Tonix Pharmaceuticals To Meet With FDA In 2026 To Advance Experimental Lyme Disease Prevention Drug

• Tonix intends to advance TNX-4800 with the goal of submitting an application to the FDA seeking approval to market it.
• The company licensed TNX-4800 from its developers at UMass Chan Medical School in September.
• There are currently no FDA-approved vaccines or preventive medicines to protect against Lyme disease.

Tonix Pharmaceuticals Holding Corp. (TNXP) announced on Monday that it intends to meet with the U.S. Food and Drug Administration in 2026 to discuss the development of its experimental drug in the treatment of Lyme disease.

The company licensed TNX-4800 from its developers at UMass Chan Medical School in September. It is being developed for annual seasonal use, as one subcutaneous administration in the spring to protect against Lyme disease through fall, or the entire tick season in the U.S., without relying on the recipient’s immune system to generate antibodies.

What Is Lyme Disease?

Lyme disease is a bacterial infection caused by the bacterium Borrelia burgdorferi and spread by infected blacklegged ticks. It causes symptoms such as a bull's-eye rash, fever, fatigue, and headaches, and, if untreated, can spread to joints, heart, and brain.

There are currently no FDA-approved vaccines or preventive medicines to protect against Lyme disease. According to Tonix, it is the most common vector-borne infection in the United States, and its incidence is climbing each year.

Tonix Eyes Advancing The Drug

Tonix intends to advance TNX-4800 with the goal of submitting an application to the FDA seeking approval to market it.

“We believe a controlled human infection model (CHIM)3-5 study using Borrelia-infected ticks that mimics natural infection would be a potential path to demonstrating TNX-4800 efficacy for approval,” said CEO Seth Lederman. He added that the firm expects to have the investigational product ready for clinical trials by early 2027.

Registered Direct Offering

Separately, the company also announced the pricing of a $20.0 million registered direct offering on Monday at about $16.26 per share/warrant.  The firm intends to use the net proceeds from the offering to fund the commercialization of its marketed products, the development of its product pipeline, and general working capital and corporate purposes.

How Did Stocktwits Users React?

On Stocktwits, retail sentiment around TNXP stayed within the ‘bearish’ territory while message volume stayed at ‘low’ levels.

A Stocktwits user sounded optimistic about the stock.

TNXP stock is down 51% this year and by about 55% over the past 12 months. 

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