Core Insights - Eton Pharmaceuticals has received U.S. Patent No. 12,214,010 for its ET-600 product candidate, a proprietary formulation of desmopressin oral solution, which is expected to be listed in the FDA's Orange Book upon approval and will remain protected until 2044 [1][3] - ET-600 is being developed specifically for the treatment of diabetes insipidus, addressing a significant unmet need in pediatric care, as current FDA-approved forms do not cater to the precise dosing requirements for children [2][5] - The company is currently conducting a pivotal bioequivalence study for ET-600, with results anticipated by the end of February 2025, and plans to file a New Drug Application (NDA) with the FDA in the second quarter of 2025 if results are favorable [4] Company Overview - Eton Pharmaceuticals focuses on developing and commercializing treatments for rare diseases, with a portfolio that includes seven commercial products and four additional candidates in late-stage development [6]

Core Points - Eton Pharmaceuticals announced that the FDA has extended the PDUFA goal date for the NDA of ET-400 to May 28, 2025, due to the need for additional review time [1][2] - The FDA applied a standard three-month extension from the original goal date of February 28, 2025, following the submission of supplemental information in December [2] - Eton's CEO expressed confidence in the NDA package and does not expect the extension to significantly impact the company's 2025 revenue projections [3] Company Overview - Eton Pharmaceuticals focuses on developing and commercializing treatments for rare diseases, currently offering seven commercial products [4] - The company has four additional product candidates in late-stage development, including ET-400, ET-600, Amglidia®, and ZENEO® hydrocortisone autoinjector [4]

Stock Performance - Eton Pharmaceuticals shares surged 10.8% to close at $16.24 in the last trading session, supported by higher-than-average trading volume [1] - The stock has gained 15.8% over the past four weeks [1] Recent Developments - The company acquired Galzin (zinc acetate), an FDA-approved treatment for Wilson Disease, with plans to commercialize it in the US in Q1 2025 [2] - Eton also secured European rights to the product, marketed as Wilzin in Europe [2] Financial Expectations - Eton is expected to post a quarterly loss of $0.02 per share, representing a 77.8% year-over-year improvement [3] - Revenue is projected at $10.68 million, up 46.1% from the year-ago quarter [3] - The consensus EPS estimate has been revised 20% lower over the last 30 days [4] Industry Context - Eton operates in the Zacks Medical - Biomedical and Genetics industry [4] - Legend Biotech, another company in the same industry, saw its shares rise 0.7% to $37.69 in the last session [4] - Legend Biotech has returned 14.2% over the past month [4] - Legend Biotech's consensus EPS estimate for the upcoming report has changed -2.4% to -$0.32, representing a 20% improvement from the year-ago period [5]

Core Insights - Eton Pharmaceuticals has acquired Galzin® (zinc acetate), a medication for Wilson Disease, enhancing its portfolio in rare disease treatments [1][2][7] - The acquisition aligns with Eton's mission to support life-saving treatments for ultra-rare patient populations [2] Company Overview - Eton Pharmaceuticals is focused on developing and commercializing treatments for rare diseases, currently offering six commercial products and four additional candidates in late-stage development [12] Product Details - Galzin is FDA-approved for maintenance treatment of Wilson Disease patients who have been initially treated with a chelating agent, with an estimated patient population of less than 5,000 in the U.S. [3][4] - Eton plans to commercialize Galzin in the U.S. in Q1 2025, supported by its metabolic sales force and the Eton Cares patient support program [4] Patient Support Program - The Eton Cares program will provide a $0 co-pay for qualified commercial patients, prescription fulfillment, insurance benefits investigation, and educational support [4] European Rights - Eton has acquired European rights to Galzin, where it is marketed as Wilzin® by a third party, with Eton continuing to supply the product under an existing distribution agreement [5]

Core Insights - Eton Pharmaceuticals has completed the acquisition of Increlex® (mecasermin injection) from Ipsen S.A., enhancing its portfolio in pediatric endocrinology [1][16] - Increlex® is the only FDA and EMA approved treatment for severe primary insulin-like growth factor 1 deficiency (SPIGFD) in pediatric patients aged 2 years and older [2][25] - The product is now available in the U.S. through AnovoRx, a specialty pharmacy, which will also manage the Eton Cares Program to assist patients [17][16] Group 1: Acquisition Details - The acquisition was financed using Eton's cash reserves and an expansion of its existing credit facility with SWK Holdings [3] - Ipsen will continue to distribute Increlex® outside the U.S. for a six-month transition period before Eton takes over commercialization [3] Group 2: Product Information - Increlex® is approved in 41 territories, including the U.S. and EU, with an estimated 200 patients in the U.S. and 900-1,000 in Europe suffering from SPIGFD [2] - The product is indicated for growth failure in pediatric patients with severe primary IGF-1 deficiency, defined by specific height and IGF-1 level criteria [25][26] Group 3: Patient Support and Accessibility - The Eton Cares Program will provide prescription fulfillment, insurance benefits investigation, educational support, and financial assistance for qualifying patients [17] - Co-pay assistance will be available to allow for $0 co-pays for eligible patients [17]

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].

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, ...

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 ...

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Eton Pharmaceuticals, Inc. (NASDAQ:ETON) Q3 2024 Earnings Conference Call November 12, 2024 4:30 PM ET Company Participants David Krempa – Chief Business Officer Sean Brynjelsen – Chief Executive Officer James Gruber – Chief Financial Officer Conference Call Participants Chase Knickerbocker – Craig-Hallum Operator Good afternoon, and welcome to the Eton Pharmaceuticals Third Quarter 2024 Financial Results Conference Call. At this time, all participants are in listen-only mode. Following the formal remarks, ...