Core Insights - Eton Pharmaceuticals has launched Galzin (zinc acetate) capsules, the only FDA-approved zinc therapy for Wilson disease, aimed at expanding patient access to this critical treatment [1][8] - The company offers a $0 co-pay for all eligible patients and has established the Eton Cares patient support services to facilitate access to Galzin [1][3] Company Overview - Eton Pharmaceuticals focuses on developing and commercializing treatments for rare diseases, currently offering seven commercial products and four additional candidates in late-stage development [8] Product Launch Details - Galzin is now available exclusively through Optime Care, a specialty pharmacy that will administer the Eton Cares Program, providing various support services including prescription fulfillment and financial assistance [3][4] - The launch aims to address historical challenges in availability and affordability, encouraging patients to use the approved medication instead of unapproved alternatives [2] Patient Support Initiatives - Eton Cares will ensure that eligible patients have access to Galzin with comprehensive support services, including educational resources and insurance benefits investigation [3][2] - The program is designed to enhance awareness and access to Galzin within the Wilson disease community [2] Clinical Information - Galzin is indicated for the maintenance treatment of Wilson disease patients who have been initially treated with a chelating agent [8] - Patients are advised to take Galzin on an empty stomach and must be clinically monitored for the adequacy of therapy [10]

Core Viewpoint - The article emphasizes the importance of confirming the sustainability of a trend in short-term investing, highlighting that successful entry timing is crucial for profitability [1][2]. Group 1: Trend Analysis - The trend can reverse before exiting a trade, potentially leading to short-term capital losses for investors [2]. - A stock's recent price strength is a key indicator of its potential to maintain upward momentum, with Eton Pharmaceuticals, Inc. (ETON) being highlighted for its significant price increase of 64.5% over 12 weeks [4]. - ETON has also shown a price increase of 28.7% over the past four weeks, indicating that the upward trend is still intact [5]. Group 2: Fundamental Strength - ETON is currently trading at 92.6% of its 52-week high-low range, suggesting it may be on the verge of a breakout [5]. - The stock carries a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises [6]. - The Average Broker Recommendation for ETON is 1 (Strong Buy), reflecting high optimism from the brokerage community regarding its near-term price performance [7]. Group 3: Investment Strategy - The article suggests that investors should consider stocks that pass the "Recent Price Strength" screen, which identifies stocks with strong fundamentals and upward price trends [3][8]. - The Zacks Rank stock-rating system has a proven track record, with Zacks Rank 1 stocks generating an average annual return of +25% since 1988 [7].

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]

Acquisition bolsters Eton’s commercial pediatric endocrinology portfolioProduct 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, today announced that it has completed its previously announced asset purchase of Incre ...

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 periods. The study demonstrated that PKU GOLIKE, administered as the last daily dose ...

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 ...