Eton Pharmaceuticals, INC 8-K filings
NASDAQ
8-K: Eton Pharmaceuticals Secures New U.S. Patent for ET-600, Expanding Intellectual Property Portfolio
Eton Pharmaceuticals receives a new U.S. patent for its ET-600 product, a proprietary desmopressin oral solution, providing patent protection through 2044.
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Eton Pharmaceuticals reports that the FDA has extended the PDUFA goal date for ET-400 to May 28, 2025, due to the need for additional review time.
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Eton Pharmaceuticals has acquired Galzin, an FDA-approved treatment for Wilson Disease, from Teva Pharmaceuticals, further solidifying its commitment to rare disease therapies.
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8-K: Eton Pharmaceuticals Completes Acquisition of Increlex, Bolstering Pediatric Endocrinology Portfolio
Eton Pharmaceuticals has finalized the acquisition of Increlex, a biologic treatment for severe primary insulin-like growth factor 1 deficiency, from Ipsen S.A., expanding its rare disease portfolio.
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Eton Pharmaceuticals reports successful clinical trial results for PKU GOLIKE, demonstrating improved metabolic control in PKU patients during fasting periods.
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Eton Pharmaceuticals has entered into a securities purchase agreement to sell 583,334 shares of common stock at $12.00 per share, raising approximately $7 million for potential acquisitions.
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Eton Pharmaceuticals has appointed Ipek Erdogan-Trinkaus as its new Chief Commercial Officer, effective immediately.
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Eton Pharmaceuticals has secured the U.S. rights to Amglidia, a European-approved treatment for neonatal diabetes, with plans to file a New Drug Application (NDA) in 2026.
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Eton Pharmaceuticals reports its first ever positive GAAP net income quarter, driven by a 40% year-over-year increase in product sales and a 15th consecutive quarter of sequential growth.
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Eton Pharmaceuticals has been granted a second patent for its ET-400 liquid hydrocortisone formulation, further strengthening its intellectual property protection.
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Eton Pharmaceuticals has agreed to acquire Increlex, a treatment for severe primary insulin-like growth factor 1 deficiency, from Ipsen for $22.5 million plus additional payments and inventory purchases.
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Eton Pharmaceuticals announced a 40% year-over-year increase in product sales and royalty revenue for the second quarter of 2024, alongside significant pipeline advancements.
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Eton Pharmaceuticals will hold advisory Say-on-Pay votes every three years, following a shareholder vote favoring annual votes.
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Eton Pharmaceuticals announced that the FDA has accepted its New Drug Application for ET-400, a proprietary hydrocortisone oral solution, with a target action date set for February 28, 2025.
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Eton Pharmaceuticals has changed its independent registered public accounting firm from KMJ Corbin & Company LLP to Crowe LLP, effective June 14, 2024, following KMJ's resignation due to its partners and staff joining Crowe.
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Eton Pharmaceuticals held its 2024 Annual Meeting, where stockholders elected directors, approved executive compensation on an advisory basis, and ratified the appointment of its independent auditor.
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Eton Pharmaceuticals reported a 50% year-over-year revenue increase in the first quarter of 2024, fueled by strong sales of ALKINDI SPRINKLE and Carglumic Acid, and strategic acquisitions.
NASDAQ
8-K: Eton Pharmaceuticals Submits New Drug Application to FDA for ET-400 Hydrocortisone Oral Solution
Eton Pharmaceuticals has submitted a New Drug Application to the FDA for its proprietary hydrocortisone oral solution, ET-400, with potential approval anticipated in Q1 2025.
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Eton Pharmaceuticals' planned $13.1 million capital raise and $21.9 million credit facility expansion were canceled after the company was not the winning bidder in an auction for certain assets of Eiger BioPharmaceuticals.
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Eton Pharmaceuticals has acquired the U.S. rights to PKU GOLIKE, a medical formula for phenylketonuria, from Relief Therapeutics for $2.2 million upfront and potential milestone payments.
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Eton Pharmaceuticals announced a 109% increase in Q4 revenue compared to the previous year, marking the twelfth consecutive quarter of sequential product sales growth, alongside positive developments in their drug pipeline.
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Eton Pharmaceuticals has been granted a U.S. patent for its proprietary oral liquid hydrocortisone formulation, ET-400, with an expiration date in 2043.
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Eton Pharmaceuticals has announced the commercial availability of Nitisinone Capsules, a treatment for hereditary tyrosinemia type 1 (HT-1), with a patient support program offering $0 co-pays for eligible patients.