NDA assigned a Target Action Date of February 25, 2026 Product has patent protection through 2044 DEER PARK, Ill., July 08, 2025 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (“Eton” or the “Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced the Company’s New Drug Application (NDA) for ET-600, a proprietary patented... Read More

DEER PARK, Ill., June 27, 2025 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (“Eton” or the “Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced that it will be added to the broad-market Russell 3000 ® and small-cap Russell 2000 ® Indexes, effective after the U.S. market closes on June 27, as part of the 2025 Russell Indexes... Read More

KHINDIVI is the first and only FDA-approved hydrocortisone oral solution Commercial launch expected the week of June 2 nd Eton expects combined peak sales of KHINDIVI and ALKINDI SPRINKLE® (hydrocortisone) oral granules to exceed $50 million DEER PARK, Ill., May 28, 2025 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (“Eton” or “the Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and... Read More

DEER PARK, Ill., May 14, 2025 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (“Eton” or the “Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced that Sean Brynjelsen, Chief Executive Officer, James Gruber, Chief Financial Officer, and David Krempa, Chief Business Officer, will participate in two upcoming investor conferences as... Read More

Q1 2025 revenue of $17.3 million, with product sales of $14.0 million, representing 76% growth over Q1 2024 and the 17 th straight quarter of sequential product sales growth Q1 2025 basic and fully diluted GAAP EPS of $(0.06), Non-GAAP fully diluted EPS of $0.07, and Adjusted EBITDA of $3.7 million Relaunched pediatric endocrinology biologic INCRELEX® in the U.S. and out-licensed international rights Established Wilson... Read More

DEER PARK, Ill., May 01, 2025 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (“Eton” or the “Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced that it will report first quarter 2025 financial results on Tuesday, May 13, 2025. Management will host a conference call and live audio webcast to discuss the results at 4:30 p.m. ET... Read More

NDA submitted for the treatment of central diabetes insipidus Expected 10-month review; commercial preparations underway for a potential Q1 2026 launch DEER PARK, Ill., April 28, 2025 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (“Eton” or the “Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced the submission of a New Drug... Read More

DEER PARK, Ill., April 01, 2025 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (“Eton” or the “Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced the out-licensing of commercial rights to Increlex® in territories outside of the U.S. to Esteve Pharmaceuticals, S.A. (“Esteve”). “Esteve shares Eton’s dedication to putting patients... Read More

Management to Hold Investor Day Conference Call Today at 10:00am ET Reported record product revenue of $11.6 million in Q4 2024, an increase of 59% over Q4 2023, representing the 16 th straight quarter of sequential product sales growth Closed the transformational acquisition of pediatric endocrinology biologic Increlex® and relaunched the product in January Acquired and relaunched ultra rare disease product Galzin® Licensed... Read More

Company’s patented desmopressin oral solution successfully passed pivotal bioequivalence study Company expects to submit New Drug Application (NDA) in April 2025 DEER PARK, Ill., March 14, 2025 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (“Eton” or the “Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced positive results from... Read More

DEER PARK, Ill., March 04, 2025 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc. (“Eton” or the "Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced that it will hold a virtual Investor Day and report fourth quarter 2024 financial results on Tuesday, March 18, 2025, beginning at 10:00 a.m. ET (9:00 a.m. CT). In addition to... Read More

Eton expects to significantly expand patient access to this critical treatment for Wilson disease patients $0 co-pay for all eligible patients and best-in-class patient support services Now available exclusively through Optime Care DEER PARK, Ill., March 03, 2025 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (“Eton” or the “Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and... Read More

Product has patent protection through 2044 Expected to be listed in the U.S. Food and Drug Administration’s (FDA) Orange Book upon the product’s approval DEER PARK, Ill., Feb. 07, 2025 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (“Eton” or the “Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced that the United States Patent... Read More

DEER PARK, Ill., Feb. 06, 2025 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (“Eton” or the “Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for the New Drug Application (NDA) for ET-400. The new PDUFA goal... Read More

Adds an additional commercial and strategic rare disease product to Eton’s portfolio Galzin is FDA-approved for the treatment of the ultra-rare metabolic condition of Wilson Disease DEER PARK, Ill., Jan. 03, 2025 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (“Eton” or the “Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced... Read More

Acquisition bolsters Eton’s commercial pediatric endocrinology portfolio Product is now available through AnovoRx, a specialty pharmacy dedicated to serving patients with rare and chronic conditions DEER PARK, Ill., Dec. 20, 2024 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (“Eton” or “the Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases,... Read More

DEER PARK, Ill., Dec. 17, 2024 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc. (“Eton” or the “Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases announced the full readout and compelling results from the clinical trial evaluating PKU GOLIKE as a protein substitute for the treatment of phenylketonuria (PKU) in patients during prolonged fasting... Read More

