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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 (Nasdaq: ETON), a company focused on developing and commercializing treatments for rare diseases, has announced it will report its second quarter 2024 financial results on Thursday, August 8, 2024. The company will host a conference call and live audio webcast at 4:30 p.m. ET (3:30 p.m. CT) to discuss the results.
Management will take live questions from call participants and answer emailed questions from investors. Investors can email their questions to investorrelations@etonpharma.com. The live webcast will be accessible on Eton's website, with an archived version available for 30 days after the event.
Eton Pharmaceuticals (Nasdaq: ETON) announced FDA acceptance of its New Drug Application (NDA) for ET-400, a proprietary patented formulation of hydrocortisone oral solution. The FDA assigned a PDUFA target action date of February 28, 2025. ET-400 is a room temperature stable formulation with patent protection through 2043.
CEO Sean Brynjelsen stated that ET-400's approval could allow Eton to capture a larger share of the oral hydrocortisone market. Combined with ALKINDI SPRINKLE®, the company anticipates peak sales exceeding $50 million annually. Eton is preparing for a potential launch in early 2025, pending FDA approval.
Eton Pharmaceuticals, Inc reported robust financial results for Q1 2024, with revenue of $8.0 million, a 50% increase over Q1 2023. The company achieved its 13th consecutive quarter of sequential product sales growth, acquired PKU GOLIKE®, launched Nitisinone, and submitted an NDA for product candidate ET-400. Eton anticipates strong growth in 2024, driven by existing products and new additions, positioning itself for a potential successful launch of ET-400 in early 2025.
Eton Pharmaceuticals, Inc (Nasdaq: ETON) will present at the Citizens JMP Life Sciences Conference in New York on May 13, 2024. Sean Brynjelsen, CEO, and James Gruber, CFO, will participate. For meeting requests, contact Citizens JMP.
Eton Pharmaceuticals submitted a New Drug Application (NDA) for ET-400, a hydrocortisone oral solution with patent protection through 2043. The company expects potential approval by Q1 2025, aiming for combined peak sales of over $50 million annually.
Eton Pharmaceuticals, Inc. will report its first quarter 2024 financial results on May 9, 2024. The company focuses on developing treatments for rare diseases. A conference call and webcast will discuss the results at 4:30 p.m. ET on the same day. Investors can email questions or access the webcast on Eton's website.
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