Tonix Pharmaceut Stock Price, News & Analysis

Tonix Pharmaceuticals (TNXP) presented data at the AAPM 2025 Annual Meeting regarding TNX-102 SL, their sublingual cyclobenzaprine formulation for fibromyalgia treatment. The drug demonstrated statistically significant improvement in reducing fibromyalgia pain in two pivotal Phase 3 studies.

The FDA has set a PDUFA date of August 15, 2025 for TNX-102 SL. If approved, it would become the first new drug for fibromyalgia treatment in over 15 years and the first in a new class of non-opioid analgesics.

The drug, designed as a bedtime treatment targeting non-restorative sleep, works as a potent antagonist at four post-synaptic receptors. Its transmucosal delivery system bypasses first-pass hepatic metabolism, resulting in greater bioavailability of cyclobenzaprine aligned with the sleep cycle.

Tonix Pharmaceuticals (NASDAQ: TNXP) has announced that CEO Seth Lederman will present at the 2025 Jones Trading Healthcare and Innovation Conference on April 9, 2025, at 10:00 a.m. PT in Las Vegas.

The company's key developments 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
• A new $34 million DoD contract for developing TNX-4200 antiviral agents

Tonix Medicines currently markets Zembrace SymTouch and Tosymra for acute migraine treatment in adults.

Tonix Pharmaceuticals (TNXP) has launched TONIX ONE™, a comprehensive digital platform for migraine management. The platform integrates partnerships with UpScript Telemedicine, ProModRx, Blink Health, and a leading migraine diary app to streamline patient care from symptom tracking to prescription fulfillment.

The platform offers educational resources about migraines, connects patients with specialists via telehealth, and facilitates e-prescription requests. Through the integrated mobile application, patients can track symptoms and gather data-driven insights to optimize their treatment.

Additionally, Tonix provided updates on its development portfolio, including TNX-102 SL for fibromyalgia with a PDUFA date of August 15, 2025, and various other candidates in development such as TNX-1300 for cocaine intoxication and TNX-1500 for organ transplant rejection. The company also highlighted a recent DoD contract worth up to $34 million for developing TNX-4200.

Tonix Pharmaceuticals (NASDAQ:TNXP) is advancing TNX-102 SL, a non-opioid treatment for fibromyalgia, with potential FDA approval by August 15, 2025. The sublingual medication, taken at bedtime, targets sleep disturbance in fibromyalgia patients, addressing a critical market need where 85% of patients fail first-line therapy.

The chronic pain drug market, including fibromyalgia, is projected to grow from $72.10 billion in 2024 to $115.51 billion by 2031. TNX-102 SL could serve both traditional fibromyalgia patients and Long COVID sufferers, as fibromyalgia has been recognized as a diagnosable condition in Long COVID by the National Academies of Science, Engineering and Medicine. According to recent data, approximately 17.8 million U.S. adults have long COVID.

Tonix Pharmaceuticals (TNXP) announced a presentation at the AAPM 2025 Annual Meeting in Austin, Texas. The company's CEO will present a poster on April 5, 2025.

Key highlights include the pending FDA decision for TNX-102 SL for fibromyalgia management, with a PDUFA date of August 15, 2025. The drug received Fast Track designation and is supported by two statistically significant Phase 3 studies.

The company's pipeline includes TNX-1300 for cocaine intoxication (Phase 2, Breakthrough Therapy designation), TNX-1500 for organ transplant rejection, and TNX-801 for mpox. Notably, Tonix secured a DoD contract worth up to $34 million for developing TNX-4200, targeting CD45.

Through Tonix Medicines, the company markets Zembrace SymTouch and Tosymra for acute migraine treatment in adults.

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.