Eton Pharmaceuticals Announces FDA Acceptance of New Drug Application for ET-600 (Desmopressin Oral Solution)
Eton Pharmaceuticals (Nasdaq: ETON) announced that the FDA has accepted its New Drug Application (NDA) for ET-600, a proprietary desmopressin oral solution. The FDA has assigned a PDUFA target action date of February 25, 2026 for the review.
ET-600 aims to address unmet needs in pediatric endocrinology by providing a liquid formulation alternative to fractional tablets and compounded suspensions. The product has patent protection through 2044 and, if approved, would be the only oral liquid option available in the market. Eton is preparing for a potential commercial launch in Q1 2026.
Eton Pharmaceuticals (Nasdaq: ETON) ha annunciato che la FDA ha accettato la sua Domanda di Nuovo Farmaco (NDA) per ET-600, una soluzione orale proprietaria di desmopressina. La FDA ha fissato una data obiettivo PDUFA per il 25 febbraio 2026 per la revisione.
ET-600 mira a soddisfare le esigenze insoddisfatte in endocrinologia pediatrica offrendo un'alternativa in forma liquida alle compresse frazionate e alle sospensioni magistrali. Il prodotto 猫 protetto da brevetto fino al 2044 e, se approvato, sarebbe l'unica opzione orale liquida disponibile sul mercato. Eton si sta preparando per un possibile lancio commerciale nel primo trimestre del 2026.
Eton Pharmaceuticals (Nasdaq: ETON) anunci贸 que la FDA ha aceptado su Solicitud de Nuevo F谩rmaco (NDA) para ET-600, una soluci贸n oral propietaria de desmopresina. La FDA ha asignado una fecha objetivo PDUFA para el 25 de febrero de 2026 para la revisi贸n.
ET-600 busca cubrir necesidades no satisfechas en endocrinolog铆a pedi谩trica ofreciendo una alternativa en soluci贸n l铆quida a las tabletas fraccionadas y suspensiones magistrales. El producto cuenta con protecci贸n de patente hasta 2044 y, si se aprueba, ser铆a la 煤nica opci贸n l铆quida oral disponible en el mercado. Eton se est谩 preparando para un posible lanzamiento comercial en el primer trimestre de 2026.
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ET-600鞚� 攵勴暊 鞝曥牅鞕� 臁办牅 順勴儊鞎§棎 雽�頃� 鞎§儊 鞝滍槙 雽�鞎堨潉 鞝滉车頃橃棳 靻岇晞 雮措秳牍勴暀 攵勳暭鞚� 氙胳订臁� 靾橃殧毳� 頃搓舶頃橂姅 瓴冹潉 氇╉憸搿� 頃╇媹雼�. 鞚� 鞝滍拡鞚� 2044雲勱箤歆� 韸鬼棃 氤错樃毳� 氚涭溂氅�, 鞀轨澑霅� 瓴届毎 鞁滌灔鞐愳劀 鞙犾澕頃� 瓴疥惮鞖� 鞎§儊 鞓奠厴鞚� 霅� 瓴冹瀰雼堧嫟. Eton鞚� 2026雲� 1攵勱赴鞐� 鞛犾灛鞝侅澑 靸侅梾 於滌嫓毳� 欷�牍勴晿瓿� 鞛堨姷雼堧嫟.
Eton Pharmaceuticals (Nasdaq : ETON) a annonc茅 que la FDA a accept茅 sa demande de nouveau m茅dicament (NDA) pour ET-600, une solution orale propri茅taire de desmopressine. La FDA a fix茅 une date cible PDUFA au 25 f茅vrier 2026 pour l'examen.
ET-600 vise 脿 r茅pondre aux besoins non satisfaits en endocrinologie p茅diatrique en proposant une alternative en solution liquide aux comprim茅s fractionn茅s et aux suspensions pr茅par茅es. Le produit b茅n茅ficie d'une protection par brevet jusqu'en 2044 et, s'il est approuv茅, serait la seule option liquide orale disponible sur le march茅. Eton se pr茅pare 脿 un lancement commercial potentiel au 1er trimestre 2026.
