Recent 8-K filings for ETON
Highest-materiality recent filing
Eton Pharmaceuticals receives FDA approval for DESMODA oral solution for central diabetes insipidus
- FDA approved DESMODA (desmopressin acetate) Oral Solution for central diabetes insipidus in all ages; first approved oral liquid formulation.
- Commercial launch expected March 9; product available exclusively through Anovo specialty pharmacy.
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Eton Pharmaceuticals secures U.S. commercialization rights to IMPAVIDO® for $4.25M fixed fees
Eton will pay $4.25M in fixed fees ($125k Jul 2026, then $1.25M Apr 2027, etc.) plus up to $4M in milestone payments based on cumulative net sales.
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Eton Pharma Q1 product sales $24.3M (+73% YoY); raises FY2026 guidance to >$120M
Q1 product sales $24.3M (+73% YoY); GAAP diluted EPS $0.05, non-GAAP diluted EPS $0.14, Adj. EBITDA $5.7M (24% margin)
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Eton Pharmaceuticals launches HEMANGEOL Oral Solution for infantile hemangioma
HEMANGEOL is the only FDA-approved treatment for proliferating infantile hemangioma requiring systemic therapy.
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Eton Pharmaceuticals initiates ET-700 pilot study for Wilson disease
First patient dosed in double-blinded, placebo-controlled trial comparing ET-700 to Galzin and placebo.
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Eton Pharmaceuticals appoints Judith Matthews as CFO effective June 1, 2026
Judith Matthews will become CFO on June 1, 2026, succeeding James Gruber who remains through May 31 then six-month consulting.
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Eton Pharmaceuticals amends credit facility: rate reduced, interest-only extended to Nov 2026
Interest rate reduced to SOFR plus 6.55% (from 6.75%); SOFR floor lowered from 5.0% to 2.75%.
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Eton Pharma Q4 product sales $21.3M (+83% YoY); guides FY26 rev >$110M, 30%+ EBITDA margin
Q4 product sales $21.3M (+83% YoY); GAAP diluted EPS $0.05, non-GAAP diluted EPS $0.19; Adj. EBITDA $6.2M
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Eton Pharma acquires U.S. rights to HEMANGEOL for $14M upfront
Eton pays $14M upfront plus 8% royalty; $1.5M inventory at close and $0.7M in May 2026.
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Eton Pharmaceuticals receives FDA approval for DESMODA oral solution for central diabetes insipidus
FDA approved DESMODA (desmopressin acetate) Oral Solution for central diabetes insipidus in all ages; first approved oral liquid formulation.
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Eton Pharmaceuticals licenses U.S. rights to ultra-rare disease candidate; FDA under review
Licensed product is first/only generic alternative for condition affecting <100 U.S. patients.
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Eton Pharmaceuticals presents at Piper Sandler conference; no new material facts disclosed
Management attending Piper Sandler Annual Healthcare Conference on December 4, 2025 in New York.
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Eton files historical financials for Increlex acquisition; product net sales $18.7M in 2023
Acquired Increlex for $22.5M upfront plus $7.5M inventory; $2.5M payments on 1st & 2nd anniversaries.
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Eton Q3 product sales $22.5M (+129% YoY), non-GAAP EPS $0.04, ET-600 PDUFA Feb 2026
Product sales of $22.5M, up 129% YoY; 19th consecutive quarter of sequential growth.
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Eton Q2 product sales $18.9M (+108% YoY); non-GAAP EPS $0.03; raises revenue run-rate guidance
Q2 product sales $18.9M, up 108% YoY; GAAP EPS $(0.10), non-GAAP EPS $0.03.
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Eton Pharma: FDA accepts NDA for ET-600 desmopressin oral solution; PDUFA Feb 25, 2026
FDA accepted NDA for ET-600 (desmopressin oral solution) with PDUFA target action date of February 25, 2026.
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Eton Pharmaceuticals added to Russell 2000 and Russell 3000 Indexes
Effective after market close June 27, 2025 as part of 2025 annual reconstitution.
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Eton Pharmaceuticals dismisses auditor Crowe, appoints Grant Thornton
Effective June 13, 2025, Eton dismissed Crowe LLP as its independent auditor.
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Eton stockholders elect director Paul V. Maier; ratify Crowe LLP as auditor
Paul V. Maier elected as director for three-year term with 11.67M votes for, 2.74M against.
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Eton Pharma gets FDA approval for KHINDIVI oral solution; peak sales >$50M
KHINDIVI is the first and only FDA-approved hydrocortisone oral solution for pediatric adrenocortical insufficiency.
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Q1 2025 product sales $14.0M, 76% growth YoY; 17th straight quarter of sequential growth.
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Eton withdraws SEC waiver request for Increlex financials; expects filing in Q3 2025
Company had requested a waiver from filing historical audited financials and pro forma statements for Increlex.
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FDA NDA submission for ET-600, a proprietary oral solution of desmopressin for central diabetes insipidus.
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Eton out-licenses international rights to Increlex to Esteve for €4M upfront
Esteve pays €4M upfront; license runs up to ten years with option to buy international rights for up to €6M.
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Eton Pharma Q4 2024 revenue $11.6M (+59% YoY); net loss narrows to $0.6M
Record product revenue of $11.6M in Q4 2024, up 59% from Q4 2023; 16th consecutive quarter of sequential growth.
