Tonix Pharmaceuticals Holding Corp. - TNXP STOCK NEWS

Tonix Pharmaceuticals (NASDAQ:TNXP) has secured up to $34 million in funding from the U.S. Department of Defense to develop broad-spectrum antiviral agents. The five-year deal with the Defense Threat Reduction Agency (DTRA) aims to improve the medical readiness of military personnel in biological threat environments. Tonix's program will focus on optimizing TNX-4200, an oral CD45 antagonist designed for broad-spectrum efficacy against various viral pathogens.

The company plans to leverage its research facilities, including a BSL-3 lab and ABSL-3 facility in Maryland, to accelerate development. This funding validates Tonix's ongoing research and in-house capabilities, supporting the advancement of its antiviral discovery program beyond the traditional 'one bug, one drug' approach.

Tonix Pharmaceuticals (NASDAQ:TNXP) is preparing to file a New Drug Application (NDA) for Tonmya, its fibromyalgia management drug, in the second half of 2024. The company anticipates FDA approval and commercial launch in the second half of 2025. Tonmya, a non-opioid sublingual tablet, has shown significant improvements in fibromyalgia pain, sleep quality, and other symptoms in clinical trials.

The fibromyalgia market, valued at over $3 billion globally in 2023, has not seen a new FDA-approved drug in over 15 years. Tonix aims to compete in this growing market, which is expected to expand at a 3.8% CAGR from 2024 to 2030. With Tonmya's unique mechanism of action and promising clinical results, Tonix is positioned to potentially disrupt the market currently dominated by generic versions of previous blockbuster drugs.

Tonix Pharmaceuticals (Nasdaq: TNXP) has announced the closing of a $4.0 million public offering. This included 3,393,600 shares of common stock and pre-funded warrants for 3,703,140 shares, priced at $0.57 per share and $0.569 per warrant. The gross proceeds from this offering total $4.0 million, before deducting fees and other expenses. The company plans to use the net proceeds for working capital, general corporate purposes, and to prepare the new drug application for its Tonmya product candidate for fibromyalgia. Dawson James Securities acted as the sole placement agent for this offering. The offering was made under an effective shelf registration statement and filed with the SEC.

Tonix Pharmaceuticals announced a public offering valued at approximately $4.0 million. The firm will issue 7,096,740 shares of common stock at $0.57 per share or pre-funded warrants at $0.569 per warrant. The offering is set to close on July 10, 2024, pending standard conditions. The net proceeds will support general corporate purposes, including preparing a New Drug Application for Tonmya™ and managing existing debt. Dawson James Securities, Inc. is the sole placement agent. The offering follows a shelf registration statement on Form S-3 already filed with the SEC.

Tonix Pharmaceuticals announced a proposed public offering of its common stock or pre-funded warrants. The proceeds will be used for working capital, general corporate purposes, including a new drug application for their product candidate Tonmya™, targeting fibromyalgia, and to address existing debt. Dawson James Securities is the sole placement agent. The offering is subject to market conditions and the terms remain unspecified. The offering is based on an effective shelf registration statement previously filed with the SEC. Investors are encouraged to read the entire prospectus supplement and accompanying documents for more information.

Tonix Pharmaceuticals announced the receipt of formal minutes from a pre-New Drug Application (NDA) meeting with the FDA for Tonmya™ (cyclobenzaprine HCl sublingual tablets), a potential first-line non-opioid treatment for fibromyalgia. The FDA agreed that the proposed data package is sufficient for the NDA submission, which Tonix plans to submit in the second half of 2024, aiming for potential approval by the second half of 2025. The announcement emphasizes Tonmya's potential to benefit fibromyalgia patients, many of whom are dissatisfied with current treatments and often resort to opioids.

Tonix Pharmaceuticals has been awarded a contract by the Defense Threat Reduction Agency (DTRA) worth up to $34 million over five years. The contract aims to develop Tonix's broad-spectrum oral antiviral program, TNX-4200, to enhance the medical readiness of military personnel against biological threats.

The development will focus on optimizing a CD45 antagonist for broad-spectrum efficacy against various viral families, establishing necessary properties for an IND submission, and funding a Phase 1 clinical study. This initiative aligns with the Department of Defense's strategy to develop broad-spectrum antiviral drugs.

The funding will leverage Tonix's advanced research facilities, including BSL-3 and ABSL-3 labs, and prior work on phosphatase inhibitors. The program seeks to provide effective, low-dose antiviral protection with improved safety profiles.

Tonix Pharmaceuticals has closed a $4.0 million public offering, issuing 2,833,900 shares of common stock and pre-funded warrants for 4,228,158 shares. Each share was priced at $0.57, while the pre-funded warrants were priced at $0.569 with an exercise price of $0.001. Gross proceeds are earmarked for working capital, corporate purposes, NDA preparations for Tonmya™ for fibromyalgia, and debt servicing. The offering was executed with Dawson James Securities as the sole placement agent. The prospectus was filed with the SEC and is accessible online.

Tonix Pharmaceuticals announced a public offering of approximately 7,060,918 shares of its common stock at $0.57 per share, expected to close on June 28, 2024. The gross proceeds from the offering will be approximately $4.0 million. The company plans to use the funds for working capital, corporate purposes, and preparing a new drug application for its fibromyalgia treatment, Tonmya™. Dawson James Securities is the sole placement agent for this offering. The transaction is made under an effective shelf registration statement with the SEC.