Eton Pharmaceuticals announced that the U.S. Food and Drug Administration approved its oral liquid therapy, DESMODA™ (desmopressin acetate), for the treatment of central diabetes insipidus on February 25, 2026.
DESMODA is the first and only FDA‑approved desmopressin oral solution, giving clinicians and patients a precise, individualized dosing option that eliminates the need for tablet splitting or crushing.
Central diabetes insipidus affects more than 13,000 U.S. patients, including 3,000‑4,000 pediatric cases, and the new formulation addresses a significant unmet need by enabling fine‑tuned dosing across all age groups.
Eton’s recent financial performance underscores the commercial potential of DESMODA: the company reported a 117% year‑over‑year increase in net revenue to $48.3 million for the trailing twelve months ending in Q1 2025, and Q3 2025 earnings saw revenue of $22.46 million, beating estimates while EPS missed expectations.
The announcement was well received by investors, reflecting confidence in the product’s commercial potential and its projected peak annual sales of $30‑$50 million.
CEO Sean Brynjelsen said, "Desmoda represents one of the most important product launches in Eton's history. It builds on our strategy of delivering differentiated therapies to rare endocrine patients. By leveraging our existing pediatric endocrinology platform, we believe Desmoda has the potential to become a foundational therapy in this category." He added, "Central diabetes insipidus requires careful, individualized management, where dosing precision and flexibility truly matter. Having a liquid formulation of desmopressin has the potential to meaningfully support how we initiate and manage therapy. It's encouraging to see innovation that directly addresses real‑world challenges faced by clinicians and families and gives greater confidence when tailoring treatment across age groups."
Eton will launch DESMODA on March 9, 2026, exclusively through specialty pharmacy Anovo, and will leverage its existing commercial network and patient‑support program, Eton Cares, to accelerate market penetration.
The approval positions Eton as the sole provider of an oral desmopressin solution, giving it a competitive edge in a niche market and reinforcing its strategy of patient‑centric formulations that improve adherence and outcomes.
The new product expands Eton’s rare‑disease portfolio and supports its broader pipeline, which includes late‑stage candidates such as ET‑400 (Khindivi) and Amglidia, and a recently licensed ultra‑rare disease candidate slated for a mid‑2026 launch.
revised_sentiment_rating":4} }
The content on EveryTicker is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.