Key Takeaways
- The FDA sent a refuse-to-file letter to Harmony Biosciences for its sNDA seeking approval for Wakix in idiopathic hypersomnia, likely delaying launch to 2028 or later.
Harmony Biosciences plans to accelerate Phase III development of a high-dose pitolisant formulation (pitolisant HD) in idiopathic hypersomnia (IH) after...
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Pink Sheet for daily insights
- Start your 7-day free trial
- Explore trusted news, analysis, and insights
- Access comprehensive global coverage
- Enjoy instant access – no credit card required
Already a subscriber?