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Eton Pharmaceuticals Stock Price, News & Analysis

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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.

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Eton Pharmaceuticals, Inc. (Nasdaq: ETON) has received a Complete Response Letter (CRL) from the FDA concerning its New Drug Application for dehydrated alcohol injection used in treating methanol poisoning. The FDA's review concluded the application cannot be approved in its current form. A Pre-Approval Inspection of the European manufacturer is pending due to COVID-related travel restrictions. Eton anticipates addressing all FDA queries in a forthcoming response.

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Eton Pharmaceuticals, Inc. (Nasdaq: ETON) reported Q1 2021 revenue of $11.9 million, a significant increase from $0.1 million in the prior year, marking its first profitable quarter with operating income of $5.4 million and EPS of $0.19. The company has three commercial products generating revenue and anticipates additional launches from four upcoming PDUFA dates in the next three months. Eton's strong cash position of $25.1 million supports its growth strategy, including the recent successful launch of Alaway Preservative Free and ongoing development of pipeline products.

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Eton Pharmaceuticals (Nasdaq: ETON) will release its first quarter 2021 financial and operating results on May 13, 2021. A conference call and audio webcast to discuss these results will be held at 4:30 p.m. ET. Investors can access the live webcast on the company’s investor relations website and listen by dialing specific numbers for domestic and international calls. Eton develops treatments for rare diseases and owns or earns royalties from three FDA-approved products while advancing six additional products submitted to the FDA.

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Eton Pharmaceuticals announced the appointment of Jenn Adams to its board of directors, effective March 17, 2021. Ms. Adams brings substantial experience in the pharmaceutical industry, having previously served as CEO of August Bioservices and in senior roles at AmerisourceBergen and Baxter Healthcare. She replaces Mark Baum, who resigned to focus on his role at Harrow Health. Eton's CEO, Sean Brynjelsen, expressed confidence in Adams' ability to support product launches and commercial growth. Eton focuses on developing treatments for rare diseases and has multiple FDA-approved products.

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Eton Pharmaceuticals (ETON) reported its financial results for Q4 and full year 2020, revealing a significant net loss of $28.0 million, up from $18.3 million in 2019. The company's revenue was $0.1 million for Q4 2020, largely due to the late launch of ALKINDI SPRINKLE. Notable milestones included the launch of ALKINDI SPRINKLE and Alaway Preservative-Free, with an expectation of over $25 million in revenue for 2021. Eton completed a sale of its neurology portfolio for up to $45 million, enhancing its profitability outlook. However, ongoing high R&D and SG&A expenses remain concerning.

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Eton Pharmaceuticals, Inc (Nasdaq: ETON) will announce its fourth quarter and full year 2020 financial results on March 16, 2021, at 4:30 p.m. ET. Management will host a conference call and audio webcast to discuss these outcomes and provide a business update. Interested parties can access the live webcast on Eton's investor section of its website. Eton focuses on developing innovative treatments for rare pediatric diseases and currently has three FDA-approved products and six additional products submitted for FDA review.

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Eton Pharmaceuticals, Inc. (Nasdaq: ETON), a company dedicated to innovative treatments for rare pediatric diseases, announced its participation in the 10th Annual SVB Leerink Global Healthcare Conference from February 24-26, 2021. Eton currently has three FDA-approved products, including ALKINDI® SPRINKLE, Biorphen®, and Alaway Preservative Free®, and has six additional products submitted to the FDA. The company emphasized that forward-looking statements regarding its business strategy and product development may be subject to risks and uncertainties.

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Eton Pharmaceuticals announced the sale of its neurology portfolio to Azurity Pharmaceuticals for up to $45 million, plus royalties on sales. The portfolio includes drug candidates ET-105, ET-104, and ET-101, which are under FDA review. CEO Sean Brynjelsen highlighted that this deal allows Eton to concentrate on its orphan drug business and improve profitability by avoiding sales force investments. Eton will receive $15 million at closing, with additional payments tied to regulatory and sales milestones.

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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.

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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.

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FAQ

What is the current stock price of Eton Pharmaceuticals (ETON)?

The current stock price of Eton Pharmaceuticals (ETON) is $18.34 as of September 19, 2025.

What is the market cap of Eton Pharmaceuticals (ETON)?

The market cap of Eton Pharmaceuticals (ETON) is approximately 495.1M.
Eton Pharmaceuticals

Nasdaq:ETON

ETON Rankings

ETON Stock Data

495.05M
25.66M
4.39%
62.57%
13.76%
Drug Manufacturers - Specialty & Generic
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