Eton Pharmaceuticals, Inc.

Eton Pharmaceuticals, Inc. has launched a new development program, ET-900, to evaluate mecasermin injection for the treatment of infantile and epileptic spasms. The company has secured a license from Baylor College of Medicine for patent rights related to insulin-like growth factor 1 (IGF-1) for spasm treatment. An Investigational New Drug (IND) application has been submitted to the FDA for an investigator-sponsored Phase 2 clinical study, with initial patient dosing anticipated in the first quarter of 2027. Preclinical data suggests IGF-1 therapy can reduce spasms.

Eton Pharmaceuticals reported strong financial results for Q2 2026, with net revenues nearly doubling to $37.59 million and a significant turnaround to a net income of $11.58 million, or $0.35 diluted EPS, compared to a net loss in the prior year. For the first six months of 2026, net revenues increased by 70.8% to $61.86 million, resulting in a net income of $13.13 million. The company also saw an increase in total assets to $115.81 million, driven partly by investments in product license rights.

Eton Pharmaceuticals, Inc. reported strong financial results for the second quarter ended June 30, 2026, with product sales surging 99% year-over-year to $37.6 million. The company achieved a GAAP fully diluted EPS of $0.35 and an Adjusted EBITDA of $16.2 million. Following this performance, Eton raised its full-year 2026 revenue guidance to over $145 million and its Adjusted EBITDA margin guidance to at least 35%. Key business highlights included the successful relaunch of HEMANGEOL®, the acquisition of product candidate ASN-001 and orphan drug IMPAVIDO®, and progress in its development pipeline with FDA Fast Track designation for AMGLIDIA®.

Eton Pharmaceuticals, Inc. has entered into a license agreement with Auson Pharmaceuticals Inc. for the U.S. rights to ASN-001 (timolol topical gel), a late-stage rare disease product candidate for proliferating superficial infantile hemangiomas. Eton will pay an upfront fee of $3.0 million, with potential milestone payments up to $33.5 million based on FDA approval and sales targets, plus tiered royalties. The company plans to submit a New Drug Application (NDA) in the second half of 2027, aiming to address a patient population estimated at 20,000 to 30,000 annually and complement its existing HEMANGEOL product.

Eton Pharmaceuticals announced it has licensed U.S. rights to ASN-001 (timolol topical gel) from Auson Pharmaceuticals, a late-stage product candidate for proliferating superficial infantile hemangiomas. This acquisition positions Eton to address the full spectrum of infantile hemangioma treatment, complementing its existing product HEMANGEOL. The company plans to submit a New Drug Application (NDA) in the second half of 2027, with potential approval and launch in 2028, targeting an estimated 20,000 to 30,000 patients annually.

Eton Pharmaceuticals, Inc. announced the appointment of Danka Radosavljevic as its new Chief Operating Officer, effective July 31, 2026. Ms. Radosavljevic, who joined the company in 2017, previously held the position of Executive Vice President, Operations for over five years, overseeing critical functions including quality, product development, regulatory, supply chain, and information systems. Her compensation package includes an annual base salary of $520,800 and a target annual discretionary incentive bonus of 50% of her base salary.

Eton Pharmaceuticals, Inc. announced it will report its second quarter 2026 financial results on Thursday, August 13, 2026. Following the release, management will host a conference call and live audio webcast at 4:30 p.m. ET to discuss the results. Investors will have the opportunity to submit questions via email prior to the call.

Eton Pharmaceuticals announced the submission of a Prior Approval Supplement (PAS) to the U.S. Food and Drug Administration (FDA) for KHINDIVI® (hydrocortisone) oral solution. This submission seeks to expand the product's label to include younger pediatric patients, as the new formulation successfully demonstrated bioequivalence to ALKINDI SPRINKLE®. The company anticipates a potential approval for the expanded indication in the first half of 2027, aiming to address the largest need for an FDA-approved oral liquid hydrocortisone in children under five.

Eton Pharmaceuticals announced the submission of a Prior Approval Supplement (PAS) to the U.S. FDA for KHINDIVI (hydrocortisone) oral solution. The submission aims to expand the product's label to include younger pediatric patients, specifically those under five years of age, for adrenocortical insufficiency. A new formulation of KHINDIVI successfully demonstrated bioequivalence to ALKINDI SPRINKLE®, and the company anticipates potential FDA approval for this expanded indication in the first half of 2027.

Eton Pharmaceuticals, Inc. announced it has entered into a supply and distribution agreement for the exclusive U.S. commercialization rights to IMPAVIDO® (miltefosine) from an affiliate of Knight Therapeutics, Inc. IMPAVIDO® is the first and only FDA-approved oral therapy for visceral, cutaneous, and mucosal leishmaniasis, a rare and potentially life-threatening parasitic disease. The agreement, which takes effect on September 26, 2026, expands Eton's growing portfolio of orphan therapies and reinforces its focus on rare disease commercialization.