Intel stock spikes after report of possible US government stake
DEER PARK, Ill. - Eton Pharmaceuticals, Inc. (NASDAQ:ETON), a specialty pharmaceutical company with a market capitalization of $386 million and an impressive 323% return over the past year, announced Tuesday that the U.S. Food and Drug Administration has accepted its New Drug Application for ET-600, a proprietary formulation of desmopressin oral solution. The FDA assigned a target action date of February 25, 2026, under the Prescription Drug User Fee Act. According to InvestingPro analysis, the company appears undervalued based on its Fair Value estimates.
ET-600 is being developed to treat central diabetes insipidus, also known as arginine vasopressin deficiency (AVP-D), a condition that affects approximately 3,000 pediatric patients in the United States. The company has demonstrated strong revenue growth of 41% in the last twelve months, with analysts expecting continued sales growth this year, according to InvestingPro data.
If approved, ET-600 would become the only oral liquid option available for this condition. Currently, caregivers often must cut tablets or use compounded liquid suspensions to provide appropriate doses for pediatric patients.
"We are thrilled to be one step closer to bringing ET-600 to patients and addressing another significant unmet need within the pediatric endocrinology community," said Sean Brynjelsen, CEO of Eton Pharmaceuticals.
The company has secured patent protection for ET-600’s formulation extending to 2044, with an additional patent application under review by the United States Patent and Trademark Office.
Eton has begun commercial preparation activities in anticipation of a potential launch in the first quarter of 2026, according to the company’s press release statement.
Eton Pharmaceuticals focuses on developing and commercializing treatments for rare diseases and currently has eight commercial rare disease products in its portfolio, with five additional product candidates in late-stage development. While currently operating at a loss, analysts tracked by InvestingPro expect the company to achieve profitability this year, with price targets ranging from $26 to $35 per share. For deeper insights into Eton’s financial health and growth prospects, investors can access the comprehensive Pro Research Report, available exclusively to InvestingPro subscribers.
In other recent news, Eton Pharmaceuticals reported a strong first quarter for 2025, with revenue reaching $17.3 million, a 117% increase from the previous year. This substantial growth was driven by robust product sales and licensing revenue, despite the company posting a net loss of $1.6 million. Eton Pharmaceuticals also announced that the U.S. Food and Drug Administration (FDA) approved KHINDIVI, a hydrocortisone oral solution for pediatric patients, marking the first FDA-approved oral solution for this purpose. The approval of KHINDIVI is expected to complement Eton’s existing product portfolio, with anticipated peak sales, in combination with ALKINDI SPRINKLE, surpassing $50 million annually.
Additionally, Eton Pharmaceuticals is set to join the Russell 2000 and 3000 Indexes, which could enhance its visibility among institutional investors. H.C. Wainwright increased its price target for Eton Pharmaceuticals to $35, maintaining a Buy rating, reflecting confidence in the company’s commercial execution capabilities. The analyst firm projects Eton’s total revenue to reach $74 million in 2025, a significant increase from the $39 million reported in 2024. Eton Pharmaceuticals’ CEO, Sean Brynjelsen, expressed optimism about the company’s growth trajectory, noting a strong cash position with $17.4 million on hand.
The company also highlighted the relaunch of Increlex and GALZIN, with the potential to make 2025 a year of revenue inflection. Eton Pharmaceuticals is targeting a $100 million revenue run rate in the near term, supported by multiple product launches planned between 2025 and 2027. These developments underscore Eton Pharmaceuticals’ strategic focus on expanding its product offerings and strengthening its position in the rare disease market.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.