Vanda Pharmaceuticals Receives Complete Response Letter From FDA As Part Of Ongoing Review Of sNDA For HETLIOZ (Tasimelteon) In Insomnia Treatment Characterized By Difficulties With Sleep Initiation
Portfolio Pulse from Benzinga Newsdesk
Vanda Pharmaceuticals has received a Complete Response Letter from the FDA regarding its supplemental New Drug Application (sNDA) for HETLIOZ (Tasimelteon) aimed at treating insomnia characterized by difficulties with sleep initiation. This letter is part of the ongoing review process.
March 06, 2024 | 12:03 pm
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Vanda Pharmaceuticals' receipt of a Complete Response Letter from the FDA for HETLIOZ may delay its market entry for treating specific insomnia, impacting investor sentiment.
Receiving a Complete Response Letter typically indicates that the FDA requires more information or has concerns that need to be addressed before approval. This can lead to delays in drug approval and market entry, which may negatively impact investor sentiment and the company's stock price in the short term.
CONFIDENCE 85
IMPORTANCE 90
RELEVANCE 100