Tonix Pharmaceuticals Holding Corp. - TNXP STOCK NEWS

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.

Tonix Pharmaceuticals presented promising Phase 3 results for Tonmya™ (TNX-102 SL) at the EULAR 2024 Congress, showing significant pain reduction and broad symptom improvement for fibromyalgia patients. The RESILIENT study, the second Phase 3 trial, met the primary pain endpoint and all six key secondary endpoints, including sleep quality, fatigue, and overall fibromyalgia symptoms. Tonmya was well tolerated with no new safety signals. An NDA submission to the FDA is planned for the second half of 2024.

Tonix Pharmaceuticals announced the closing of its $4.0 million public offering on June 13, 2024. The offering included 1,199,448 shares of common stock and pre-funded warrants for up to 2,568,110 shares at $1.065 per share and $1.064 per warrant, respectively.

The gross proceeds, totaling $4.0 million, will be used for working capital, general corporate purposes, and preparing a new drug application for Tonmya™, aimed at treating fibromyalgia. Dawson James Securities acted as the sole placement agent. The offering was conducted under an effective shelf registration statement filed with the SEC.

Tonix Pharmaceuticals announced the pricing of a $4.0 million public offering. The offering includes 3,753,558 shares of common stock or pre-funded warrants at $1.065 per share. Gross proceeds will be approximately $4.0 million, with net proceeds used for working capital, corporate purposes, and preparing a new drug application for its Tonmya™ product. Closing is expected around June 13, 2024. Dawson James Securities will act as the sole placement agent. The offering is under an effective shelf registration statement filed with the SEC.

Tonix Pharmaceuticals announced a proposed public offering to sell shares of its common stock or pre-funded warrants, facilitated by Dawson James Securities. The offering is contingent on market conditions, and its completion date and size remain uncertain. The proceeds will support working capital, corporate purposes, including a new drug application for Tonmya™ for fibromyalgia, and debt reduction. The offering is made under an effective shelf registration statement filed with the SEC. Tonix focuses on therapeutics for CNS disorders, including fibromyalgia and Long COVID, and has several drugs in development, such as TNX-1300 and TNX-1500.

Tonix Pharmaceuticals announced a 1-for-32 reverse stock split, effective June 10, 2024. This move aims to increase the stock price to meet NASDAQ's $1.00 minimum bid requirement. Each 32 pre-split shares will convert to one post-split share, impacting outstanding common stock, warrants, and stock options. The company's stock will continue trading under the symbol 'TNXP' with a new CUSIP number, 890260847. Shareholders approved this action on May 22, 2024. Fractional shares will be rounded up, and VStock Transfer will manage the exchange process. No cash will be given for fractional shares.

Tonix Pharmaceuticals announced its participation at the American Transplant Congress 2024, revealing promising data for their drug TNX-1500.

The company shared two oral presentations and one poster presentation. The key highlights include the potential of TNX-1500 as a monotherapy or in combination to prevent organ rejection in allograft and xenograft animal models, promising outcomes in nonhuman primate and gene-edited pig heart models, and the expansion of immune tolerance protocols.

Tonix also completed a Phase 1 study of TNX-1500, assessing its safety and pharmacokinetics, and plans to move to Phase 2 trials in kidney transplant recipients.

Tonix Pharmaceuticals announced a poster presentation at the Annual European Congress of Rheumatology (EULAR) 2024 in Vienna, Austria, from June 12-15, 2024. The presentation will showcase statistically significant Phase 3 results of Tonmya™ (TNX-102 SL) for fibromyalgia management. Tonix plans to submit a New Drug Application (NDA) to the FDA in the second half of 2024. The company's portfolio focuses on CNS disorders, with products like TNX-1300 for cocaine intoxication and TNX-1500 for organ transplant rejection and autoimmune diseases. Tonix also markets Zembrace® SymTouch® and Tosymra® for acute migraine treatment.