Tonix Pharmaceuticals Holding Corp. - TNXP STOCK NEWS

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.

Tonix Pharmaceuticals (NASDAQ: TNXP) has announced a proposed public offering of its common stock or pre-funded warrants. The company intends to utilize the net proceeds for working capital, corporate purposes, including preparing a New Drug Application for its fibromyalgia candidate Tonmya, and addressing existing debt. Dawson James Securities, Inc. will act as the sole placement agent. This offering is subject to market conditions and comes under a previously filed shelf registration statement with the SEC.

Tonix Pharmaceuticals (Nasdaq: TNXP) has regained compliance with Nasdaq's minimum bid price requirement, ensuring its continued listing on The Nasdaq Capital Market. This milestone was achieved after TNXP shares maintained a closing bid price of $1.00 or higher for at least 10 consecutive business days, as confirmed by a Nasdaq letter on June 26, 2024.

Tonix is a biopharmaceutical company specializing in CNS disorders, with a focus on developing therapeutics for conditions such as fibromyalgia and Long COVID. The company plans to submit a New Drug Application (NDA) for its fibromyalgia treatment, Tonmya, in the latter half of 2024. Tonix also aims to address cocaine intoxication, organ transplant rejection, and autoimmune diseases through its diverse development portfolio.

Tonix Pharmaceuticals presented promising data on their live virus vaccine platform at the Vaccine Congress 2024. Their TNX-801 vaccine demonstrated strong efficacy in protecting animals from lethal mpox (formerly monkeypox) challenges. TNX-801, designed for single-dose administration, offers long-term protection against mpox and smallpox. Additionally, their TNX-1800 vaccine for COVID-19 has been selected for clinical trials under NIH’s Project NextGen. The keynote highlighted the potential of these vaccines to address various infectious diseases effectively, with TNX-801 showing better tolerability compared to modern vaccines. The presentation also underscored the ongoing threat of mpox and the urgent need for advanced vaccines.

Tonix Pharmaceuticals has announced positive alignment with the FDA regarding key Chemistry, Manufacturing, and Controls (CMC) topics for their fibromyalgia treatment, Tonmya. The company, which has completed the second pre-New Drug Application (NDA) meeting, discussed nonclinical and clinical matters with the FDA, with formal minutes pending. Tonix is on track to submit the NDA for Tonmya in the second half of 2024. The FDA has agreed on commercial specifications, shelf life, manufacturing, and packaging for Tonmya. Tonix is preparing a dual manufacturing launch strategy with CDMO Almac Pharma Services and another CDMO.

Tonix Pharmaceuticals (Nasdaq: TNXP) presented a poster at the 66th Annual Scientific Meeting of the American Headache Society, highlighting a gap between the real-world use and the guidelines for non-oral migraine treatments. Their FDA-approved products, Zembrace SymTouch and Tosymra, are underutilized according to the data, with usage dropping from 7% in 2012 to below 4% in 2023. The poster stresses the need for personalized migraine treatments and the potential for increased usage of non-oral medications. Zembrace SymTouch offers rapid onset of pain relief in as few as 10 minutes and is the only actively promoted sumatriptan autoinjector in the U.S., while Tosymra provides similar benefits with a single nasal spray.