Tonix Pharmaceut Stock Price, News & Analysis

Tonix Pharmaceuticals (NASDAQ: TNXP) has received a grant from the Medical CBRN Defense Consortium (MCDC) to support the development of TNX-801, a single-dose mpox and smallpox vaccine candidate. The grant will fund comprehensive market analyses and commercialization planning for both private and government markets.

TNX-801 is an attenuated live-virus vaccine based on synthesized horsepox, demonstrating single-dose immune protection against monkeypox challenge with improved tolerability compared to traditional vaccinia vaccines in animal studies. The development comes as the WHO recently reaffirmed the spread of new clade Ib Mpox as a public health emergency (PHEIC) in February 2025, with cases detected across multiple countries in Africa, Asia, Europe, Middle East, and North America.

The vaccine candidate features potential advantages including single-dose administration for long-term protection and favorable shipping/storage requirements. TNX-801 has previously shown effectiveness in protecting animals against lethal challenge with intratracheal clade I monkeypox virus.

Tonix Pharmaceuticals (TNXP) announced that COO Jessica Morris will present at the 2025 Virtual Investor Summit on March 11, 2025, at 10:30 a.m. ET.

The company's development portfolio highlights include:

• TNX-102 SL for fibromyalgia management, with a PDUFA date of August 15, 2025, and Fast Track designation
• TNX-1300, a Phase 2 biologic with Breakthrough Therapy designation for cocaine intoxication
• TNX-1500 for organ transplant rejection and autoimmune diseases
• TNX-801, a vaccine candidate for mpox

Notable developments include a $34 million DoD contract for developing TNX-4200 antiviral agents. The company operates an infectious disease research facility in Frederick, Md., and markets Zembrace® SymTouch® and Tosymra® for acute migraine treatment through its commercial subsidiary.

Tonix Pharmaceuticals (TNXP) presented data on TNX-102 SL, their sublingual formulation of cyclobenzaprine for fibromyalgia treatment, at the 7th International Congress on Controversies in Fibromyalgia in Vienna. The drug demonstrated statistically significant improvement in reducing fibromyalgia pain in two Phase 3 studies.

TNX-102 SL has a FDA PDUFA date of August 15, 2025, and if approved, would become the first new fibromyalgia treatment in over 15 years. The drug is designed as a bedtime treatment targeting non-restorative sleep, utilizing transmucosal delivery to reduce the formation of norcyclobenzaprine.

In two 14-week Phase 3 trials, TNX-102 SL 5.6 mg met primary endpoints with significant pain reduction compared to placebo, showing good tolerability and no new safety concerns.

Tonix Pharmaceuticals (TNXP) reported preliminary 2024 financial results with $98.8 million in cash as of December 31, 2024. The company generated $10.1 million in net sales from migraine products, up from $7.8 million in 2023. Net operating loss was $126.6 million, including $59.0 million in non-cash impairment charges.

Key highlights include becoming debt-free after repaying a mortgage to JGB Capital, and raising $30.4 million through ATM facility in Q1 2025. The company expects current cash to fund operations into Q1 2026, beyond the FDA PDUFA date of August 15, 2025 for TNX-102 SL fibromyalgia treatment. Operating cash burn decreased to $60.9 million from $102.0 million in the previous year.

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.