HBS-102 PDUFA date: FDA decision expected January 18, 2027
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.
Source: sec.gov · Data checked November 12, 2026. How we check dates. Confirm dates against the company's or the FDA's announcement before acting.
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Questions about this FDA decision
- When is the PDUFA date for HBS-102?
- The FDA's PDUFA target action date for HBS-102 is January 18, 2027. The FDA can act before that date, and the review can be extended.
- What is HBS-102 being reviewed for?
- The application under FDA review covers narcolepsy.
- Which company is developing HBS-102?
- Harmony Biosciences Holdings, Inc. (HRMY).
- What can happen on a PDUFA date?
- The FDA approves the application, issues a complete response letter (CRL) listing what must be fixed before approval, or extends the review (typically by three months after a major amendment).