By Chris Wack
Tonix Pharmaceuticals shares were up 51% at $34.67 after the company said the Food and Drug Administration will not require an advisory committee meeting to discuss a New Drug Application for TNX-102 SL for the management of fibromyalgia.
The biopharmaceutical company said that, if approved, TNX-102 SL tablets would be the first new treatment option for fibromyalgia patients in 15 years.
The FDA previously granted Fast Track designation to TNX-102 SL for the management of fibromyalgia in 2024, a designation intended to expedite FDA review of important new drugs to treat serious conditions and fill an unmet medical need.
Tonix shares hit their 52-week low of $6.76 on March 4, and are down 97% in the past 12 months.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
March 24, 2025 09:56 ET (13:56 GMT)
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