, Jay T. Backstrom, M.D., M.P.H., a member of the Board of Directors (the “Board) of Disc Medicine, Inc. (the “Company”), notified the Company of his resignation from the Board effective as of the close of business on June 9, 2023.
Georges Gemayel, Mark Chin and Liam Ratcliff appointed as Class II directors
Donald Nicholson, William White and John Quisel appointed as Class III directors
Donald Nicholson, Ph.D. was appointed as the executive chairman of the board.
Mona Ashiya, Kevin Bitterman and Jay Backstrom appointed as Class I directors
Carl Gordon, Ph.D., CFA, David Lubner, Tuyen Ong, M.D., MRCOphth., Jason Rhodes and Jim Tananbaum, M.D. resigned from the Company’s board of directors and committees of the board of directors on which they respectively served, which resignations were not the result of any disagreements with the Company relating to the Company’s operations, policies or practices.
Mona Ashiya, Kevin Bitterman and Jay Backstrom appointed as Class I directors
Donald Nicholson, William White and John Quisel appointed as Class III directors
Max materiality 0.90 · Median 0.70 · Most common event other_material