Eton Pharmaceuticals Inc. (ETON) announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for ET-400, a proprietary patented formulation of hydrocortisone oral solution. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of February 28, 2025.
If approved, ET-400 is expected to significantly increase Eton's share of the oral hydrocortisone market. Combined with ALKINDI SPRINKLE, the company anticipates achieving peak annual sales of over $50 million. Eton is currently preparing for a potential product launch in early 2025 and looks forward to continued collaboration with the FDA.
ET-400 is a unique formulation of oral hydrocortisone solution that remains stable at room temperature. A related patent has been granted by the U.S. Patent and Trademark Office, which will remain in effect until 2043, with additional patent applications under review.
Eton Pharmaceuticals currently markets five rare disease products: ALKINDI SPRINKLE, PKU GOLIKE, Carglumic Acid, Betaine Anhydrous, and Nitisinone. The company has three additional candidates in late-stage development: ET-400, ET-600, and the ZENEO hydrocortisone autoinjector.
On Monday, ETON closed regular trading at $3.34, down $0.07 or 2.05%. However, in after-hours trading, the stock surged, gaining $0.33 or 9.88%.