Eton Pharmaceuticals (Nasdaq: ETON) gab bekannt, dass die FDA seinen Antrag auf Zulassung eines neuen Medikaments (NDA) f眉r ET-600, eine propriet盲re orale Desmopressin-L枚sung, akzeptiert hat. Die FDA hat ein PDUFA-Zieldatum f眉r den 25. Februar 2026 f眉r die 脺berpr眉fung festgelegt.
ET-600 zielt darauf ab, ungedeckte Bed眉rfnisse in der p盲diatrischen Endokrinologie zu adressieren, indem es eine fl眉ssige Darreichungsform als Alternative zu geteilten Tabletten und hergestellten Suspensionen bietet. Das Produkt ist bis 2044 辫补迟别苍迟驳别蝉肠丑眉迟锄迟 und w盲re, falls zugelassen, die einzige orale Fl眉ssigoption auf dem Markt. Eton bereitet sich auf eine m枚gliche Markteinf眉hrung im ersten Quartal 2026 vor.
- Product has extensive patent protection through 2044
- Would be the only FDA-approved oral liquid option in the market
- Addresses significant unmet need in pediatric endocrinology
- Near-term product launch opportunity in Q1 2026
- Long regulatory review period with PDUFA date set for February 2026
- No guarantee of FDA approval
- NDA assigned a Target Action Date of February 25, 2026 -
- Product has patent protection through 2044 -
DEER PARK, Ill., July 08, 2025 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (鈥淓ton鈥� or the 鈥淐ompany鈥�) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced the Company鈥檚 New Drug Application (NDA) for ET-600, a proprietary patented formulation of desmopressin oral solution, has been accepted for review by the U.S. Food and Drug Administration (FDA) and has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of February 25, 2026.
鈥淲e are thrilled to be one step closer to bringing ET-600 to patients and addressing another significant unmet need within the pediatric endocrinology community. Currently, caregivers are often forced to cut fractional tablets or use unapproved liquid suspensions from compounding pharmacies to accommodate the precise, titratable doses required to treat pediatric patients. If approved, ET-600 is expected to be the only oral liquid option on the market, providing a much-needed avenue for delivering accurate doses for children,鈥� said Sean Brynjelsen, CEO of Eton Pharmaceuticals. 鈥淓T-600 represents yet another high-value near term product launch opportunity for Eton and our team has already initiated commercial preparation activities in anticipation of a potential launch in the first quarter of 2026.鈥�
About ET-600
ET-600 is a proprietary formulation of desmopressin oral solution developed for the treatment of central diabetes insipidius, also known as arginine vasopressin deficiency (AVP-D). The company has been issued a patent for ET-600鈥檚 formulation that extends to 2044 and has an additional patent application under review by the United States Patent and Trademark Office. AVP-D is estimated to impact approximately 3,000 pediatric patients in the United States.
About Eton Pharmaceuticals
Eton is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases. The Company currently has eight commercial rare disease products: KHINDIVI鈩�, INCRELEX庐, ALKINDI SPRINKLE庐, GALZIN庐, PKU GOLIKE庐, Carglumic Acid, Betaine Anhydrous, and Nitisinone. The Company has five additional product candidates in late-stage development: ET-600, Amglidia庐, ET-700, ET-800 and ZENEO庐 hydrocortisone autoinjector. For more information, please visit our website at www.etonpharma.com.
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are 鈥渇orward-looking statements鈥� within the meaning of the Private Securities Litigation Reform Act of 1995, including statements associated with the expected ability of Eton to undertake certain activities and accomplish certain goals and objectives. These statements include but are not limited to statements regarding Eton鈥檚 business strategy, Eton鈥檚 plans to develop and commercialize its product candidates, the safety and efficacy of Eton鈥檚 product candidates, Eton鈥檚 plans and expected timing with respect to regulatory filings and approvals, and the size and growth potential of the markets for Eton鈥檚 product candidates. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as 鈥渂elieves,鈥� 鈥渁nticipates,鈥� 鈥減lans,鈥� 鈥渆xpects,鈥� 鈥渋ntends,鈥� 鈥渨ill,鈥� 鈥済oal,鈥� 鈥減otential鈥� and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Eton鈥檚 current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. These and other risks concerning Eton鈥檚 development programs and financial position are described in additional detail in Eton鈥檚 filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Eton undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Investor Relations:
Lisa M. Wilson, In-Site Communications, Inc.
T: 212-452-2793
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Source: Eton Pharmaceuticals.
FAQ
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