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 has acquired U.S. and Canadian rights to Crossject’s ZENEO® hydrocortisone needleless autoinjector, designed for emergency treatment of adrenal crisis. This innovative device, covered by 24 U.S. patents, is expected to be the first hydrocortisone autoinjector. Eton plans to submit a New Drug Application to the FDA in 2023 and is targeting orphan drug designation, addressing a market of around 100,000 patients at risk of adrenal crisis. The deal includes up to $11 million in milestone payments and a 10% royalty on net sales.
Eton Pharmaceuticals, Inc. (Nasdaq: ETON) announced the FDA's approval of Rezipres (ephedrine hydrochloride injection) for treating clinically significant hypotension during anesthesia as of June 15, 2021. This marks Eton's second FDA-approved ready-to-use injectable product, enhancing hospital efficiency and safety by reducing reliance on compounded products. The sulfite-free formulation, previously successful in Europe, is set for U.S. market availability soon. Eton currently holds four FDA-approved products and has submitted five more to the FDA.
Eton Pharmaceuticals, Inc. (Nasdaq: ETON) has received a Complete Response Letter (CRL) from the FDA concerning its New Drug Application for dehydrated alcohol injection used in treating methanol poisoning. The FDA's review concluded the application cannot be approved in its current form. A Pre-Approval Inspection of the European manufacturer is pending due to COVID-related travel restrictions. Eton anticipates addressing all FDA queries in a forthcoming response.
Eton Pharmaceuticals, Inc. (Nasdaq: ETON) reported Q1 2021 revenue of $11.9 million, a significant increase from $0.1 million in the prior year, marking its first profitable quarter with operating income of $5.4 million and EPS of $0.19. The company has three commercial products generating revenue and anticipates additional launches from four upcoming PDUFA dates in the next three months. Eton's strong cash position of $25.1 million supports its growth strategy, including the recent successful launch of Alaway Preservative Free and ongoing development of pipeline products.
Eton Pharmaceuticals (Nasdaq: ETON) will release its first quarter 2021 financial and operating results on May 13, 2021. A conference call and audio webcast to discuss these results will be held at 4:30 p.m. ET. Investors can access the live webcast on the company’s investor relations website and listen by dialing specific numbers for domestic and international calls. Eton develops treatments for rare diseases and owns or earns royalties from three FDA-approved products while advancing six additional products submitted to the FDA.
Eton Pharmaceuticals announced the appointment of Jenn Adams to its board of directors, effective March 17, 2021. Ms. Adams brings substantial experience in the pharmaceutical industry, having previously served as CEO of August Bioservices and in senior roles at AmerisourceBergen and Baxter Healthcare. She replaces Mark Baum, who resigned to focus on his role at Harrow Health. Eton's CEO, Sean Brynjelsen, expressed confidence in Adams' ability to support product launches and commercial growth. Eton focuses on developing treatments for rare diseases and has multiple FDA-approved products.
Eton Pharmaceuticals (ETON) reported its financial results for Q4 and full year 2020, revealing a significant net loss of $28.0 million, up from $18.3 million in 2019. The company's revenue was $0.1 million for Q4 2020, largely due to the late launch of ALKINDI SPRINKLE. Notable milestones included the launch of ALKINDI SPRINKLE and Alaway Preservative-Free, with an expectation of over $25 million in revenue for 2021. Eton completed a sale of its neurology portfolio for up to $45 million, enhancing its profitability outlook. However, ongoing high R&D and SG&A expenses remain concerning.
Eton Pharmaceuticals, Inc (Nasdaq: ETON) will announce its fourth quarter and full year 2020 financial results on March 16, 2021, at 4:30 p.m. ET. Management will host a conference call and audio webcast to discuss these outcomes and provide a business update. Interested parties can access the live webcast on Eton's investor section of its website. Eton focuses on developing innovative treatments for rare pediatric diseases and currently has three FDA-approved products and six additional products submitted for FDA review.
Eton Pharmaceuticals, Inc. (Nasdaq: ETON), a company dedicated to innovative treatments for rare pediatric diseases, announced its participation in the 10th Annual SVB Leerink Global Healthcare Conference from February 24-26, 2021. Eton currently has three FDA-approved products, including ALKINDI® SPRINKLE, Biorphen®, and Alaway Preservative Free®, and has six additional products submitted to the FDA. The company emphasized that forward-looking statements regarding its business strategy and product development may be subject to risks and uncertainties.
Eton Pharmaceuticals announced the sale of its neurology portfolio to Azurity Pharmaceuticals for up to $45 million, plus royalties on sales. The portfolio includes drug candidates ET-105, ET-104, and ET-101, which are under FDA review. CEO Sean Brynjelsen highlighted that this deal allows Eton to concentrate on its orphan drug business and improve profitability by avoiding sales force investments. Eton will receive $15 million at closing, with additional payments tied to regulatory and sales milestones.
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