Biotech stocks are often at the mercy of several catalysts – most of which are make-or-break events.  

Benzinga’s FDA calendar is a user-friendly, dynamically updated investment tool that is a ‘must-have’ for those looking to capitalize on the volatility that is typical of trading biotech stocks.

The calendar lists all key catalysts that can materially impact stocks, including:

  • PDUFA dates, or in other words FDA decision dates
  • Filing schedules for regulatory applications such as new drug application, or NDA, supplemental NDA, Biologic License Application, or BLA, supplemental BLA, Premarket Approval Application, or Premarket Notification 510(k), etc.
  • FDA decisions (approvals/complete response letter/delay)
  • According to special statuses for treatment options, including orphan drug designation, rare disease designation, accelerated approval, priority review etc.
  • FDA’s Advisory Committee, or Adcom, meetings
  • Review meetings with FDA (pre-investigational new drug application meetings, end-of-phase meetings, Type A, Type B and Type C meetings)
  • Decisions by overseas regulatory agencies
  • Clinical data readouts
  • Presentation of data at various scientific conferences

FDA events are important for both long term and short term investors. Announcements can be displayed in calendar form, listed within company detail pages and/or used as push notifications for user engagement.

Please refer to our documentation for further information – if you’d like to discuss with our team, please email