High materiality8/10
Harmony Biosciences Stock Falls On FDA Setback For Pitolisant In Sleeping Disorder
Why it may matterVerify against the original reporting
The FDA's RTF may hinder HRMY's growth prospects, similar to past drug rejections.
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What happened, with direct paths to the underlying reporting
HRMY received FDA's Refusal to File for pitolisant in IH. 2025 revenue guidance of $820-$860 million remains intact. Phase 3 trial for Pitolisant HD is planned for Q4 2025. Wakix sales rose, with net revenue increasing to $201 million. Analyst maintains 'Buy' but lowers price target from $52 to $50.
- HRMY received FDA's Refusal to File for pitolisant in IH.
- 2025 revenue guidance of $820-$860 million remains intact.
- Phase 3 trial for Pitolisant HD is planned for Q4 2025.
- Wakix sales rose, with net revenue increasing to $201 million.
- Analyst maintains 'Buy' but lowers price target from $52 to $50.
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