Upcoming FDA decision · January 18, 2027
HBS-102 PDUFA date: FDA decision expected January 18, 2027
157 days to goHarmony Biosciences Holdings, Inc. (HRMY) →
The FDA is expected to decide on HBS-102 from Harmony Biosciences Holdings, Inc. in narcolepsy by the PDUFA target action date of January 18, 2027. For narcolepsy. NDA filing. Extracted from SEC filing: 8-K
A PDUFA date is the FDA's target deadline to complete its review of a drug application — approval, a complete response letter (CRL), or an extension are all possible. What is a PDUFA date? This page is research information, not financial advice.
January 18
Target action date
NDA
Stage
Detected
Date confidence
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FDA designations