Recent 8-K filings for IRON
Highest-materiality recent filing
FDA issues Complete Response Letter for Disc Medicine's bitopertin NDA in erythropoietic protoporphyria
- FDA issued a Complete Response Letter on February 13, 2026 for bitopertin NDA for erythropoietic protoporphyria (EPP).
- The CRL indicates FDA will not approve the NDA in its current form, typically requiring additional data or analyses.
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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.
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Disc Medicine cuts 20% of workforce after FDA complete response letter for bitopertin
Restructuring plan approved Feb 26, 2026, reducing workforce by ~20%.
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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.
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FDA issued a Complete Response Letter on February 13, 2026 for bitopertin NDA for erythropoietic protoporphyria (EPP).
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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.
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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.
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Disc Medicine holds Dec 7 call to review ASH 2025 data and operational plans; exhibit incomplete
Conference call held on December 7, 2025 to review data from 67th ASH Annual Meeting.
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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.
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Net proceeds to Disc Medicine expected ~$210.9M; funds will support bitopertin commercialization for EPP/XLP, R&D, and general corporate purposes.
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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.
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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.
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Disc Medicine director Mona Ashiya resigns; board reduced to eight members
Mona Ashiya, Ph.D., resigned as Class I director effective October 3, 2025.
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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.
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Disc Medicine elects Nadim Ahmed as Class I director effective July 14, 2025
Nadim Ahmed elected to Board as Class I director, term until 2027 annual meeting.
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Disc Medicine stockholders elect three Class II directors, approve say-on-pay, ratify EY auditor
Elected Georges Gemayel, Mark Chin, and Liam Ratcliffe as Class II directors for three-year term ending 2028.
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Disc Medicine Q1 net loss $34.1M, cash $694.7M; bitopertin NDA on track H2 2025
Ended Q1 with $694.7M cash; expects to fund operations into 2028 after $259M January offering.
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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.
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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.
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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.
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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.
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Disc Medicine reviews ASH 2024 clinical data for bitopertin, DISC-0974, DISC-3405
Company held conference call on Dec 8 to review data presented at ASH Annual Meeting.
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Up to $200M of common stock may be sold at-the-market through Cantor Fitzgerald under a new Controlled Equity Offering agreement.
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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.
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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.
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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.
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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.
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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.
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Bitopertin reduced protoporphyrin IX by 40% in 60 mg group and cut phototoxic reactions by 75.3% (p=0.011) in AURORA trial.
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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.
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Disc Medicine stockholders elect Ashiya and Bitterman as Class I directors, ratify EY as auditor
Mona Ashiya, Ph.D. received 21,799,456 votes for and 149,253 withheld.
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Cash and cash equivalents $342.6M at March 31, 2024; provides runway well into 2026.
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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%.
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Cash and cash equivalents $360.4M at Dec 31, 2023, providing runway well into 2026.
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Disc Medicine appoints Pamela Stephenson as CCO; grants inducement equity award
Pamela Stephenson, MPH, named Chief Commercial Officer effective Feb 26, 2024.
Earnings & guidance
Materiality & sentiment trend
Max materiality 0.90 · Median 0.75 · Most common event other_material