Highest-materiality recent filing
Eton Q2 revenue $37.6M (+99% YoY), raises FY26 guidance to >$145M
Q2 net revenue $37.6M vs $18.9M YoY; GAAP EPS $0.35, non-GAAP $0.43.
Eton licenses late-stage ASN-001 (timolol gel) for infantile hemangiomas; $3M upfront
Upfront license fee $3M to Auson; milestones up to $33.5M based on sales thresholds; tiered royalties 10-15%.
Eton submits PAS to expand KHINDIVI indication to younger pediatric patients
Submitted Prior Approval Supplement to FDA to expand KHINDIVI label to include children under age 5.
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.
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)
Eton Pharmaceuticals launches HEMANGEOL Oral Solution for infantile hemangioma
HEMANGEOL is the only FDA-approved treatment for proliferating infantile hemangioma requiring systemic therapy.
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.
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.
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
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.
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.
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.
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.
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.
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.
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.
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.
Q1 2025 product sales $14.0M, 76% growth YoY; 17th straight quarter of sequential growth.
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.
FDA NDA submission for ET-600, a proprietary oral solution of desmopressin for central diabetes insipidus.
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.
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.
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.
Acquisition of Increlex from Ipsen closed Dec 19, 2024; must be accounted for as business combination.
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.
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.
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.
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.
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.
No upfront payment; up to $2.35M in milestone payments plus 14% royalty on net sales.
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.
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.
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.
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.
Eton Pharmaceuticals FDA accepts NDA for ET-400 (hydrocortisone oral solution); PDUFA Feb 28, 2025
PDUFA target action date set for February 28, 2025.
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.
Effective March 1, 2023, Eton Pharmaceuticals, Inc. (“Eton” or the “Company”) has appointed David Krempa to the position of Chief Business Officer.
Mr. Gruber succeeds Wilson Troutman, who retired as Chief Financial Officer, Corporate Secretary and Treasurer of the Company effective April 11, 2022 as well.
Effective April 11, 2022 the Board of Directors (the “Board”) of Eton Pharmaceuticals, Inc. (the “Company”) appointed James Gruber to serve as the Company’s Chief Financial Officer, Corporate Secretary and Treasurer.
Max materiality 0.85 · Median 0.65 · Most common event other_material