1. HRMY received an FDA Refusal to File for pitolisant therapy. 2. Net revenue guidance for 2025 remains unchanged at $820-$860 million.
The FDA RTF letter signals potential delays in product approval, impacting investor sentiment. Similar past instances, like other drug delays, typically led to stock declines.
The FDA's decision directly impacts HRMY’s product pipeline, crucial for future growth. Investor reactions to FDA actions can significantly sway stock prices.
This setback is likely to affect HRMY's stock performance in the immediate future. Historical cases of RTF letters often result in near-term stock volatility.