Articles from Eton Pharmaceuticals

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).

– 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 –

- 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. 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 date is May 28, 2025.

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 that it has acquired Galzin® (zinc acetate).

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, today announced that it has completed its previously announced asset purchase of Increlex® (mecasermin injection) from Ipsen S.A. (“Ipsen”). Increlex® is a biologic product used to treat pediatric patients 2 years of age and older who suffer from severe primary insulin-like growth factor 1 deficiency (SPIGFD).

Clinical Trial Demonstrates Clinical and Statistical Improvement in Metabolic Control During Prolonged Fasting in PKU Patients - Results Expected to Promote Awareness and Adoption of PKU GOLIKE®

DEER PARK, Ill., Nov. 25, 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 has acquired the U.S. rights to Amglidia (glyburide oral suspension, known as glibenclamide in Europe) for the treatment of neonatal diabetes mellitus from AMMTeK.

DEER PARK, Ill., Nov. 12, 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 reported financial results for the quarter ended September 30, 2024.

- Product has patent protection through 2043 -- Prescription Drug User Fee Act (PDUFA) target action date of February 28, 2025 -

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 p.m. ET (3:30 p.m. CT).

Aligns with Eton's Mission to Develop and Distribute Medicines that Have a Life Changing Impact for Patients with Ultra-rare Conditions

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 26th Annual Global Investment Conference in New York City.

DEER PARK, Ill., Aug. 08, 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 reported financial results for the quarter ended June 30, 2024.

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 p.m. ET (3:30 p.m. CT).

- Prescription Drug User Fee Act (PDUFA) target action date is February 28, 2025 -

•  Q1 2024 revenue of $8.0 million, representing 50% growth over Q1 2023 and the 13th 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 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:

- 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 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. ET (3:30 p.m. CT).

DEER PARK, Ill., March 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, today announced that it has acquired U.S. rights to PKU GOLIKE® from RELIEF THERAPEUTICS Holding SA (“Relief”) (SIX: RLF, OTCQB: RLFTF, RLFTY).

DEER PARK, Ill., March 14, 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 reported financial results for the quarter and year ended December 31, 2023.

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 results at 4:30 p.m. ET (3:30 p.m. CT).

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 proprietary formulation of oral liquid hydrocortisone. The patent has an expiration in 2043 and is expected to be listed in the FDA’s Orange Book upon the product’s approval. The Company has additional patent applications related to the product under review with the USPTO.

-- 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., Nov. 09, 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 results for the quarter ended September 30, 2023.

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 discuss these results at 4:30 p.m. ET (3:30 p.m. CT).

-- 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., 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 25th Annual Global Investment Conference in New York City as follows:

DEER PARK, Ill., Aug. 10, 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 results for the quarter ended June 30, 2023.

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).

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. The issues raised in the CRL relate primarily to Chemistry Manufacturing and Controls (CMC). The Company believes all issues in the CRL are addressable and will develop a comprehensive action plan to address the FDA’s concerns.

-- 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 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).

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 financial results for the quarter ended December 31, 2022.

-- Product is targeting rare pediatric endocrinology condition ---- Potential for NDA submission in Q2 2024 --

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).

-- Product previously granted orphan drug designation for methanol poisoning ---- Application assigned a PDUFA date of June 27, 2023 --

DEER PARK, Ill., Nov. 10, 2022 (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 results for the quarter ended September 30, 2022.

DEER PARK, Ill., Nov. 02, 2022 (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 third quarter 2022 financial results on Thursday, November 10, 2022. 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).

DEER PARK, Ill., Oct. 18, 2022 (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 Sean Brynjelsen, Chief Executive Officer, will present at the LD Micro Main Event XV Conference as follows: