Welcome to our dedicated page for Eton Pharmaceuticals news (Ticker: ETON), a resource for investors and traders seeking the latest updates and insights on Eton Pharmaceuticals stock.
Eton Pharmaceuticals develops and commercializes treatments for rare diseases, with commercial products that include KHINDIVI, INCRELEX, ALKINDI SPRINKLE, DESMODA, GALZIN, HEMANGEOL, PKU GOLIKE, Carglumic Acid, Betaine Anhydrous and Nitisinone. Company news commonly covers FDA approvals, product launches, licensing of U.S. commercialization rights, specialty pharmacy distribution and Eton Cares patient-support programs.
Updates also address financial results, product-sales trends, late-stage product candidates and clinical work for rare-disease therapies. Pipeline references include Amglidia, ET-700, ET-800 and ZENEO hydrocortisone autoinjector, with ET-700 described as an extended-release zinc acetate formulation for Wilson disease.
Eton Pharmaceuticals (Nasdaq: ETON) has licensed U.S. rights to rare disease product candidate ASN-001 (timolol topical gel) from Auson Pharmaceuticals for proliferating superficial infantile hemangiomas. Auson completed a 168-patient Phase II/III trial where week‑24 elimination or near‑elimination rates were 56% (twice daily) and 42% (three times daily) versus 15% for placebo.
Eton plans a bioavailability bridging study and anticipates a New Drug Application (NDA) in 2H 2027, with potential U.S. approval and launch in 2028. According to Eton, an FDA‑approved topical option could serve an estimated 20,000–30,000 patients annually, compared with 10,000–15,000 systemic HEMANGEOL patients, and may become its largest revenue contributor. ASN‑001, which complements HEMANGEOL and would target a moderate patient population currently treated off‑label with ophthalmic timolol, has patent protection through 2044.
Eton Pharmaceuticals (Nasdaq: ETON) announced it will report its second quarter 2026 financial results on Thursday, August 13, 2026. Management will host a conference call and live audio webcast at 4:30 p.m. ET (3:30 p.m. CT) to discuss the results and take investor questions.
Investors may submit questions by email to investorrelations@etonpharma.com. The live webcast and a 30-day archive will be available in the Investors section of Eton’s website at https://ir.etonpharma.com/.
Eton Pharmaceuticals (Nasdaq: ETON) reported that a new formulation of KHINDIVI (hydrocortisone) oral solution demonstrated bioequivalence to ALKINDI SPRINKLE, the FDA‑approved hydrocortisone granule formulation. Based on these data, Eton has submitted a Prior Approval Supplement (PAS) to the U.S. FDA seeking to expand KHINDIVI’s label to include younger pediatric adrenal insufficiency patients, below the current approval for ages five years and older.
According to Eton, the PAS could support a potential expanded indication decision in the first half of 2027. KHINDIVI is currently the only FDA‑approved oral hydrocortisone solution and carries extensive safety warnings, including risks of adrenal crisis, systemic adverse reactions from inactive ingredients, growth retardation, Cushing’s syndrome, decreased bone mineral density, psychiatric, ophthalmic, and gastrointestinal adverse reactions.
Eton Pharmaceuticals (Nasdaq:ETON) signed a supply and distribution agreement for exclusive U.S. commercialization rights to IMPAVIDO (miltefosine), effective September 26, 2026. IMPAVIDO is the first and only FDA-approved oral therapy for visceral, cutaneous, and mucosal leishmaniasis caused by specific Leishmania species in eligible patients.
The deal expands Eton’s rare disease portfolio and supports its orphan-focused commercial model.
Eton Pharmaceuticals (Nasdaq: ETON) reported Q1 2026 net revenue and product sales of $24.3 million, with product sales up 73% year-over-year. GAAP diluted EPS was $0.05, non-GAAP EPS $0.14, and Adjusted EBITDA $5.7 million (24% margin).
The company raised 2026 revenue guidance to more than $120 million and targets at least a 30% Adjusted EBITDA margin. Eton launched FDA-approved DESMODA, acquired and relaunched HEMANGEOL, initiated the ET-700 trial, advanced KHINDIVI label expansion, and received FDA clearance for an INCRELEX label harmonization study.
Eton Pharmaceuticals (Nasdaq: ETON), a rare disease-focused pharmaceutical company, announced executive participation in three investor conferences in May and June 2026.
Events include the B. Riley Securities and Craig-Hallum conferences without presentations, and a Jefferies Global Healthcare Conference appearance with a webcast on June 4, 2026.
Eton Pharmaceuticals (NASDAQ: ETON) will report first quarter 2026 financial results on Thursday, May 14, 2026, and will host a conference call and live audio webcast at 4:30 p.m. ET (3:30 p.m. CT).
Management will take live questions on the call and answer emailed investor questions sent to investorrelations@etonpharma.com. The live webcast is available on the company's Investors website, with an archived webcast posted about two hours after the event and available for 30 days.
Eton Pharmaceuticals (Nasdaq: ETON) announced the relaunch of HEMANGEOL (propranolol) oral solution on May 1, 2026, now distributed exclusively through Anovo Specialty Pharmacy with integrated Eton Cares patient support.
Key elements: $0 co-pay for eligible commercially insured patients, expanded patient assistance, orphan drug indication for proliferating infantile hemangioma, treatment window typically five weeks to five months, and an estimated 5,000–10,000 infants treated annually in the U.S.
Eton Pharmaceuticals (Nasdaq: ETON) announced first patient dosing in a pilot clinical study of ET-700, an extended-release zinc acetate formulation for Wilson disease. The double-blind, placebo-controlled PET imaging study (n=36) compares GALZIN 50 mg TID, ET-700 75 mg BID plus placebo, and placebo TID.
Topline results are expected in the second half of 2026; a pivotal study could start in early 2027 if results are positive. The primary endpoint is change in hepatic 64Cu uptake by PET.
Eton Pharmaceuticals (Nasdaq: ETON) announced Judith M. Matthews will become Chief Financial Officer effective June 1, 2026. Matthews brings more than 25 years of finance leadership in pharma and biotech. Current CFO James Gruber will remain through May 31, 2026 and then enter a six-month consulting agreement.