What's Going On With Tonix Pharmaceuticals Stock Today?

Tonix Pharmaceuticals Holding Corp TNXP shares are trading lower Tuesday after initially jumping after the company announced that the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) for TNX-102 SL, a 5.6 mg non-opioid. Here’s what you need to know.

What To Know: The FDA’s acceptance of the NDA triggers a process in which the agency will assign a Prescription Drug User Fee Act (PDUFA) target action date and determine if the application qualifies for priority review, which will be communicated in the Day 74 Letter. TNX-102 SL was granted Fast Track designation by the FDA in July 2024.

Fibromyalgia affects more than 10 million adults in the United States, with the majority being women. TNX-102 SL, if approved, could be the first new drug for treating fibromyalgia in over 15 years and the first member of a new class of analgesic drugs for the condition.

The NDA submission is supported by two Phase 3 studies — RELIEF and RESILIENT — that evaluated TNX-102 SL’s safety and efficacy. Both trials met their primary endpoints, demonstrating a statistical reduction in daily pain compared to placebo.

In the RELIEF study completed in December 2020, results showed significance with a p-value of 0.010. In the confirmatory RESILIENT trial completed in December 2023, significance was observed with a p-value of 0.00005. TNX-102 SL was generally well tolerated in both trials. The most common treatment-related adverse event was temporary numbness of the tongue or mouth at the administration site, which did not lead to significant study discontinuations.

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Tonix Pharmaceuticals’ CEO Seth Lederman noted that the fibromyalgia community has been waiting for a new drug for over 15 years and emphasized that, based on U.S. insurance claims data, fibromyalgia patients are more likely to be prescribed opioids than all three current FDA-approved drugs combined within 18 months of diagnosis.

Tonix is preparing for potential approval in 2025. The company noted that it already has a commercial leadership team in place. Tonix also markets Zembrace SymTouch (sumatriptan injection) and Tosymra (sumatriptan nasal spray) for the acute treatment of migraine.

TNXP Price Action: Tonix shares were up about 25% for the session at the time of writing, but had turned negative by publication time. At last check, Tonix shares were down 7.11% at 49 cents, according to Benzinga Pro.

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