Tonix Pharmaceut Stock Price, News & Analysis

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.

Tonix Pharmaceuticals (TNXP) announces two strategic hires to support the launch of TNX-102 SL for fibromyalgia management. Bradley Raudabaugh, MBA, joins as VP Marketing with 25+ years experience, previously VP of Product Strategy at Axsome Therapeutics. Errol Gould, Ph.D., becomes VP Medical Affairs, bringing 25+ years in R&D and medical affairs. The company submitted an NDA for TNX-102 SL in October 2024, with FDA acceptance expected December 2024 and a decision in 2025. If approved, TNX-102 SL would be the first new fibromyalgia drug in over 15 years and the first in a new class of analgesics.

Tonix Pharmaceuticals (Nasdaq: TNXP) announced that Chief Operating Officer Jessica Morris will present at NobleCon20, Noble Capital Markets' Twentieth Annual Emerging Growth Equity Conference on December 3-4 in Boca Raton, Florida. The presentation is scheduled for Tuesday, December 3, 2024, at 12:00 p.m. ET.

The company highlighted its development portfolio, including TNX-102 SL for fibromyalgia management, which has FDA Fast Track designation and awaits an FDA decision on NDA acceptance in December. Other key developments include TNX-1300 for cocaine intoxication treatment, TNX-1500 for organ transplant rejection, and a recent $34 million contract with the U.S. DoD for developing TNX-4200 antiviral agents.

Tonix Pharmaceuticals (Nasdaq: TNXP) announced that Chief Operating Officer Jessica Morris will present at the Winter 2024 Investor Summit Virtual on November 21, 2024, at 10:00 a.m. ET. The company, which focuses on pain management therapies and vaccines, highlighted its development portfolio including TNX-102 SL for fibromyalgia management, currently awaiting FDA review decision in December. The company also develops TNX-1300 for cocaine intoxication and TNX-1500 for organ transplant rejection. Recently, Tonix secured a contract worth up to $34 million with the U.S. DoD's DTRA to develop TNX-4200 antiviral agents. Their commercial subsidiary markets Zembrace SymTouch and Tosymra for acute migraine treatment.

Tonix Pharmaceuticals (TNXP) presented data from their Phase 3 RESILIENT study of TNX-102 SL for fibromyalgia treatment at the ACR Convergence 2024. The study demonstrated statistically significant improvement in the primary endpoint of fibromyalgia nociplastic pain (p-value=0.00005) and all six key secondary endpoints, including sleep quality. The company submitted a New Drug Application to the FDA in October 2024, with a decision expected in 2025. If approved, TNX-102 SL would be the first new fibromyalgia drug in over 15 years and the first in a new class of non-opioid analgesics targeting non-restorative sleep.

Tonix Pharmaceuticals (NASDAQ:TNXP) is marketing two non-oral migraine treatments: Zembrace SymTouch (sumatriptan autoinjector) and Tosymra (sumatriptan nasal spray), designed to provide relief in as little as 10 minutes. These products address limitations of oral medications, which can take 30-60 minutes to work and may be less effective during migraines due to gastroparesis. Clinical trials showed 17% of Zembrace users experienced relief within 10 minutes versus 5% with placebo, while Tosymra achieved 57% pain reduction at two hours compared to 21% with placebo. The company reported $11.3 million in trailing year sales for these migraine products.

Tonix Pharmaceuticals (TNXP) announced a poster presentation at the ACR Convergence 2024 Annual Meeting in Washington, D.C. CEO Seth Lederman will present data on a Phase 3 trial of TNX-102 SL for fibromyalgia. The company awaits FDA decision on NDA acceptance and PDUFA date in December, with potential approval decision in 2025. The FDA has granted Fast Track designation for TNX-102 SL. The company's pipeline includes TNX-1300 for cocaine intoxication, TNX-1500 for organ transplant rejection, and recently secured a DoD contract worth up to $34 million for developing TNX-4200 antiviral agents.