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Tonix Develops Once-a-Year Lyme Disease Antibody Treatment, Plans FDA Meeting in 2026

MarketDash Editorial Team
2 hours ago
Tonix Pharmaceuticals announced progress on TNX-4800, a long-acting antibody designed to protect against Lyme disease for an entire tick season with just one shot. The company also raised $20 million to fund its development pipeline.

Tonix Pharmaceuticals Holding Corp. (TNXP) announced Monday that it's making progress on TNX-4800, a long-acting human monoclonal antibody that could change the game for Lyme disease prevention. The treatment targets the outer surface protein A (OspA) of Borrelia burgdorferi, which is the bacteria responsible for causing Lyme disease in humans.

Here's the interesting part: TNX-4800 is being developed for annual seasonal use. One subcutaneous shot in the spring would theoretically protect you against Lyme disease through fall, covering the entire tick season in the U.S. Think of it like a flu shot, but for Lyme disease and lasting longer.

This matters because right now, there are no FDA-approved vaccines or prophylactics to protect against Lyme disease. Zero. Which seems odd given how common the disease has become in certain parts of the country.

The Development Timeline

"We plan to meet with the FDA in 2026 to explore Phase 2/3 development options," said Seth Lederman, CEO of Tonix Pharmaceuticals. "We believe a controlled human infection model (CHIM) study using Borrelia-infected ticks that mimics natural infection would be a potential path to demonstrating TNX-4800 efficacy for approval. We are on a path to have investigational product produced under Good Manufacturing Practices (GMP) available for testing early in 2027."

The potential market here is substantial. The company estimates that approximately 70 million people who live, work, or vacation in areas of the U.S. where Lyme disease is endemic could potentially benefit from pre-exposure prophylaxis. That's a lot of hikers, campers, and backyard gardeners who might be interested in a once-yearly shot instead of constantly worrying about tick checks.

Financing the Development

Along with the program update, Tonix announced it secured funding to keep things moving. The company entered into a securities purchase agreement with Point72 for 615,025 shares at $16.26 per share, plus pre-funded warrants to purchase up to 615,025 additional shares at $16.259 per pre-funded warrant. The offering will bring in gross proceeds of approximately $20.0 million.

Tonix plans to use the proceeds to fund the commercialization of its marketed products, develop its product pipeline, and cover general working capital and corporate purposes.

TNXP Price Action: Tonix Pharmaceuticals shares were up 0.80% at $16.39 at the time of publication on Monday.

Back to Stock Market News

Tonix Develops Once-a-Year Lyme Disease Antibody Treatment, Plans FDA Meeting in 2026

MarketDash Editorial Team
2 hours ago
Tonix Pharmaceuticals announced progress on TNX-4800, a long-acting antibody designed to protect against Lyme disease for an entire tick season with just one shot. The company also raised $20 million to fund its development pipeline.

Tonix Pharmaceuticals Holding Corp. (TNXP) announced Monday that it's making progress on TNX-4800, a long-acting human monoclonal antibody that could change the game for Lyme disease prevention. The treatment targets the outer surface protein A (OspA) of Borrelia burgdorferi, which is the bacteria responsible for causing Lyme disease in humans.

Here's the interesting part: TNX-4800 is being developed for annual seasonal use. One subcutaneous shot in the spring would theoretically protect you against Lyme disease through fall, covering the entire tick season in the U.S. Think of it like a flu shot, but for Lyme disease and lasting longer.

This matters because right now, there are no FDA-approved vaccines or prophylactics to protect against Lyme disease. Zero. Which seems odd given how common the disease has become in certain parts of the country.

The Development Timeline

"We plan to meet with the FDA in 2026 to explore Phase 2/3 development options," said Seth Lederman, CEO of Tonix Pharmaceuticals. "We believe a controlled human infection model (CHIM) study using Borrelia-infected ticks that mimics natural infection would be a potential path to demonstrating TNX-4800 efficacy for approval. We are on a path to have investigational product produced under Good Manufacturing Practices (GMP) available for testing early in 2027."

The potential market here is substantial. The company estimates that approximately 70 million people who live, work, or vacation in areas of the U.S. where Lyme disease is endemic could potentially benefit from pre-exposure prophylaxis. That's a lot of hikers, campers, and backyard gardeners who might be interested in a once-yearly shot instead of constantly worrying about tick checks.

Financing the Development

Along with the program update, Tonix announced it secured funding to keep things moving. The company entered into a securities purchase agreement with Point72 for 615,025 shares at $16.26 per share, plus pre-funded warrants to purchase up to 615,025 additional shares at $16.259 per pre-funded warrant. The offering will bring in gross proceeds of approximately $20.0 million.

Tonix plans to use the proceeds to fund the commercialization of its marketed products, develop its product pipeline, and cover general working capital and corporate purposes.

TNXP Price Action: Tonix Pharmaceuticals shares were up 0.80% at $16.39 at the time of publication on Monday.