On November 15, 2023, The US FDA Informed Orchard Therapeutics It Will Not Schedule An Advisory Committee Meeting For The Review Of The Co's Biologics License Application For The Commercialization Of OTL-200 In The US To Treat Metachromatic Leukodystrophy
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The US FDA has decided not to schedule an advisory committee meeting for Orchard Therapeutics' Biologics License Application for OTL-200, intended to treat Metachromatic Leukodystrophy, according to a recent SEC filing.
November 21, 2023 | 1:13 pm
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Orchard Therapeutics' stock may face negative pressure as the FDA's decision to not hold an advisory committee meeting could be perceived as a setback for the commercialization of OTL-200 in the US.
The FDA's decision to not schedule an advisory committee meeting is often seen as a negative signal for the approval process of a drug. This could lead to investor concern about potential delays or issues with the commercialization of OTL-200, which may negatively impact Orchard Therapeutics' stock price in the short term.
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