Welcome to our dedicated page for Eton Pharmaceutcials news (Ticker: ETON), a resource for investors and traders seeking the latest updates and insights on Eton Pharmaceutcials stock.
Eton Pharmaceuticals, Inc. (NASDAQ: ETON) is a Deer Park, Illinois-based specialty pharmaceutical company dedicated to developing and commercializing innovative pharmaceutical products, particularly those aimed at treating rare diseases. The company's mission is to advance healthcare by introducing affordable and accessible medicines to patients in need.
Eton utilizes the U.S. Food and Drug Administration’s (FDA) 505(b)(2) regulatory pathway to develop its products. Currently, Eton has four commercial rare disease products: ALKINDI SPRINKLE® for pediatric adrenocortical insufficiency, Carglumic Acid for hyperammonemia, Betaine Anhydrous for homocystinuria, and Nitisinone for hereditary tyrosinemia type 1 (HT-1). The recent addition of Nitisinone further advances Eton's goal of having ten commercial rare disease products by the end of 2025.
Beyond these, Eton has several promising candidates in late-stage development. These include ET-400, a liquid formulation of hydrocortisone for adrenocortical insufficiency, the ZENEO® hydrocortisone autoinjector for adrenal crisis, and ET-600 for diabetes insipidus. Eton's ET-400 product recently received a new U.S. patent with an expiration date in 2043, and it is expected to significantly complement the existing ALKINDI SPRINKLE product.
Financial Performance and Recent Achievements
- The company has reported eleven consecutive quarters of growth in product sales and royalty revenue, achieving cash flow break-even ahead of schedule.
- Third quarter 2023 net revenue reached $7.0 million, marking a 118% increase from the prior year period.
- Gross profit for the same quarter more than doubled year-over-year, underscoring the company's strong commercial execution.
Eton's strategic acquisitions further bolster its portfolio. The recent acquisition of U.S. rights to PKU GOLIKE® from Relief Therapeutics positions the company to address the needs of patients with phenylketonuria (PKU), a rare metabolic disorder. Eton also aims to leverage its strong relationships within the metabolic community to drive adoption and market penetration for both existing and new products.
Patient Support and Community Initiatives
Eton is committed to supporting patients and their families through initiatives like the Eton Cares program, which provides comprehensive support services including prescription fulfillment, insurance benefits investigation, educational support, and financial assistance for qualified patients. The program aims to make treatments like Nitisinone more accessible to those who need them the most.
Looking Ahead
With a robust pipeline, strategic acquisitions, and a strong financial footing, Eton Pharmaceuticals is well-positioned for continued growth and success. The company's focus on rare diseases and commitment to patient care make it a valuable player in the pharmaceutical industry.
For more detailed information, please visit the company's website at www.etonpharma.com.
Eton Pharmaceuticals reported Q4 2022 revenue of $8.5 million, a 39% increase from $6.1 million a year earlier. Product sales and royalty revenue surged 220% year-over-year. Net income for the quarter was $0.9 million, down slightly from $1.0 million in Q4 2021. The company experienced eighth consecutive quarters of revenue growth, primarily driven by ALKINDI SPRINKLE and Carglumic Acid. Eton has also expanded its sales force to further boost growth and plans to launch Betaine soon. Upcoming milestones include an NDA filing for a rare disease candidate, ET-600, in Q2 2024, and preparing for dehydrated alcohol injection launch.
Eton Pharmaceuticals (Nasdaq: ETON) announced the acquisition of rare disease product candidate ET-600 from Tulex Pharmaceuticals, targeting a rare pediatric endocrinology condition affecting fewer than 5,000 patients in the U.S. This acquisition aligns with Eton's strategy to expand its pediatric endocrinology portfolio. An NDA submission is anticipated in Q2 2024, potentially leading to product approval and launch in early 2025. If successful, ET-600 may provide a patent-protected revenue stream, bolstering long-term profitability for the company.
Eton Pharmaceuticals, Inc. (Nasdaq: ETON) is set to report its fourth quarter 2022 financial results on March 16, 2023, during a conference call at 4:30 p.m. ET. The call will be accessible via a live audio webcast for investors and includes a segment for emailed questions.
Eton is focused on treatments for rare diseases and currently has three FDA-approved products: ALKINDI SPRINKLE®, Carglumic Acid tablets, and Betaine Anhydrous for Oral Solution. The company is also developing three late-stage pipeline candidates and receives royalties from other FDA-approved products.
Eton Pharmaceuticals (ETON) announced the FDA's acceptance of its New Drug Application (NDA) for dehydrated alcohol injection, aimed at treating methanol poisoning. The application has a PDUFA date set for June 27, 2023. Previously granted orphan drug designation, this product could provide Eton with seven years of exclusivity upon approval. The pharmaceutical market for dehydrated alcohol injection is significant, with trailing twelve-month sales reaching $74 million.
Eton Pharmaceuticals reported strong Q3 2022 results with revenues reaching $3.2 million, a 315% increase year-over-year and 37% sequential growth. The company attributes this success to robust sales of ALKINDI SPRINKLE® and Carglumic Acid, showing growth rates of 183% and 40% respectively. Eton also acquired Betaine Anhydrous, expanding its rare disease portfolio. Despite a net loss of $3 million for the quarter, the company's cash position stood at $13.4 million as of September 30, 2022. A $5 million milestone payment is expected from the launch of Zonisade™.
Eton Pharmaceuticals, Inc. (Nasdaq: ETON) announced its plan to release third quarter 2022 financial results on November 10, 2022. The management will host a conference call at 4:30 p.m. ET to discuss the results, with live audio accessible via the company's investor relations website. Participants are required to register for dial-in details, enhancing security and streamlining access. Eton specializes in developing treatments for rare diseases and currently has three FDA-approved products, along with several candidates in late-stage development.
Eton Pharmaceuticals (Nasdaq: ETON) announced that CEO Sean Brynjelsen will present at the LD Micro Main Event XV Conference on October 26, 2022, at 6:00 PM ET. The event will be available via webcast on the company's website in the Investors section. Eton focuses on developing treatments for rare diseases and currently markets ALKINDI SPRINKLE® and Carglumic Acid tablets, with several additional products under development. For more information, visit www.etonpharma.com.
Eton Pharmaceuticals (Nasdaq: ETON) announced the acquisition of betaine anhydrous for oral solution, enhancing its portfolio focused on rare diseases. This FDA-approved product targets fewer than 2,000 patients in the U.S. with a market estimated at $10 million annually. CEO Sean Brynjelsen highlighted that the acquisition is expected to be accretive to 2023 earnings and aligns with their strategy to commercialize treatments for underserved populations. Eton plans to integrate the product later this year.
Eton Pharmaceuticals (Nasdaq: ETON) announced that CEO Sean Brynjelsen will present at the H.C. Wainwright 24th Annual Global Investment Conference on September 14, 2022, at 1:30 PM ET. The presentation will be available via webcast on the company's investor relations website. Eton focuses on developing treatments for rare diseases and currently markets products like ALKINDI SPRINKLE® and Carglumic Acid tablets. The company has additional rare disease products in development and is entitled to milestone payments or royalties on several products.
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