Tonix Pharmaceut - TNXP STOCK NEWS

Tonix Pharmaceuticals (TNXP) announced positive topline results from its Phase 1 trial of TNX-1500, a next-generation anti-CD40L monoclonal antibody for kidney transplant rejection prevention and autoimmune disease treatment. The trial demonstrated that TNX-1500 effectively blocked primary and secondary antibody responses at 10 mg/kg and 30 mg/kg doses, with a mean half-life of 34-38 days supporting monthly dosing.

The drug showed a favorable safety profile and was generally well-tolerated. The only notable treatment-emergent adverse event was mild aphthous ulcer in three participants. Importantly, no thromboembolic events were reported. The study involved 26 participants across three dosing cohorts (3 mg/kg, 10 mg/kg, and 30 mg/kg), with 24 completing the trial.

Following these results, Tonix plans to discuss with the FDA in an End-of-Phase 1 meeting before proceeding with Phase 2 trials in kidney transplant recipients.

Tonix Pharmaceuticals (TNXP) has announced its participation in the BIO CEO & Investor Conference on February 10, 2025, where CEO Seth Lederman will present at 1:45 p.m. ET in New York City. The company has several key developments in progress, including:

Their priority candidate TNX-102 SL for fibromyalgia management has a PDUFA date of August 15, 2025, and has received Fast Track designation. The company recently submitted an NDA based on two successful Phase 3 studies.

Other significant developments include TNX-1300, a Phase 2 biologic with Breakthrough Therapy designation for cocaine intoxication, and a recent contract with the DoD's DTRA worth up to $34 million for developing TNX-4200. The company also markets migraine treatments Zembrace SymTouch and Tosymra through its commercial subsidiary.

Tonix Pharmaceuticals (TNXP) has promoted Siobhan Fogarty to Chief Technical Officer (CTO), effective immediately. Fogarty, who joined Tonix in 2016, previously served as Executive Vice President of Product Development and brings over 25 years of pharmaceutical industry experience.

The company is preparing for the potential launch of TNX-102 SL, a non-opioid analgesic for fibromyalgia management, with an FDA PDUFA goal date of August 15, 2025. The company's pipeline includes TNX-1300 for cocaine intoxication in Phase 2, TNX-1500 for organ transplant rejection, and TNX-801 for mpox vaccine development.

Tonix recently secured a contract with the U.S. DoD's DTRA worth up to $34 million over five years to develop TNX-4200, targeting CD45 for biological threat prevention. The company currently markets Zembrace SymTouch and Tosymra for acute migraine treatment.

Tonix Pharmaceuticals (TNXP) has announced a 1-for-100 reverse stock split effective February 5, 2025. This corporate action aims to meet NASDAQ's $1.00 minimum bid price requirement for continued listing. The company will maintain its 'TNXP' trading symbol under a new CUSIP number (890260839).

The reverse split will affect common stock and securities like outstanding warrants and stock options. Fractional shares will be rounded up to the nearest whole share, with no cash payments for fractions. The authorized share count will remain unchanged, following shareholder approval obtained on October 30, 2024.

The company is currently awaiting an FDA decision on TNX-102 SL for fibromyalgia management, with a PDUFA date of August 15, 2025. Tonix also has several other products in development, including TNX-1300 for cocaine intoxication and TNX-1500 for organ transplant rejection. Additionally, the company has secured a DoD contract worth up to $34 million for developing TNX-4200.

Tonix Pharmaceuticals (TNXP) has appointed Gary Ainsworth as Vice President of Market Access, effective immediately. Ainsworth brings over two decades of industry experience, having previously served as Managing Director at Eversana Intouch and founder of Havas Gemini's Market Access Business Unit. The appointment comes as Tonix awaits FDA's decision on TNX-102 SL for fibromyalgia management, with a PDUFA date set for August 15, 2025.

The company's development portfolio focuses on CNS disorders, with TNX-102 SL as their priority candidate. The FDA previously granted Fast Track designation for this non-opioid, centrally-acting analgesic. Tonix also has other candidates in development, including TNX-1300 for cocaine intoxication and TNX-1500 for organ transplant rejection. The company recently secured a contract worth up to $34 million with the U.S. DoD's DTRA to develop TNX-4200.

Tonix Pharmaceuticals (TNXP) has announced its participation in two major investor conferences this January. CEO Seth Lederman will present at the 8th Annual Neuroscience Innovation Forum on January 12, 2025, delivering a company presentation at 11:15 a.m. PT and participating in a panel on neuropsychiatric treatments at 1:15 p.m. PT. Additionally, he will present at the 2025 Biotech Showcase on January 14, 2025, at 10:00 a.m. PT.

The company recently submitted an NDA for TNX-102 SL for fibromyalgia management, with a PDUFA date of August 15, 2025. Tonix's pipeline includes TNX-1300 for cocaine intoxication and TNX-1500 for organ transplant rejection. They recently secured a DoD contract worth up to $34 million for developing TNX-4200, an antiviral agent. Their commercial subsidiary, Tonix Medicines, markets Zembrace SymTouch and Tosymra for acute migraine treatment.

Tonix Pharmaceuticals (TNXP) announced that the FDA has set a PDUFA goal date of August 15, 2025, for their TNX-102 SL marketing approval decision for fibromyalgia treatment. The drug, granted Fast Track designation in July 2024, is a non-opioid, centrally-acting analgesic that could become the first new fibromyalgia treatment in over 15 years.

The NDA submission is supported by two successful Phase 3 trials: RELIEF (completed December 2020) and RESILIENT (completed December 2023), both showing statistically significant pain reduction compared to placebo (p=0.010 and p=0.00005 respectively). TNX-102 SL demonstrated favorable tolerability with minimal adverse events, primarily consisting of temporary tongue numbness at the administration site.

Tonix Pharmaceuticals announced FDA acceptance of its New Drug Application (NDA) for TNX-102 SL, a non-opioid analgesic for fibromyalgia management. The drug, granted Fast Track designation in July 2024, could become the first new fibromyalgia treatment in over 15 years. The NDA is supported by two successful Phase 3 trials: RELIEF (completed December 2020) and RESILIENT (completed December 2023), both showing significant pain reduction compared to placebo (p=0.010 and p=0.00005 respectively).

TNX-102 SL was generally well tolerated, with tongue/mouth numbness being the most common side effect. The drug targets a condition affecting over 10 million U.S. adults, predominantly women. The FDA is expected to assign a PDUFA target action date and announce Priority Review status in the Day 74 Letter.

Tonix Pharmaceuticals (NASDAQ: TNXP) has submitted a new drug application (NDA) to the FDA for TNX-102 SL, a non-opioid treatment for fibromyalgia. The drug, which received Fast Track designation, targets sleep problems associated with fibromyalgia through a sublingual formulation of cyclobenzaprine hydrochloride.

In the recent RESILIENT phase 3 trial, TNX-102 SL demonstrated significant improvement in fibromyalgia pain (p-value=0.00005), sleep quality, fatigue, and overall symptoms. The global fibromyalgia market is projected to grow from $2.8 billion in 2024 to $4.13 billion in 2032. Currently, 85% of fibromyalgia patients fail first-line therapy, and 79% require multiple treatments.

FDA's decision on NDA acceptance is expected mid-December 2024, with potential approval by mid-August 2025.