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, Inc. (NASDAQ: ETON) is a pharmaceutical company focused on developing and commercializing treatments for rare diseases, with particular emphasis on pediatric endocrinology and other rare endocrine and metabolic disorders. Its 2025 press releases highlight a growing portfolio of eight commercial rare disease products, including KHINDIVI, INCRELEX, ALKINDI SPRINKLE, GALZIN, PKU GOLIKE, Carglumic Acid, Betaine Anhydrous, and Nitisinone, along with late-stage candidates such as ET-600, Amglidia, ET-700, ET-800, and the ZENEO hydrocortisone autoinjector.
The ETON news feed features updates on FDA regulatory milestones, product launches, financial results, and corporate developments. Examples include the U.S. FDA approval of KHINDIVI (hydrocortisone) Oral Solution for pediatric adrenocortical insufficiency, the FDA’s acceptance of the New Drug Application for ET-600 (desmopressin oral solution) with a specified PDUFA target action date, and quarterly earnings reports detailing product sales growth and pipeline investment. The company also reports on its acquisition and relaunch of INCRELEX and GALZIN, and on its inclusion in the Russell 2000 and Russell 3000 indexes.
Investors following ETON news can track how Eton’s commercial portfolio and pipeline evolve through regulatory decisions, label expansion efforts, clinical study plans, and conference participation. Regular press releases also discuss non-GAAP metrics such as Adjusted EBITDA, providing additional context for financial performance. This news page aggregates these company-issued updates so readers can review Eton’s rare disease strategy, key product milestones, and ongoing engagement with the healthcare and investment communities.
Eton Pharmaceuticals (Nasdaq: ETON) announced U.S. FDA approval of DESMODA (desmopressin acetate) oral solution for central diabetes insipidus in adults and pediatric patients.
Key points: first FDA-approved desmopressin oral liquid; commercial launch March 9, 2026; ready-to-use 0.05 mg/mL formulation; estimated >13,000 U.S. patients; expected peak sales $30–50 million annually; patent protection through 2044. DESMODA will be distributed exclusively via Anovo with patient support through the Eton Cares program.
Eton Pharmaceuticals (Nasdaq: ETON) announced its executive leadership will hold one-on-one meetings at the Leerink Partners Global Healthcare Conference on Wednesday, March 11, 2026 in Miami, Florida. Investors and institutional representatives can schedule 1x1 meetings through their Leerink Partners institutional sales representative.
Eton Pharmaceuticals (Nasdaq: ETON) licensed U.S. marketing rights to an ultra-rare disease product candidate currently under FDA review, targeting approval and launch in mid-2026.
The product would be the first generic alternative for an ultra-rare condition affecting fewer than 100 patients in the U.S., and the company says the asset complements its commercial infrastructure and patient-support programs.
Eton Pharmaceuticals (Nasdaq: ETON) will present a fireside chat at the Piper Sandler 37th Annual Healthcare Conference in New York City on Thursday, December 4, 2025 at 9:30 AM ET.
Members of the company's executive leadership team will host the session at the Lotte New York Palace. Investors seeking a one-on-one meeting should contact their Piper Sandler institutional sales representative to schedule engagements.
Eton Pharmaceuticals (Nasdaq: ETON) said members of its executive leadership will host 1x1 meetings at the 16th Annual Craig-Hallum Alpha Select Conference on November 18, 2025 in New York, NY.
Investors or institutional representatives seeking a meeting are instructed to contact their Craig-Hallum institutional sales representative to schedule a 1x1.
Eton Pharmaceuticals (Nasdaq: ETON) reported Q3 2025 product sales of $22.5 million, a 129% year-over-year increase and the 19th consecutive quarter of sequential product sales growth. GAAP EPS was $(0.07), non-GAAP EPS was $0.04, and Adjusted EBITDA was $2.9 million. The company had $37.1 million in cash and generated $12.0 million of operating cash flow in the quarter.
Pipeline and commercial updates include an NDA for ET-600 accepted with a PDUFA date of February 25, 2026, GALZIN relaunch ahead of plan, progress toward KHINDIVI label expansion with a planned bioequivalence study, and an ET-700 pilot PET study scheduled to begin in Q1 2026.
Eton Pharmaceuticals (Nasdaq: ETON) announced it will report third quarter 2025 financial results on Thursday, November 6, 2025. Management will host a conference call and live audio webcast at 4:30 p.m. ET (3:30 p.m. CT) to discuss results and take live and emailed investor questions.
Investors may submit questions to investorrelations@etonpharma.com. The live webcast is available on the company investor website at https://ir.etonpharma.com/. An archived webcast will be posted approximately two hours after the event and remain available for 30 days.
Eton Pharmaceuticals (Nasdaq: ETON), a pharmaceutical company specializing in rare disease treatments, announced its participation in the 2025 Wells Fargo Healthcare Conference. The company's executive team will be available for one-on-one meetings during the conference, which takes place from September 3-5, 2025 in Boston, MA.
Interested parties can schedule meetings through their Wells Fargo institutional sales representatives.
Eton Pharmaceuticals (Nasdaq: ETON) reported strong Q2 2025 financial results, with product sales reaching $18.9 million, marking a 108% growth over Q2 2024 and the 18th consecutive quarter of sequential growth. The company posted a GAAP EPS of $(0.10) and non-GAAP EPS of $0.03.
Key highlights include the FDA approval and launch of KHINDIVI™, their eighth commercial product, reaching 100 active INCRELEX® patients ahead of schedule, and strong performance of ALKINDI SPRINKLE® and GALZIN. The company expects to achieve an $80 million annual revenue run rate in Q3 2025, one quarter ahead of previous guidance.
Financial metrics show gross profit of $11.9 million (75% adjusted margin) and Adjusted EBITDA of $3.1 million. The company maintains a strong cash position of $25.4 million and generated $8.0 million in operating cash flow during the quarter.
Eton Pharmaceuticals (Nasdaq: ETON), a pharmaceutical company specializing in rare disease treatments, has scheduled its second quarter 2025 financial results announcement for Thursday, August 7, 2025.
The company will host a conference call and audio webcast at 4:30 p.m. ET to discuss the results. Investors can participate via phone using the dial-in numbers (800) 715-9871 or (646) 307-1963 with Conference ID 5899895, or through the webcast available on Eton's investor relations website. Management will address both live questions and emailed inquiries sent to investorrelations@etonpharma.com.