Welcome to our dedicated page for Eton Pharmaceuticals news (Ticker: ETON), a resource for investors and traders seeking the latest updates and insights on Eton Pharmaceuticals stock.
ETON Pharmaceuticals (ETON) is a specialty pharmaceutical leader focused on rare disease treatments through innovative FDA pathways. This page aggregates all verified company announcements, regulatory updates, and therapeutic developments.
Access real-time updates on ETON's 505(b)(2) pipeline progress, pediatric endocrinology treatments, and strategic partnerships. Investors and healthcare professionals will find essential information on:
- FDA approval milestones
- Clinical trial results
- Intellectual property updates
- Commercialization partnerships
- Financial performance highlights
Bookmark this page for streamlined tracking of ETON's advancements in metabolic disorder treatments and rare disease therapies. Our curated news collection supports informed decision-making for stakeholders across the healthcare ecosystem.
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.
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