Tonix Unveils Once-Yearly Lyme Prevention Antibody, Eyes FDA Talks In 2026

Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) on Monday announced program updates on TNX-4800 (formerly known as mAb 2217LS), a long-acting human monoclonal antibody (mAb) that targets the outer surface protein A (OspA) of Borrelia burgdorferi, the causative agent of Lyme disease in humans.

TNX-4800 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.

There are no currently marketed U.S. Food and Drug Administration (FDA)-approved vaccines or prophylactics to protect against Lyme disease.

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“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)3-5 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 company, in a press release on Monday, said approximately 70 million people who live, work, or vacation in areas of the U.S. in which Lyme disease is endemic could potentially benefit from pre-exposure prophylaxis.

Pricing of Registered Direct Offering

Concurrently, Tonix Pharmaceuticals announced a securities purchase agreement with Point72 for 615,025 shares at $16.26 per share and pre-funded warrants to purchase up to 615,025 shares at $16.259 per pre-funded warrant, with gross proceeds of approximately $20.0 million.

The company will use the proceeds to fund the commercialization of its marketed products, the development of its product pipeline, and 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, according to Benzinga Pro data.

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