Eton Pharmaceuticals, Inc. ETON
Eton Pharmaceuticals, Inc. (Nasdaq: ETON) is an endocrine/women's health drug developer. Its lead program, INCRELEX (mecasermin), is in Phase 1 for severe primary IGF-1 deficiency. 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.
Next further out: LIBERVANT (diazepam buccal film) — Eton anticipates commercial availability of LIBERVANT in April 2027, subject to final FDA approval. (April 2027). 1 catalyst on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| INCRELEX | IGF-1 deficiency | protein/peptide | Approved |
| ALKINDI SPRINKLE | adrenal insufficiency | small molecule | Approved |
| DESMODA (ET-600) | central diabetes insipidus | small molecule | Approved |
| IMPAVIDO | leishmaniasis | small molecule | Approved |
| ET-700 | rare disease | small molecule | Phase 1 |
| ET-800 | rare disease | small molecule | Pre-clinical |
| Zeneo hydrocortisone autoinjector | adrenal crisis | device-combination | Pre-clinical |
Recent results and decisions
- Oct 14, 2026submitted Type 9 NDA under FDA review to expand LIBERVANT label to ages 6-11 with PDUFA date of March 29, 2027.
A Type 9 New Drug Application (NDA) is under review with the U.S. FDA to add ages 6 to 11 to the product's label. The NDA has a Prescription Drug User Fee Act (PDUFA) target action date of March 29, 2027.
Filing - Oct 13, 2026n/a Eton acquires exclusive U.S. commercialization rights to LIBERVANT from Aquestive for $10 million upfront plus milestones up to $47.5 million.
The Company paid Aquestive an upfront license fee of $10.0 million.
Filing - Aug 5, 2026positive Licensor Auson Phase II/III (n=168): week-24 elimination or near-elimination in 56% (BID) and 42% (TID) vs 15% placebo.
In the study, 56% of patients applying ASN-001 twice daily and 42% of patients taking ASN-001 three times per day showed elimination or near-elimination of their infantile hemangiomas at week 24, compared with 15% in the placebo group.
Filing
1 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 1 endocrine/women's health companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.