Eton Pharmaceuticals nears NDA submission for new drug

DEER PARK, Ill. - Eton Pharmaceuticals, Inc. (NASDAQ:ETON), a $377 million market cap pharmaceutical company whose stock has surged over 227% in the past year, has announced the successful completion of a pivotal bioequivalence study for ET-600, its proprietary oral solution of desmopressin, aimed at treating central diabetes insipidus. The study, involving 75 healthy adults, showed that ET-600 is pharmacokinetically equivalent to the FDA-approved reference product. According to InvestingPro analysis, the company maintains a moderate debt level with strong price momentum.

Eton, which specializes in developing treatments for rare diseases and generated $34.68 million in revenue over the last twelve months, expects to submit a New Drug Application (NDA) to the FDA in April 2025. Approval of ET-600 would mark the introduction of the only FDA-approved oral liquid formulation of desmopressin. This development is particularly significant for the pediatric endocrinology community, where there is a need for precise and adjustable dosing of desmopressin, especially for the estimated 3,000 pediatric patients in the U.S. with central diabetes insipidus. Analysts maintain a bullish outlook, with price targets ranging from $21 to $33.

The company has already been granted a patent for ET-600’s formulation, which extends to 2044, and has another patent application under review. Eton’s CEO, Sean Brynjelsen, expressed optimism about the drug’s progress and the company’s preparation for a potential product launch in the first quarter of 2026. For detailed analysis of Eton’s financial health and growth prospects, investors can access comprehensive research reports through InvestingPro, which provides exclusive insights on over 1,400 US stocks.

Eton Pharmaceuticals currently markets seven rare disease products and has four additional product candidates in late-stage development. The company’s portfolio includes treatments for conditions such as growth failure in children and metabolic disorders.

The press release also contained forward-looking statements regarding Eton’s business strategy and product development, which are subject to risks and uncertainties that could cause actual results to differ materially. These statements are based on current expectations and assumptions, and Eton does not undertake any obligation to update them.

The information reported here is based on a press release statement from Eton Pharmaceuticals.

In other recent news, Eton Pharmaceuticals has announced the launch of Galzin, an FDA-approved treatment for Wilson disease, now available through Optime Care. This development is part of Eton’s strategy to enhance patient access to rare disease treatments, supported by the Eton Cares patient support program. In addition, H.C. Wainwright has adjusted its price target for Eton Pharmaceuticals, lowering it to $33 from $37, while maintaining a Buy rating. The firm notes Eton’s consistent revenue growth and projects a substantial increase in revenue to $102.7 million by 2025, driven by recent product acquisitions and pipeline developments.

B.Riley has also initiated coverage on Eton Pharmaceuticals with a Buy rating and a 12-month price target of $21, citing optimism around products like Increlex and ET-400. The firm suggests that Eton may reach a revenue inflection point in 2025, potentially leading to profitability. Furthermore, H.C. Wainwright has revised its outlook on Eton, increasing the price target to $17, following the acquisition of Galzin from TEVA Pharmaceuticals. Eton plans to begin U.S. commercialization of Galzin in early 2025, with expectations that it will contribute to long-term growth.

Analysts from H.C. Wainwright estimate that Galzin could generate $0.9 million in revenue in 2025, with growth to $5.1 million by 2030. These recent developments highlight Eton Pharmaceuticals’ ongoing efforts to expand its portfolio and enhance market presence in the rare disease treatment sector.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.