Eton Pharmaceuticals, INC 8-K filings

Eton Pharmaceuticals has acquired U.S. rights to ASN-001, a late-stage topical gel for infantile hemangiomas, aiming to complement its existing treatment and address a larger patient segment.

Eton Pharmaceuticals, Inc. announced the appointment of Danka Radosavljevic as Chief Operating Officer, effective July 31, 2026.

Eton Pharmaceuticals announced the submission of a Prior Approval Supplement to the FDA to expand the indication of KHINDIVI (hydrocortisone) oral solution to younger pediatric patients.

Eton Pharmaceuticals, Inc. held its 2026 Annual Meeting of Stockholders, where directors were elected and the appointment of its independent auditor was ratified.

Eton Pharmaceuticals has secured exclusive U.S. commercialization rights for IMPAVIDO (miltefosine), an FDA-approved oral therapy for leishmaniasis, expanding its rare disease portfolio.

Eton Pharmaceuticals announced the first patient dosed in a pilot study for ET-700, an extended-release zinc acetate formulation for Wilson disease, with topline results expected in late 2026.

Eton Pharmaceuticals has appointed Judith M. Matthews as the new Chief Financial Officer, effective June 1, 2026.

Eton Pharmaceuticals, Inc. has entered into a sixth amendment to its credit agreement with SWK Funding LLC, reducing interest rates and extending the interest-only period.

Eton Pharmaceuticals reported robust Q4 and full-year 2025 financial results, driven by new product launches and strong growth, projecting over $110 million in revenue for 2026.

Eton Pharmaceuticals has acquired the U.S. commercialization rights to HEMANGEOL, an FDA-approved treatment for infantile hemangioma, for $14 million upfront.

Eton Pharmaceuticals announced FDA approval for DESMODA (desmopressin acetate) Oral Solution, the first and only FDA-approved oral liquid formulation for central diabetes insipidus, with commercial launch expected March 9th.

Eton Pharmaceuticals secures U.S. marketing rights for an ultra-rare disease product candidate, aiming for a mid-2026 launch.

Eton Pharmaceuticals, Inc. announced its management will present at the Piper Sandler Annual Healthcare Conference on December 4, 2025.

Eton Pharmaceuticals files an amended 8-K to provide historical and pro forma financial statements for its recently completed acquisition of Increlex from Ipsen S.A.

Eton Pharmaceuticals reported robust third-quarter 2025 financial results, driven by 129% product sales growth and significant progress in its rare disease pipeline.

Eton Pharmaceuticals reported robust second-quarter 2025 financial results, achieving 108% product sales growth and reaching an $80 million annual revenue run rate a quarter ahead of schedule.

Eton Pharmaceuticals announced the FDA's acceptance of its New Drug Application for ET-600 (desmopressin oral solution), setting a target action date of February 25, 2026, and positioning the product for a potential Q1 2026 launch.

Eton Pharmaceuticals, Inc. announced its inclusion in the broad-market Russell 3000 and small-cap Russell 2000 Indexes, effective June 27, 2025, a move expected to enhance its visibility among institutional investors.

Eton Pharmaceuticals, Inc. announced the dismissal of Crowe LLP as its independent registered public accounting firm and the appointment of Grant Thornton LLP, effective June 13, 2025, with no reported disagreements or adverse opinions.

Eton Pharmaceuticals, Inc. announced the successful election of Paul V. Maier as a director for a three-year term and the ratification of Crowe LLP as its independent registered public accounting firm for 2025 at its virtual Annual Meeting held on June 10, 2025.

Eton Pharmaceuticals announced the U.S. FDA approval of KHINDIVI, its proprietary hydrocortisone oral solution, for pediatric adrenocortical insufficiency, with commercial launch expected the week of June 2nd and combined peak sales with ALKINDI SPRINKLE projected to exceed $50 million.

Eton Pharmaceuticals announced a 117% increase in net revenue for Q1 2025, driven by a 76% increase in product sales and strategic product launches.

Eton Pharmaceuticals withdraws its waiver request to the SEC and is preparing financial statements for the Increlex acquisition, now expected to be filed in the third quarter of 2025.

Eton Pharmaceuticals has submitted a New Drug Application (NDA) to the FDA for ET-600, an oral solution of desmopressin, targeting the treatment of central diabetes insipidus with a potential launch in Q1 2026.

Eton Pharmaceuticals has out-licensed the commercial rights to Increlex in territories outside the U.S. to Esteve Pharmaceuticals, focusing on U.S. growth opportunities.

Eton Pharmaceuticals held a virtual Investor Day presentation on March 18, 2025, where management discussed the company's strategy.

Eton Pharmaceuticals announced record product revenue of $11.6 million for Q4 2024, a 59% increase year-over-year, fueled by growth in ALKINDI SPRINKLE and Carglumic Acid, along with strategic acquisitions and pipeline advancements.

Eton Pharmaceuticals reports successful bioequivalence study results for ET-600, its patented desmopressin oral solution, paving the way for an NDA submission in April 2025.

Eton Pharmaceuticals reports non-compliance with SEC reporting obligations due to the inability to obtain required financial statements for the acquired Increlex product.

Eton Pharmaceuticals has commercially launched Galzin (zinc acetate) capsules, an FDA-approved treatment for Wilson disease, with a focus on improving patient access and affordability.