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Eton Pharmaceuticals files 8-K with Investor Day presentation slides for March 18, 2025
Furnished as Exhibit 99.1 are slides for Eton's virtual Investor Day held March 18, 2025.
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ET-600 passes pivotal bioequivalence study; NDA submission expected April 2025
ET-600 (desmopressin oral solution) met primary endpoint in pivotal bioequivalence study of 75 healthy subjects.
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Acquisition of Increlex from Ipsen closed Dec 19, 2024; must be accounted for as business combination.
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Eton launches Galzin (zinc acetate) capsules for Wilson disease maintenance therapy
Galzin is FDA-approved for maintenance treatment of Wilson disease after chelator therapy; only FDA-approved zinc therapy for Wilson disease.
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Eton awarded patent for ET-600 desmopressin oral solution expiring 2044; NDA filing expected Q2 2025
USPTO granted U.S. Patent No. 12,214,010 covering ET-600's proprietary desmopressin oral solution formulation.
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FDA extends PDUFA date for Eton's ET-400 NDA to May 28, 2025
Original PDUFA date Feb 28, 2025 extended 3 months to May 28, 2025 for FDA review of supplemental info submitted Dec 2024.
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Eton acquires Galzin (zinc acetate) for $7.2M; rare disease product for Wilson Disease
Acquired Galzin from Teva Pharmaceuticals for $7.0M at closing plus $0.2M for inventory.
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Eton Pharma closes $22.5M Increlex acquisition; expands credit facility
Acquired Increlex (mecasermin) from Ipsen for $22.5M at closing plus $8.7M inventory; $2.5M due on first and second anniversaries.
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Eton Pharma announces PKU GOLIKE trial shows statistically significant metabolic control improvement
PKU GOLIKE showed statistically significant reduction in blood Phe (P=0.0002) and increase in Tyr (P=0.0113) vs standard substitutes during overnight fasting.
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Eton Pharmaceuticals raises $7.0M in registered direct offering of 583,334 shares at $12.00/share
Entered Securities Purchase Agreement on Dec 10, 2024 with an institutional investor.
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Eton Pharmaceuticals appoints Ipek Erdogan-Trinkaus as CCO; cites Increlex closing and ET-400 launch
Ipek Erdogan-Trinkaus appointed Chief Commercial Officer, effective December 3, 2024.
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No upfront payment; up to $2.35M in milestone payments plus 14% royalty on net sales.
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Eton Pharma Q3 product sales +40% YoY, first positive GAAP net income from product sales
Total revenue $10.3M, net income $0.6M ($0.02 diluted EPS); prior year net loss $0.6M.
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Eton Pharma awarded second patent for ET-400; PDUFA target Feb 28, 2025
USPTO granted U.S. Patent No. 12,133,914 for ET-400 (liquid hydrocortisone), expiring 2043.
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Eton Pharma to acquire Increlex from Ipsen for $22.5M upfront plus $7.5M inventory
Acquisition of Increlex (mecasermin injection) for severe primary IGF-1 deficiency; approved in 40 territories.
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Eton Q2 product sales up 40% YoY to $9.1M; ET-400 NDA accepted with Feb 2025 PDUFA
Product sales and royalty revenue $9.1M, up 40% YoY and 14% sequentially; 14th straight quarter of sequential growth.
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Eton board sets triennial say-on-pay votes despite shareholder annual preference
Board met Aug 1, 2024 and decided to hold say-on-pay votes every three years.
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Eton Pharmaceuticals FDA accepts NDA for ET-400 (hydrocortisone oral solution); PDUFA Feb 28, 2025
PDUFA target action date set for February 28, 2025.
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Eton replaces auditor KMJ Corbin with Crowe after KMJ partners join Crowe; no disagreements
KMJ Corbin resigned as independent auditor effective June 14, 2024; Crowe appointed same day with Audit Committee approval.
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Eton stockholders elect Riedel and Brynjelsen, approve exec comp and auditor
Norbert G. Riedel and Sean E. Brynjelsen re-elected as directors with 8,823,386 and 9,666,679 votes for, respectively.
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Eton Pharma Q1 revenue $8.0M (+50% YoY); acquires PKU GOLIKE; submits NDA for ET-400
Q1 2024 revenue $8.0M, up 50% YoY; net loss narrowed to $0.8M from $2.7M.
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Eton submits NDA to FDA for ET-400 hydrocortisone oral solution; approval expected Q1 2025
NDA submitted for ET-400, a proprietary patented hydrocortisone oral solution.
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Eton cancels $13.1M equity raise and credit expansion after losing Eiger auction
Planned to issue 1,287,500 common shares at $3.50 and pre-funded warrants for 2,462,500 shares.
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Eton Pharma acquires U.S. rights to PKU GOLIKE for $2.2M upfront plus milestones and 30% royalty
Acquired U.S. rights to PKU GOLIKE for $2.2M upfront, up to $2M milestones, and 30% royalty on net sales.
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Eton Pharma Q4 revenue up 109% to $7.3M; ET-400 NDA submission planned Q2 2024
Q4 2023 product sales & royalty revenue $7.3M, up 109% YoY; full-year revenue $26.1M (+132%).
Earnings & guidance
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