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, 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.
Eton Pharmaceuticals has submitted a new drug application (NDA) for its topiramate oral solution to the FDA. This formulation addresses the unmet need for a pediatric-friendly liquid version of topiramate, targeting partial-onset seizures and migraines. It is anticipated to be the first FDA-approved liquid formulation of topiramate, which could tap into a market exceeding $800 million annually. Eton aims for approval and launch of this candidate in 2021, marking its third neurology-focused product submission.
Eton Pharmaceuticals announced FDA approval for ALKINDI SPRINKLE, the first granular hydrocortisone formulation for pediatric adrenocortical insufficiency. Designed for children under 17, it provides flexible dosing with strengths of 0.5mg, 1mg, 2mg, and 5mg, addressing prior dosing challenges. Expected availability is in Q4 2020, aiding an estimated 5,000 to 11,000 affected children in the U.S. This product allows caregivers to avoid splitting tablets, enhancing treatment precision and safety.
