Tonix Pharmaceuticals Makes Progress on Fibromyalgia Treatment and Grows Its Drug Pipeline

$TNXP

Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) has shared its latest financial results and outlined recent progress across several key drug development programs. The company, based in Chatham, New Jersey, is entering an important period as it moves closer to launching a new treatment for fibromyalgia and expands its pipeline of innovative therapies.

One of the company’s most anticipated developments is the potential FDA approval of TNX-102 SL, a new medication for fibromyalgia. The U.S. Food and Drug Administration (FDA) has set a decision date of August 15, 2025. If approved, TNX-102 SL would be the first new treatment for fibromyalgia in over 15 years—a condition that affects more than 10 million adults in the U.S., most of them women.

The drug has shown results in late-stage clinical trials, helping to reduce pain without the addictive properties linked to opioids. TNX-102 SL uses a sublingual (under-the-tongue) form of cyclobenzaprine, which also helps improve sleep—another major symptom of fibromyalgia. This dual benefit makes the treatment especially promising for patients.

Tonix is also advancing other drug candidates in its pipeline. One of these is TNX-1500, an experimental therapy designed to help prevent kidney transplant rejection and treat autoimmune diseases. Early study results have been positive, and the company plans to begin Phase 2 testing soon.

In infectious disease research, Tonix is working on TNX-801, a vaccine candidate aimed at protecting against mpox (formerly known as monkeypox) and smallpox. The vaccine has shown success in animal testing and is moving toward clinical trials, supported by funding from the U.S. Medical CBRN Defense Consortium (MCDC).

This comes at a time when global mpox outbreaks remain a concern.
Financially, Tonix reports $99 million in cash and cash equivalents, up from the prior year. This funding is expected to support operations through early 2026, including the planned launch of TNX-102 SL if the FDA grants approval.

Tonix’s focus on non-opioid pain relief and treatments for difficult-to-manage diseases aligns with broader healthcare goals. As the company prepares for key milestones, including a potential first-in-class drug for fibromyalgia, it may play a significant role in improving care for patients facing chronic conditions.

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