Tonix Pharmaceuticals

Yahoo Finance • 7 days ago

Tonix Pharmaceuticals Announces Positive Pre-IND Meeting with FDA for TNX-102 SL for the Treatment of Major Depressive Disorder

Tonix anticipates filing the IND application in the fourth quarter of 2025 TNX-102 SL is a potential first-in-class treatment for targeting the disturbed sleep associated with depression TNX-102 SL is FDA-approved for the treatment of fi... Full story

Yahoo Finance • 8 days ago

Tonix Pharmaceuticals Announces In-licensing Phase 2/3-Ready Monoclonal Antibody Designed for Seasonal Prevention of Lyme Disease (TNX-4800)

Positive Phase 1 study showed safety, tolerability and a linear pharmacokinetic: pharmacodynamic: efficacy relationship (1: 1: 1) Planning adaptive Phase 2/3 study Approximately 70 million people that are eligible for treatment live in a... Full story

Yahoo Finance • 19 days ago

Mpox in Africa is no longer a global health emergency, WHO chief says

[Blood collection tubes Mpox test positive results,WHO to rename monkeypox as ‘Mpox’] JUN LI The mpox outbreak that originated from Africa last year can no longer be considered a global emergency due to a sustained decline in cases and im... Full story

Yahoo Finance • last month

SA analyst upgrades/downgrades: HD, AAPL, TMUS, TNXP

[Stock market and exchange concept with skyline, bar graph, chart and stock ticker.] Torsten Asmus Home Depot (HD [https://seekingalpha.com/symbol/HD]) sees a downgrade due to overvaluation concerns amidst mixed financial results, while T... Full story

Yahoo Finance • last month

Tonix wins FDA approval of fibromyalgia drug Tonmya

[Neurological diagnosis of Fibromyalgia. Neurological hammer, human brain figure, tools for sensitivity testing are on table next to title of text diagnosis of Fibromyalgia in workplace of neurologist] Shidlovski/iStock via Getty Images... Full story

Yahoo Finance • last month

Tonix Pharmaceuticals stock halted ahead of FDA approval news

Investing.com -- Trading was halted in Tonix Pharmaceuticals (NASDAQ:TNXP) stock Friday ahead of a major announcement that the U.S. Food and Drug Administration (FDA) has approved Tonmya for the treatment of fibromyalgia in adults. The ap... Full story

Yahoo Finance • last month

FDA approves Tonix's fibromyalgia treatment, first in 15 years

CHATHAM, N.J. - Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) announced Friday that the U.S. Food and Drug Administration has approved Tonmya (cyclobenzaprine HCl sublingual tablets) for the treatment of fibromyalgia in adults, marking... Full story

Yahoo Finance • last month

Tonix Pharmaceuticals Announces FDA Approval of Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the Treatment of Fibromyalgia

Tonmya is the first FDA-approved therapy for the treatment of fibromyalgia in over 15 years Fibromyalgia is a chronic pain condition that affects more than 10 million adults in the U.S. who are mostly women Two Pivotal Phase 3 studies de... Full story

Yahoo Finance • last month

Tonix Pharma Gears Up For Key FDA Decision Today, Stock Up Over 500% In 5 Months

(RTTNews) - Tonix Pharmaceuticals Holding Corp. (TNXP) is expected to hear from the FDA its decision on the investigational drug TNX-102 SL, proposed for the management of fibromyalgia, today. Fibromyalgia is a chronic pain disorder resul... Full story

Yahoo Finance • last month

Tonix Pharmaceuticals Reports Second Quarter 2025 Financial Results and Operational Highlights

FDA PDUFA goal date of August 15, 2025, for TNX‑102 SL for fibromyalgia: if approved by FDA, TNX‑102 SL would be the first new drug for fibromyalgia in more than 16 years  In June 2025, the Company was added to the Russell 3000® and Russe... Full story

Yahoo Finance • 2 months ago

Tonix Pharmaceuticals Announces the Launch of the “Move Fibro Forward” Campaign to Bring Awareness to Individuals Impacted by Fibromyalgia

CHATHAM, N.J., July 21, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a fully-integrated biotechnology company, today announced that Tonix Medicines, Inc., its commercial subsidiary, launched the Move Fibro... Full story

Yahoo Finance • 3 months ago

Tonix Pharmaceuticals Announces On-line Publication of Phase 3 RESILIENT Trial Results of TNX-102 SL for Fibromyalgia in the Peer Reviewed Journal, Pain Medicine

The previously disclosed and now published RESILIENT data show that once-nightly TNX-102 SL achieved statistically significant improvement in the primary endpoint of reducing fibromyalgia pain versus placebo, and was generally well tolerat... Full story

Yahoo Finance • 3 months ago

Tonix Pharmaceuticals Announces Oral Presentation on Mpox and Smallpox vaccine candidate TNX-801 at the Vaccine Congress 2025

Single dose vaccination with TNX-801 protects animals from a lethal challenge with monkeypox, the causative agent of mpox TNX-801 confers durable protection after a single dose TNX-801 is well tolerated in immunocompromised animals, with... Full story

Yahoo Finance • 3 months ago

Tonix reports promising cancer treatment data in animal models

CHATHAM, N.J. - Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP), a clinical-stage biopharmaceutical company with a market capitalization of $276 million, announced Wednesday that a combination treatment of its experimental drug mTNX-1700... Full story

Yahoo Finance • 3 months ago

Tonix Pharmaceuticals announces inclusion in Russell 3000, Russell 2000 indexes

Tonix Pharmaceuticals (TNXP) announced that it will be added to the broad-market Russell 3000 Index, with automatic inclusion in the small-cap Russell 2000 Index, after the open of U.S. equity markets today, June 30, 2025, as part of the 2... Full story

Yahoo Finance • 3 months ago

Tonix Pharmaceuticals to be added to Russell 3000, Russell 2000 indexes

Tonix Pharmaceuticals (NASDAQ:TNXP [https://seekingalpha.com/symbol/TNXP]) announced [https://seekingalpha.com/pr/20151424-tonix-pharmaceuticals-announces-inclusion-in-the-russell-3000-and-russell-2000-indexes] on Monday an addition to the... Full story

Yahoo Finance • 3 months ago

Tonix Pharmaceuticals Announces Inclusion in the Russell 3000 ® and Russell 2000 ® Indexes

CHATHAM, N.J., June 30, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biotechnology company, today announced that it will be added to the broad-market Russell 3000... Full story

Yahoo Finance • 3 months ago

Tonix Pharmaceuticals Announces Inclusion in the Russell 3000® and Russell 2000® Indexes

CHATHAM, N.J., June 30, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biotechnology company, today announced that it will be added to the broad-market Russell 3000®... Full story

Yahoo Finance • 3 months ago

Tonix Pharmaceuticals Presented Data and Analyses of TNX-102 SL Treatment Effects on Fibromyalgia at the Annual European Congress of Rheumatology (EULAR) 2025

TNX-102 SL is a sublingual formulation of cyclobenzaprine designed for transmucosal delivery and durable activity in treating fibromyalgia: FDA PDUFA goal date of August 15, 2025 TNX-102 SL demonstrated statistically significant improveme... Full story

Yahoo Finance • 3 months ago

Tonix Pharmaceuticals Announces Appointment of Commercial Industry Veteran, James “Jim” Hunter, to Board of Directors

Mr. Hunter brings more than 40 years of experience building and leading commercial organizations in the biopharmaceutical industry, including leadership roles at Validus Pharmaceuticals, Relialab and Novartis Led launch of Tonix Medicines... Full story