Tonix Pharmaceut Stock Price, News & Analysis

Tonix Pharmaceuticals (TNXP) announced that the FDA will not require an Advisory Committee meeting for its New Drug Application (NDA) for TNX-102 SL, a non-opioid analgesic for fibromyalgia management. The company maintains its PDUFA goal date of August 15, 2025, with potential commercial launch in Q4 2025.

If approved, TNX-102 SL (cyclobenzaprine HCl sublingual tablets) would represent the first new fibromyalgia treatment in over 15 years. The drug received Fast Track designation from the FDA in 2024, highlighting its potential to address an unmet medical need in treating fibromyalgia, which affects more than 10 million adults in the U.S.

Tonix Pharmaceuticals (NASDAQ:TNXP) is developing TNX-801, a single-dose vaccine candidate for mpox, as global cases of the new Clade I strain continue to spread. The current outbreak has caused over 45,000 cases and 1,400 deaths since 2022, with a 3% mortality rate primarily in African countries.

Unlike the 2022 Clade II outbreak that mainly affected gay men, the new Clade I variant spreads within families and particularly affects children, who are more susceptible to severe disease. TNX-801, based on synthesized horsepox, has shown promising results in animal studies, providing single-dose protection against Clade I mpox with better tolerability than traditional vaccinia vaccines.

Current vaccines have limitations: Jynneos requires two doses and is only 66% effective with full dosing, while ACAM2000 has significant side effects. TNX-801 aligns with WHO requirements for an ideal mpox vaccine, offering potential single-dose protection, conventional manufacturing processes, and the ability to limit forward transmission.

Tonix Pharmaceuticals (TNXP) reported its Q4 and full year 2024 financial results, highlighting key developments. The company's lead candidate TNX-102 SL for fibromyalgia has an FDA PDUFA date of August 15, 2025, potentially becoming the first new fibromyalgia treatment in over 15 years.

With $98.8 million in cash as of December 31, 2024, Tonix expects sufficient funding through the PDUFA date and anticipated Q4 2025 product launch. The company reported positive Phase 1 results for TNX-1500, their next-generation anti-CD40L mAb for kidney transplant rejection prevention.

Additional highlights include receiving a government grant for TNX-801, a potential mpox vaccine, and initial payments from a DoD contract worth up to $34 million over five years for developing broad-spectrum antivirals. The company remains debt-free and is actively expanding its commercial team in preparation for TNX-102 SL's potential launch.

Tonix Pharmaceuticals (TNXP) announced its upcoming presentation at the BIO-Europe Spring 2025 Convention in Milan, Italy. CEO Seth Lederman will present on March 17, 2025, focusing on TNX-102 SL for fibromyalgia management.

Key highlights include the FDA's PDUFA goal date of August 15, 2025 for TNX-102 SL marketing authorization decision, potentially becoming the first new fibromyalgia treatment in 15 years. The FDA has granted Fast Track designation to this candidate.

The company recently secured a contract worth up to $34 million with the U.S. DoD's Defense Threat Reduction Agency to develop TNX-4200. Their pipeline includes TNX-1300 for cocaine intoxication with FDA Breakthrough Therapy designation, and TNX-1500 for organ transplant rejection and autoimmune diseases.

Tonix Pharmaceuticals (NASDAQ:TNXP) has reported promising results for TNX-1500, a humanized monoclonal antibody designed to prevent organ transplant rejections and treat autoimmune diseases. The company recently announced topline results from its Phase 1 trial, demonstrating TNX-1500's ability to block immune responses in healthy volunteers with a half-life supporting monthly dosing.

TNX-1500 represents a third-generation CD40L blocker that aims to maintain the effectiveness of first-generation blockers while improving tolerability. The drug shows potential in preventing rejection of both human and pig organ transplants, addressing a critical need as over 100,000 people in the U.S. await organ transplants, with approximately 17 deaths daily due to organ shortages.

The organ transplant immunosuppressant drug market, valued at $5.5 billion in 2023, is projected to reach $7.17 billion by 2030. TNX-1500's development targets both traditional human organ transplants and xenotransplants, with potential expansion into autoimmune conditions. Animal studies have shown promising results with reduced thrombotic events, suggesting successful protein engineering modifications.

Tonix Pharmaceuticals (TNXP) has announced its upcoming presentation at the Zacks SCR Life Sciences Virtual Investor Forum on March 13, 2025, at 3:30 p.m. ET. CEO Seth Lederman will lead an interactive session where investors can engage in real-time questions.

The company's development portfolio highlights include TNX-102 SL for fibromyalgia management, with a PDUFA date of August 15, 2025. The drug has received Fast Track designation and showed positive results in two Phase 3 studies. Other key developments include TNX-1300 for cocaine intoxication treatment (Phase 2) and TNX-1500 for organ transplant rejection prevention.

Tonix's infectious disease portfolio features TNX-801 for mpox and smallpox vaccines, and TNX-4200, supported by a $34 million DoD contract. The company's commercial subsidiary, Tonix Medicines, currently markets Zembrace SymTouch and Tosymra for acute migraine treatment.

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.