Ms. Erdogan-Trinkaus brings a wealth of commercial leadership and expertise in sales and marketing from her tenure at leading global pharmaceutical companies and across the broader health and wellness sector, including significant experience in the pediatric endocrinology specialty. DEER PARK, Ill., Dec. 03, 2024 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (“Eton” or the “Company”) (Nasdaq: ETON), an innovative... Read More

Amglidia® has been approved by the European Medicines Agency (EMA) and is commercially available in Europe Strong strategic fit with Eton’s existing pediatric endocrinology focus Amglidia has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) Potential New Drug Application (NDA) submission in 2026 DEER PARK, Ill., Nov. 25, 2024 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (“Eton” or the... Read More

Reported total revenue of $10.3 million and GAAP Net Income of $0.6 million, or $0.02 per diluted share Entered into an asset purchase agreement to acquire Increlex® (mecasermin injection) Q3 2024 product sales increased 40% over Q3 2023, representing 15 th straight quarter of sequential product sales growth Produced positive quarterly GAAP net income from product sales for first time in company history Generated cash from... Read More

Product has patent protection through 2043 Prescription Drug User Fee Act (PDUFA) target action date of February 28, 2025 DEER PARK, Ill., Nov. 07, 2024 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (“Eton” or the “Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced that the United States Patent and Trademark Office (USPTO) has... Read More

DEER PARK, Ill., Nov. 06, 2024 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc. (“Eton” or the "Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced that it will report third quarter 2024 financial results on Tuesday, November 12, 2024. Management will host a conference call and live audio webcast to discuss the results at 4:30... Read More

Aligns with Eton's Mission to Develop and Distribute Medicines that Have a Life Changing Impact for Patients with Ultra-rare Conditions Acquisition to Bolster Eton’s Commercial Pediatric Endocrinology Portfolio DEER PARK, Ill., Oct. 03, 2024 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (“Eton” or “the Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare... Read More

DEER PARK, Ill., Aug. 22, 2024 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (“Eton” or the “Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, announced today that the Company will participate at the H.C. Wainwright 26 th Annual Global Investment Conference in New York City. The Company’s presentation by Sean Brynjelsen, Chief Executive... Read More

Product sales and royalty revenue of $9.1 million, representing 40% growth over Q2 2023 and the 14 th straight quarter of sequential product sales growth New drug application (NDA) for ET-400 accepted by the U.S. Food and Drug Administration (FDA) and assigned a February 28, 2025 PDUFA date Q2 2024 Cash Flow from Operations of $1.3 million, including the payment of one-time $2.0 million NDA filing fee for ET-400 Management... Read More

DEER PARK, Ill., July 30, 2024 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc. (“Eton” or the "Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced that it will report second quarter 2024 financial results on Thursday, August 8, 2024. Management will host a conference call and live audio webcast to discuss the results at 4:30... Read More

- Prescription Drug User Fee Act (PDUFA) target action date is February 28, 2025 - - Product has patent protection through 2043 - DEER PARK, Ill., July 15, 2024 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (“Eton” or the “Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced the Company’s New Drug Application (NDA) for ET-400, a... Read More

Q1 2024 revenue of $8.0 million, representing 50% growth over Q1 2023 and the 13 th straight quarter of sequential product sales growth Acquired PKU GOLIKE®, launched Nitisinone, and submitted a new drug application (NDA) for product candidate ET-400 Management to hold conference call today at 4:30pm ET DEER PARK, Ill., May 09, 2024 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (“Eton” or “the Company”) (Nasdaq: ETON), an... Read More

DEER PARK, Ill., May 01, 2024 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, announced today that Sean Brynjelsen, Chief Executive Officer, and James Gruber, Chief Financial Officer, will present at the Citizens JMP Life Sciences Conference in New York as follows: Date: Monday, May 13, 2024 Time:... Read More

Company anticipates 10-month review for potential approval in Q1 2025 Eton expects ET-400 and Alkindi Sprinkle ® to achieve potential combined peak sales of more than $50 million annually Product has patent protection through 2043 DEER PARK, Ill., April 30, 2024 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (“Eton” or the “Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and... Read More

DEER PARK, Ill., April 29, 2024 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc. (“Eton” or the "Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced that it will report first quarter 2024 financial results on Thursday, May 9, 2024. Management will host a conference call and live audio webcast to discuss the results at 4:30 p.m.... Read More

PKU GOLIKE® is a commercial ultra-rare disease medical formula complementary to Eton's existing metabolic franchise and specialty call point Transaction is expected to be accretive to 2024 earnings Estimated peak sales of more than $10 million annually U.S. phenylketonuria ("PKU") medical formula market estimated to be $100 million annually DEER PARK, Ill., March 22, 2024 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (“Eton”... Read More

Q4 2023 revenue of $7.3 million, representing a 109% increase from Q4 2022, marking the twelfth consecutive quarter of sequential product sales growth Full year 2023 revenues reached $31.6 million with product sales and royalty revenues of $26.1 million, a 132% increase from 2022 Announced successful results from ET-400’s pivotal bioequivalence study, NDA submission planned for Q2 2024 Management to hold conference call... Read More

