Recent 8-K filings for ETON

• May 19, 2026, 4:45 PM ET M&A materiality 0.75 positive item 1.01item 2.01item 9.01

  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.

• May 14, 2026, 4:16 PM ET earnings materiality 0.80 positive item 2.02item 9.01

  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)

• May 1, 2026, 7:59 PM ET other material materiality 0.60 positive item 8.01item 9.01

  Eton Pharmaceuticals launches HEMANGEOL Oral Solution for infantile hemangioma

  HEMANGEOL is the only FDA-approved treatment for proliferating infantile hemangioma requiring systemic therapy.

• April 27, 2026, 7:59 PM ET other material materiality 0.65 positive item 8.01item 9.01

  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.

• April 16, 2026, 7:59 PM ET leadership materiality 0.65 neutral item 5.02item 7.01item 9.01

  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.

• March 19, 2026, 7:59 PM ET earnings materiality 0.80 positive item 2.02item 9.01

  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

• March 2, 2026, 6:59 PM ET M&A materiality 0.75 positive item 1.01item 2.01item 9.01 ◈ M&A Transactions◈ Material Agreements

  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.

• February 25, 2026, 6:59 PM ET regulatory materiality 0.85 positive item 8.01item 9.01

  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.

• February 2, 2026, 6:59 PM ET other material materiality 0.65 positive item 8.01item 9.01

  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.

• November 18, 2025, 6:59 PM ET M&A materiality 0.60 neutral item 2.01item 9.01item 8.01item 9.0 ◈ M&A Transactions

  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.

• November 6, 2025, 6:59 PM ET earnings materiality 0.75 positive item 2.02item 9.01

  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.

• August 7, 2025, 7:59 PM ET earnings materiality 0.75 positive item 2.02item 9.01

  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.

• July 8, 2025, 7:59 PM ET regulatory materiality 0.80 positive item 8.01item 9.01

  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.

• May 28, 2025, 7:59 PM ET regulatory materiality 0.80 positive item 8.01item 9.01

  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.

• May 13, 2025, 7:59 PM ET earnings materiality 0.80 positive item 2.02item 9.01

  Eton Q1 revenue $17.3M (+117% YoY); product sales $14.0M (+76%); Non-GAAP EPS $0.07; Adjusted EBITDA $3.7M

  Q1 2025 product sales $14.0M, 76% growth YoY; 17th straight quarter of sequential growth.

• May 2, 2025, 7:59 PM ET other material materiality 0.60 neutral item 2.01item 9.01item 8.01

  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.

• April 28, 2025, 7:59 PM ET regulatory materiality 0.65 positive item 8.01item 9.01

  Eton Pharmaceuticals submits NDA for ET-600 (desmopressin oral solution) for central diabetes insipidus

  FDA NDA submission for ET-600, a proprietary oral solution of desmopressin for central diabetes insipidus.

• April 1, 2025, 7:59 PM ET other material materiality 0.60 positive item 8.01item 9.01

  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.

• March 18, 2025, 7:59 PM ET earnings materiality 0.75 positive item 2.02item 9.01

  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.

• March 14, 2025, 7:59 PM ET other material materiality 0.72 positive item 8.01item 9.01

  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.

• March 7, 2025, 6:59 PM ET regulatory materiality 0.85 negative item 9.01item 2.01item 8.01

  Eton noncompliant with SEC reporting after Increlex acquisition; unable to provide audited financials

  Acquisition of Increlex from Ipsen closed Dec 19, 2024; must be accounted for as business combination.

• March 3, 2025, 6:59 PM ET other material materiality 0.65 positive item 8.01item 9.01

  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.

• January 3, 2025, 6:59 PM ET M&A materiality 0.75 positive item 2.01item 9.01

  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.

• December 20, 2024, 6:59 PM ET M&A materiality 0.85 positive item 2.01item 9.01

  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.

• December 17, 2024, 6:59 PM ET other material materiality 0.70 positive item 8.01item 9.01

  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.

• December 3, 2024, 6:59 PM ET leadership materiality 0.65 positive item 8.01item 9.01

  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.

• November 25, 2024, 6:59 PM ET M&A materiality 0.65 positive item 1.01item 9.01

  Eton Pharmaceuticals acquires U.S. rights to Amglidia (glyburide oral suspension) for neonatal diabetes

  No upfront payment; up to $2.35M in milestone payments plus 14% royalty on net sales.

• November 12, 2024, 6:59 PM ET earnings materiality 0.80 positive item 2.02

  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.

• November 7, 2024, 6:59 PM ET other material materiality 0.60 positive item 8.01item 9.01

  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.

• October 3, 2024, 7:59 PM ET M&A materiality 0.65 positive item 1.01item 9.01

  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.

• August 8, 2024, 7:59 PM ET earnings materiality 0.75 neutral item 2.02

  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.

• July 15, 2024, 7:59 PM ET regulatory materiality 0.70 positive item 8.01item 9.01

  Eton Pharmaceuticals FDA accepts NDA for ET-400 (hydrocortisone oral solution); PDUFA Feb 28, 2025

  PDUFA target action date set for February 28, 2025.

• May 9, 2024, 7:59 PM ET earnings materiality 0.70 positive item 2.02 ◈ Earnings Releases

  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.

• April 30, 2024, 7:59 PM ET regulatory materiality 0.70 positive item 8.01item 9.01

  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.

• March 22, 2024, 7:59 PM ET M&A materiality 0.65 positive item 8.01item 9.01

  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.

• March 14, 2024, 7:59 PM ET earnings materiality 0.75 neutral item 2.02item 9.01 ◈ Earnings Releases

  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

Materiality & sentiment trend

Max materiality 0.85 · Median 0.65 · Most common event other_material

33 positive 1 negative 15 neutral

source · ETON on sec.gov