Tonix Pharmaceuticals Announces FDA Acceptance of the New Drug Application (NDA) for TNX-102 SL for Fibromyalgia
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Tonix Pharmaceuticals announced that the FDA has accepted the New Drug Application for TNX-102 SL, a treatment for fibromyalgia. The FDA will assign a PDUFA target action date and decide on Priority Review in the Day 74 Letter.
December 17, 2024 | 1:15 pm
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Tonix Pharmaceuticals' NDA for TNX-102 SL has been accepted by the FDA, which is a significant step in the drug approval process. The decision on Priority Review and the PDUFA date will be crucial for the company's future prospects.
The acceptance of the NDA by the FDA is a positive development for Tonix Pharmaceuticals, as it indicates progress in the drug approval process. The upcoming PDUFA date and Priority Review decision could further impact the stock positively if favorable.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100