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Eton Pharmaceuticals Announces Final Readout of PKU GOLIKE® Clinical Trial
Newsfilter· 2024-12-17 11:50
Core Insights - Eton Pharmaceuticals announced positive results from a clinical trial of PKU GOLIKE, a protein substitute for treating phenylketonuria (PKU), showing improved metabolic control during prolonged fasting periods [1][5]. Clinical Trial Details - The study was a randomized, crossover, controlled trial conducted on pediatric patients with classical PKU at Birmingham Children's Hospital, UK, comparing PKU GOLIKE to standard amino acid substitutes [3]. - Results indicated a statistically significant reduction in blood phenylalanine (Phe) levels by an average of 17.8% and an increase in blood tyrosine (Tyr) levels by an average of 33.8% in the PKU GOLIKE group compared to standard substitutes [4]. Clinical Significance - The principal investigator highlighted that administering PKU GOLIKE as the final daily dose led to better metabolic control in patients, confirming its prolonged-release profile's effectiveness [5]. - The findings are expected to support the adoption of PKU GOLIKE among healthcare providers and the PKU community [5]. Product Information - PKU GOLIKE is a food for special medical purposes designed for dietary management of PKU, utilizing a proprietary drug delivery platform that mimics natural protein absorption [12]. - The product line includes various forms, such as flavorless granules and medical formula bars, and has been commercially available in the U.S. since October 2022 [12]. Future Presentation - The study findings will be presented at the 2025 American College of Medical Genetics and Genomics Annual Clinical Genetics Meeting in Los Angeles [6].
Eton Pharmaceuticals Appoints Ipek Erdogan-Trinkaus as Chief Commercial Officer
GlobeNewswire News Room· 2024-12-03 11:50
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 pharmaceutical company focused on developing and commercializing treatments for rare diseases, ...
Eton Pharmaceuticals Announces Acquisition of U.S. Rights to Amglidia (Glyburide Oral Suspension)
GlobeNewswire News Room· 2024-11-25 11:50
Amglidia® has been approved by the European Medicines Agency (EMA) and is commercially available in EuropeStrong strategic fit with Eton’s existing pediatric endocrinology focusAmglidia 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 “Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and c ...
What Makes Eton Pharmaceuticals (ETON) a Good Fit for 'Trend Investing'
ZACKS· 2024-11-18 14:50
Most of us have heard the dictum "the trend is your friend." And this is undeniably the key to success when it comes to short-term investing or trading. But it isn't easy to ensure the sustainability of a trend and profit from it.The trend often reverses before exiting the trade, leading to a short-term capital loss for investors. So, for a profitable trade, one should confirm factors such as sound fundamentals, positive earnings estimate revisions, etc. that could keep the momentum in the stock alive.Our " ...
Eton Pharmaceuticals Reports Third Quarter 2024 Financial Results
GlobeNewswire News Room· 2024-11-12 21:01
Reported total revenue of $10.3 million and GAAP Net Income of $0.6 million, or $0.02 per diluted shareEntered into an asset purchase agreement to acquire Increlex® (mecasermin injection)Q3 2024 product sales increased 40% over Q3 2023, representing 15th straight quarter of sequential product sales growthProduced positive quarterly GAAP net income from product sales for first time in company historyGenerated cash from operations of $2.9 million in Q3 2024Granted additional patent for ET-400Management to hol ...
Eton Pharmaceuticals to Report Third Quarter 2024 Financial Results on Tuesday, November 12, 2024
GlobeNewswire News Room· 2024-11-06 21:30
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). Dial in (Audio Only) Toll-free: 888-596-4144  Non-toll free: 6 ...
Eton Pharmaceuticals to Report Second Quarter 2024 Financial Results on Thursday, August 8, 2024
Newsfilter· 2024-07-30 21:30
In addition to taking live questions from participants on the conference call, management will be answering emailed questions from investors. Investors can email questions to: investorrelations@etonpharma.com. Lisa M. Wilson In-Site Communications, Inc. T: 212-452-2793 E: lwilson@insitecony.com 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 ra ...
Eton Pharmaceuticals to Report Second Quarter 2024 Financial Results on Thursday, August 8, 2024
GlobeNewswire News Room· 2024-07-30 21:30
The live webcast can also be accessed on the Investors section of Eton's website at https://ir.etonpharma.com/. An archived webcast will be available on Eton's website approximately two hours after the completion of the event and for 30 days thereafter. About Eton Pharmaceuticals Investor Relations: Source: Eton Pharmaceuticals 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 ...
Eton Pharmaceuticals Announces FDA Acceptance of New Drug Application for ET-400 (Hydrocortisone Oral Solution)
Newsfilter· 2024-07-15 20:05
- Prescription Drug User Fee Act (PDUFA) target action date is February 28, 2025 - 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 proprietary patented formulation of hydrocortisone oral solution, has been accepted by the U.S. Food and Drug Administration (FDA) ...
Eton Pharmaceuticals(ETON) - 2024 Q1 - Quarterly Report
2024-05-09 20:25
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________________ to _______________________ Commission file number: 001-38738 ETON PHARMACEUTICALS, INC. (Exact name of registrant as speci ...