Vanda Pharmaceuticals Announced Court Granted Vanda's Motion For Summary Judgment On Its Claim Against The FDA
Portfolio Pulse from Charles Gross
Vanda Pharmaceuticals Inc. (VNDA) won a court case against the FDA for unlawfully delaying a hearing on the approvability of its drug HETLIOZ® for jet lag disorder. The FDA failed to comply with statutory deadlines after Vanda submitted its sNDA in October 2018, issuing a complete response letter in August 2019 and not providing a timely hearing opportunity.
January 30, 2024 | 12:08 am
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Vanda Pharmaceuticals Inc. won a summary judgment against the FDA, which could expedite the approval process for HETLIOZ® to treat jet lag disorder.
The court ruling in favor of Vanda Pharmaceuticals may lead to a positive investor sentiment as it removes a significant regulatory hurdle and could accelerate the approval process for HETLIOZ®. This could potentially increase the drug's time to market and revenue prospects, positively impacting VNDA's stock price in the short term.
CONFIDENCE 85
IMPORTANCE 90
RELEVANCE 100