The late-stage candidate TNX-102 SL has received FDA Fast Track status and has delivered positive results in two pivotal Phase 3 trials, demonstrating meaningful pain reduction.
Tonix Pharmaceuticals drew heavy retail chatter on Tuesday ahead of an expected U.S. Food and Drug Administration decision on its experimental fibromyalgia treatment TNX-102 SL, due Friday.
If approved, the drug would be the first new treatment for fibromyalgia in more than 16 years. It’s taken as two 2.8 mg tablets placed under the tongue before bed.
Tonix Pharma’s stock jumped 32.9% to $14.79 on Tuesday, its best session in nearly five months, before edging up another 0.23% in after-hours trading.
The centrally acting, non-opioid analgesic is designed for rapid transmucosal absorption, avoiding first-pass metabolism and reducing levels of a long half-life metabolite.
The treatment earned Fast Track status from the FDA last year. In the late-stage RESILIENT trial, which enrolled 457 patients across 33 U.S. sites, those on TNX-102 SL reported a bigger drop in daily pain scores over 14 weeks compared with placebo, marking a 1.8-point reduction versus 1.2.
It met all six secondary endpoints, and it’s effective for sleep, fatigue, and general functioning. Side effects were mild, temporary, and generally limited to a tingling in the mouth or a bitter aftertaste. There were no serious drug-related adverse events.
Tonix expects to roll out the treatment in the fourth quarter if it receives the green light, and stated that patents should protect U.S. sales until 2034-2035. The company is also testing the drug for other uses, including acute stress reaction, prevention of PTSD, Long COVID, alcohol use disorder, and agitation linked to Alzheimer’s disease.
The rest of Tonix’s pipeline includes a Defense Department–backed study of TNX-102 SL for acute stress reaction, an anti-CD40L antibody called TNX-1500 aimed at preventing organ transplant rejection, and TNX-801, a live-virus vaccine candidate for mpox and smallpox.
As of June 30, Tonix had $125.3 million in cash, plus additional funds from recent stock sales, which it stated will sustain operations through the third quarter of 2026.
In the latest quarter, net revenue totaled $2 million, primarily from migraine drugs, while its net loss narrowed to $28.3 million from $78.8 million in the same period a year earlier.
The company also launched its Move Fibro Forward campaign to raise awareness for fibromyalgia, a condition that affects millions of Americans and has long had limited treatment options.
On Stocktwits, retail sentiment was ‘extremely bullish’ amid a 222% surge in 24-hour message volume, making it one of the platform’s top four trending equities.
One user commented that $TNXP had delivered sixfold gains in six months, citing the second-quarter earnings beat and the upcoming FDA decision as reasons they considered it a “keeper.”
Another user remarked that despite past losses in the stock, the Fast Track status, lack of an advisory committee, and two strong Phase 3 results made the August 15 decision look promising.
Tonix Pharma’s stock has risen 81.2% so far in 2025.
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