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ETON biotech catalysts & pipeline

ETON PHARMACEUTICALS INC · Data as of 2026-09-08

Upcoming catalysts

ET-700 — Topline data

H2 2026

Topline study results are expected in the second half of 2026, and if positive, would lead to a pivotal clinical study in early 2027.
Source filing

KHINDIVI (hydrocortisone) — NDA/BLA submission

Q3 2026

Eton intends to file the supplement in the third quarter of 2026, which could provide for a potential approval in the second quarter of 2027.
Source filing

AMGLIDIA® — NDA/BLA submission

Late 2026

The Company plans to initiate a bioavailability study for the product later this month and remains on track to submit an NDA by the end of 2026, allowing for potential approval and launch in 2027.
Source filing

KHINDIVI (hydrocortisone) — Regulatory decision

Q2 2027

Eton intends to file the supplement in the third quarter of 2026, which could provide for a potential approval in the second quarter of 2027.
Source filing

ASN-001 — NDA/BLA submission

H2 2027

The Company plans to initiate a bioavailability study and anticipates a New Drug Application ("NDA") submission upon the study's completion in the second half of 2027.
Source filing

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