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, Inc. (Nasdaq: ETON) has announced the acquisition of Canadian rights to ALKINDI® SPRINKLE from Diurnal Group plc. This product is crucial for treating Adrenocortical Insufficiency in children under 17. Following its positive reception in the U.S., Eton aims to expand into the Canadian market, addressing significant unmet needs among pediatric patients. The acquisition reflects Eton's commitment to becoming a leader in orphan drug development, as noted by both Eton and Diurnal executives.
Eton Pharmaceuticals has received FDA acceptance for its new drug application (NDA) for topiramate oral solution, targeting pediatric and adolescent patients. The application, which includes three indications for seizures and migraine prevention, has a PDUFA date of August 6, 2021. This marks a significant step for Eton, which has three neurology-focused oral liquid products submitted to the FDA, all slated for approval in 2021. The company currently has three FDA-approved products and aims to develop treatments for rare pediatric diseases.
Eton Pharmaceuticals, Inc. (Nasdaq: ETON) announces the exclusive availability of ALKINDI® SPRINKLE through AnovoRx Specialty Pharmacy. This FDA-approved treatment is designed for pediatric patients with Adrenocortical Insufficiency (AI), and provides dosing flexibility with strengths of 0.5 mg to 5 mg. The Eton Cares Program will assist patients in accessing this medication. Eton estimates that AI affects between 5,000 and 11,000 children in the U.S.
Eton Pharmaceuticals, Inc. (Nasdaq: ETON) reported Q3 2020 financial results, revealing a revenue of ($0.2) million, attributed to a price reduction of Biorphen. SG&A expenses rose to $3.4 million, while R&D expenses decreased to $2.8 million. The net loss increased to $6.5 million compared to $5.0 million a year ago. Eton successfully closed an oversubscribed equity offering raising approximately $22.5 million. Key milestones include the FDA approval of ALKINDI SPRINKLE, expected to launch by November, and four NDAs submitted with upcoming PDUFA dates in 2021.
Eton Pharmaceuticals (ETON) announced it will release its third quarter 2020 financial and operational results on November 12, 2020. A conference call to discuss these results and provide a business update is scheduled for 4:30 p.m. ET. The call can be accessed domestically at 1-866-795-8473 and internationally at 1-470-495-9161. Eton specializes in innovative treatments for rare pediatric diseases and has three FDA-approved products, with six additional products in late-stage development, five of which are submitted to the FDA.
Eton Pharmaceuticals, Inc. (Nasdaq: ETON) has successfully closed an offering of 3,220,000 shares of common stock at $7.00 per share, raising approximately $22.5 million before expenses. This total includes 420,000 shares from the underwriter's overallotment option. The net proceeds are earmarked for general corporate purposes such as research and development, capital expenditures, and working capital needs. National Securities Corporation managed the offering. Please refer to the SEC for the final prospectus details.
Eton Pharmaceuticals (Nasdaq: ETON) announced that the FDA has accepted its new drug application for zonisamide oral suspension, targeting partial seizures in epilepsy patients. The application has a PDUFA date set for May 29, 2021. This marks a significant step for Eton as zonisamide is one of three neurology-focused liquid products they expect to launch in 2021. Eton currently has three FDA-approved products and six in late-stage development, reflecting its commitment to innovating treatments for rare pediatric diseases.
Eton Pharmaceuticals, Inc (Nasdaq: ETON) announced the pricing of an underwritten public offering of 2,800,000 shares at $7.00 per share, totaling gross proceeds of $19.6 million. An additional 420,000 shares may be purchased by underwriters, potentially increasing proceeds to $22.5 million. The offering is set to close on or about October 16, 2020. Proceeds will be used for corporate purposes, including R&D and working capital. National Securities Corporation acts as the book-running manager. The shares are offered under an SEC registration statement.
Eton Pharmaceuticals, Inc. (Nasdaq: ETON) announced a public offering of its common stock, expected to price on or about October 14, 2020. Proceeds will primarily fund general corporate purposes, including R&D and working capital needs. The offering is managed by National Securities Corporation, a subsidiary of National Holdings. The shares are part of a previously filed registration statement with the SEC. Eton focuses on innovative treatments for rare pediatric diseases and has three FDA-approved products along with six in its late-stage pipeline.
Eton Pharmaceuticals, Inc. announced that the FDA has accepted its new drug application (NDA) for dehydrated alcohol injection, with a PDUFA date set for May 27, 2021. The drug, which is crucial for treating methanol poisoning, has received orphan drug designation, ensuring seven years of market exclusivity upon approval. The U.S. market for this injection is estimated to exceed $100 million annually, currently supplied by only one manufacturer. Eton focuses on developing innovative treatments for rare pediatric diseases and has multiple products in its late-stage pipeline.
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