Tonix Pharmaceuticals Holding Corp.
June 16, 2025
Company Presentation
Brain Health
Tonix is a fully integrated biopharmaceutical company focused on transforming therapies for pain management and vaccines for public health challenges. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to advance TNX-102 SL, a product candidate for the management of fibromyalgia, for which an NDA was submitted based on two statistically significant Phase 3 studies for the management of fibromyalgia and for which a PDUFA (Prescription Drug User Fee act) goal date of August 15, 2025 has been assigned for a decision on marketing approval. The FDA has also granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD).
Company HQ City:
Chatham
Company HQ State:
NJ
Company HQ Country:
United States
Year Founded:
2011
Lead Product in Development:
TNX-102 SL for the treatment of fibromyalgia
CEO
Dr. Seth Lederman
Year Founded
2011
Development Phase of Lead Product
NDA Preparation/In Review
Number of Unlicensed Products Looking for Licensing
8
Exchange
NASDAQ
Ticker
TNXP
When you expect your next catalyst update?
PDUFA date is August 15, 2025 for TNX-102 SL
What is your next catalyst (value inflection) update?
August 2025
Website
https://www.tonixpharma.com/
Primary Speaker
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