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Tonix Pharmaceuticals Bolsters Leadership Team and Provides Update on TNX-102 SL

• Tonix Pharmaceuticals has appointed Bradley Raudabaugh as Vice President of Marketing and Errol Gould, Ph.D., as Vice President of Medical Affairs to support the potential launch of TNX-102 SL. • Enrollment for the TNX-102 SL OASIS study, which is evaluating the treatment of acute stress reaction and acute stress disorder, is expected to begin in Q1 2025. • The FDA decision on the New Drug Application (NDA) for TNX-102 SL for fibromyalgia is anticipated in August 2025, assuming the NDA is accepted for standard review in December 2024.

Tonix Pharmaceuticals Holding Corp. has expanded its leadership team with the hiring of Bradley Raudabaugh as Vice President of Marketing and Errol Gould, Ph.D., as Vice President of Medical Affairs. This strategic move is intended to support the potential launch of TNX-102 SL, a product candidate for the management of fibromyalgia. The announcement was made on December 3, 2024.

Leadership Expansion

The addition of Mr. Raudabaugh and Dr. Gould to the leadership team signifies Tonix Pharmaceuticals' preparation for the possible commercialization of TNX-102 SL. Their expertise in marketing and medical affairs is expected to be crucial in navigating the market landscape and ensuring effective communication of the drug's clinical benefits.

TNX-102 SL OASIS Study Update

Tonix Pharmaceuticals also provided an update on the TNX-102 SL OASIS study, which is investigating the treatment of acute stress reaction and acute stress disorder. Enrollment for this study is now anticipated to commence in the first quarter of 2025. The OASIS study is a critical component of Tonix's broader strategy to expand the therapeutic applications of TNX-102 SL.

Regulatory Timeline for TNX-102 SL in Fibromyalgia

The company also updated the expected timeline for the U.S. Food and Drug Administration (FDA) decision on the New Drug Application (NDA) for TNX-102 SL in the management of fibromyalgia. The FDA decision is anticipated in August 2025, contingent upon the NDA being accepted for standard review in December 2024. This regulatory milestone is a key focus for Tonix Pharmaceuticals, as it represents a significant step towards addressing the unmet needs in fibromyalgia treatment.

Forward-Looking Statements

The company has cautioned that the announcement contains forward-looking statements regarding product development, clinical trials, regulatory timelines, and potential market opportunities. These statements are subject to risks and uncertainties, and actual results may differ materially from those projected. Tonix Pharmaceuticals undertakes no obligation to update these statements, even if new information becomes available.
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Reference News

[1]
Tonix Pharmaceuticals Holding Corp. filed SEC Form 8-K: Regulation FD Disclosure, Other ...
quantisnow.com · Dec 3, 2024

Tonix Pharmaceuticals Holding Corp. announced the hiring of Bradley Raudabaugh and Errol Gould, updated investor present...

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