Eton Pharmaceuticals, Inc. ETON
Eton Pharmaceuticals, Inc. (Nasdaq: ETON) is a specialty pharmaceutical company. Its next catalyst on record is LIBERVANT (diazepam buccal film): Type 9 NDA for LIBERVANT ages 6-11 expansion has PDUFA target action date of March 29, 2027. (March 29, 2027).
Upcoming catalysts
- March 29, 2027LIBERVANT (diazepam buccal film) — Type 9 NDA for LIBERVANT ages 6-11 expansion has PDUFA target action date of March 29, 2027.
The NDA has a Prescription Drug User Fee Act (PDUFA) target action date of March 29, 2027.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| INCRELEX | Growth failure | protein/peptide | Approved |
| HEMANGEOL | Infantile hemangiomas | small molecule | Approved |
| ALKINDI SPRINKLE | Adrenal insufficiency | small molecule | Approved |
| KHINDIVI | Adrenal insufficiency | small molecule | Approved |
| DESMODA | Not specified | unclear | Approved |
| GALZIN | Wilson's disease | small molecule | Approved |
| PKU GOLIKE | Phenylketonuria | unclear | Approved |
| IMPAVIDO | Leishmaniasis | small molecule | Approved |
| Carglumic Acid | N-acetylglutamate synthase deficiency | small molecule | Approved |
| Betaine Anhydrous | Homocystinuria | small molecule | Approved |
| Nitisinone | Hereditary tyrosinemia type 1 | small molecule | Approved |
| LIBERVANT | Not specified | unclear | Approved |
Recent results and decisions
- Nov 5, 2026accepted KHINDIVI label expansion Prior Approval Supplement accepted for review with May 28, 2027 PDUFA date to expand indicated age range to include children under five.
KHINDIVI label expansion Prior Approval Supplement (PAS) accepted for review and assigned May 28, 2027 PDUFA date.
Filing - Nov 5, 2026positive ET-700 proof-of-concept study completed showing substantially lower adverse event rate than GALZIN with 1 of 12 ET-700 participants versus 8 of 12 GALZIN participants experiencing treatment-related adverse events.
ET-700 demonstrated an adverse event rate substantially lower than GALZIN. Treatment-related adverse events occurred in 1 of 12 ET-700 participants compared with 8 of 12 GALZIN participants.
Filing - Nov 5, 2026started Research IND submitted to FDA for Phase 2 study evaluating INCRELEX (mecasermin) in epileptic spasms, with trial anticipated to begin enrolling in first quarter 2027.
A research Investigational New Drug (IND) application has been submitted to the FDA for a Phase 2 study evaluating INCRELEX in epileptic spasms. The trial is anticipated to begin enrolling and dosing patients in the first quarter of 2027.
Filing
6 more on record.
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