DEER PARK, Ill., Feb. 29, 2024 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc. (“Eton” or the "Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced that it will report fourth quarter and full year 2023 financial results on Thursday, March 14, 2024. Management will host a conference call and live audio webcast to discuss these... Read More

DEER PARK, Ill., Feb. 21, 2024 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals (“Eton” or the “Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced that the United States Patent and Trademark Office (“USPTO”) has granted the Company’s U.S. Patent Application No. 18/113,458, which covers the Company’s ET-400 product candidate’s... Read More

Eton Cares patient support program offers $0 co-pay to eligible, commercially insured patients* Current Nitisinone market is estimated to exceed $50 million annually Product is now available exclusively through Optime Care DEER PARK, Ill., Feb. 02, 2024 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals (“Eton” or “the Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing, acquiring, and commercializing... Read More

Product sales and royalty revenue of $7.0 million up 118% from Q3 2022, representing the eleventh straight quarter of sequential product sales and royalty revenue growth Generated $0.9 million in positive cash flow from operations; ended quarter with $22.1 million of cash on hand Acquired ultra-rare disease product Nitisinone Capsules Management to hold conference call today at 4:30pm ET DEER PARK, Ill., Nov. 09, 2023 (GLOBE... Read More

DEER PARK, Ill., Oct. 30, 2023 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc. (Nasdaq: ETON), an innovative pharmaceutical company focused on developing, acquiring, and commercializing products to address unmet needs in patients suffering from rare diseases, today announced that it will report third quarter 2023 financial results on Thursday, November 9, 2023. Management will host a conference call and live audio webcast to... Read More

Expect Q1 2024 product launch Nitisinone market estimated to be more than $50 million annually Eton will offer Eton Cares support program to all patients DEER PARK, Ill., Oct. 04, 2023 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals (“Eton” or “the Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing, acquiring, and commercializing products to address unmet needs in patients suffering from rare... Read More

DEER PARK, Ill., Aug. 23, 2023 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, announced today that Sean Brynjelsen, Chief Executive Officer, will present at the H.C. Wainwright 25 th Annual Global Investment Conference in New York City as follows: Date: Wednesday, September 13, 2023 Time: 9:00am ET To... Read More

Total Q2 revenue of $12.0 million and net income of $4.6 million Product sales and royalty revenue of $6.5 million up 175% from Q2 2022 and 22% from Q1 2023 $21.6 million of cash on hand Launched Betaine Anhydrous Management to hold conference call today at 4:30pm ET DEER PARK, Ill., Aug. 10, 2023 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (“Eton” or “the Company”) (Nasdaq: ETON), an innovative pharmaceutical company... Read More

DEER PARK, Ill., Aug. 01, 2023 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc. (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced that it will report second quarter 2023 financial results on Thursday, August 10, 2023. Management will host a conference call and live audio webcast to discuss these results at 4:30 p.m. ET (3:30 p.m. CT).... Read More

DEER PARK, Ill., June 28, 2023 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, announced today that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) in response to its New Drug Application (NDA) for dehydrated alcohol injection for the treatment of methanol poisoning.... Read More

Product sales and royalty revenue of $5.3 million up 144% from Q1 2022 and 52% from Q4 2022 Launched Betaine Anhydrous Management to hold conference call today at 4:30pm ET DEER PARK, Ill., May 11, 2023 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (“Eton” or “the Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today reported financial... Read More

Eton Cares patient support program offers $0 co-pay to eligible, commercially insured patients* Product is now available exclusively through Optime Care DEER PARK, Ill., May 10, 2023 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced the commercial availability of Betaine Anhydrous for Oral... Read More

DEER PARK, Ill., May 03, 2023 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc. (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced that it will report first quarter 2023 financial results on Thursday, May 11, 2023. Management will host a conference call and live audio webcast to discuss these results at 4:30 p.m. ET (3:30 p.m. CT).... Read More

Q4 2022 revenue of $8.5 million Q4 Product sales and royalty revenue up 220% from prior year and 9% from Q3 Q4 positive net income Management to hold conference call today at 4:30pm ET DEER PARK, Ill., March 16, 2023 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (“Eton” or “the Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today reported... Read More

Product is targeting rare pediatric endocrinology condition Potential for NDA submission in Q2 2024 DEER PARK, Ill., March 15, 2023 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals (“Eton” or “the Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced the acquisition of rare disease product candidate ET-600 from Tulex Pharmaceuticals.... Read More

DEER PARK, Ill., March 07, 2023 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc. (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced that it will report fourth quarter 2022 financial results on Thursday, March 16, 2023. Management will host a conference call and live audio webcast to discuss these results at 4:30 p.m. ET (3:30 p.m. CT).... Read More

Product previously granted orphan drug designation for methanol poisoning Application assigned a PDUFA date of June 27, 2023 DEER PARK, Ill., Jan. 11, 2023 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals (“Eton” or “the Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted... Read More