Tonix Pharmaceuticals Hld

Tonix Pharmaceuticals Holding Corp. is a clinical-stage biopharmaceutical company, which focuses on the discovery, acquisition, and development of small molecules and biologics to treat and prevent human disease and alleviate suffering. Its portfolio includes TNX-102 SL, TNX-601, TNX-801, and TNX-1800. The company was founded by Seth Lederman and Donald W. Landry on November 16, 2007 and is headquartered in Chatham, NJ.

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Tonix received FDA's Day 74 Letter granting TNX-102 SL a Prescription Drug User Fee Act (PDUFA) goal date of August 15, 2025

Tonix Pharmaceuticals Announces PDUFA Goal Date of August 15, 2025, for FDA Decision on U.S. Marketing Approval for TNX-102 SL for Fibromyalgia

Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced that the US Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for TNX-102 SL, a non-opioid, centrally acting analgesic designed for fibromyalgia management.

FDA accepts Tonix's NDA for non-opioid fibromyalgia drug TNX-102 SL

FDA is expected to assign a Prescription Drug User Fee Act (PDUFA) target action date and announce whether Priority Review has been granted in the Day 74 Letter

Tonix Pharmaceuticals Announces FDA Acceptance of the New Drug Application (NDA) for TNX-102 SL for Fibromyalgia

Submitted New Drug Application (NDA) to FDA for TNX-102 SL for fibromyalgia based on two statistically significant Phase 3 studies

Tonix Pharmaceuticals Reports Third Quarter 2024 Financial Results and Operational Highlights

This post was written and published as a collaboration between the in-house editorial team at Benzinga and Tonix Pharmaceuticals Holding Corp. with financial support from Tonix. The two organizations work to ensure that any and all information contained within is true and accurate as of the date hereof to the best of their knowledge and research.

Tonix's TNX 102-SL Could Offer New Hope of Pain Relief Without Narcotics for Fibromyalgia Sufferers

CHATHAM, N.J., Nov. 26, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, announced today that Jessica Morris, Chief Operating Officer of Tonix Pharmaceuticals, will present and conduct investor meetings at NobleCon20, Noble Capital Markets' Twentieth Annual Emerging Growth Equity Conference, being held December 3-4 in Boca Raton, Fla.

Tonix Pharmaceuticals to Participate in the NobleCon20 Investor Conference

Dublin, Nov. 21, 2024 (GLOBE NEWSWIRE) -- The "Muscarinic Acetylcholine Receptor M1 Antagonists - Pipeline Insight, 2024" drug pipelines has been added to ResearchAndMarkets.com's offering. This report provides comprehensive insights about 5+ companies and 8+ pipeline drugs in Muscarinic Acetylcholine Receptor M1 Antagonists pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Muscarinic Acetylcholine Receptor M1 Antagonists Pipeline Research Report 2024: Comprehensive Insights on 8+ Drugs Featuring Tonix Pharmaceuticals, BMS, WinSanTor, and Apnimed

CHATHAM, N.J., Nov. 18, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, announced today that Jessica Morris, Chief Operating Officer of Tonix Pharmaceuticals, will present at the Winter 2024 Investor Summit Virtual on Thursday, November 21, 2024, at 10:00 a.m. ET.

Tonix Pharmaceuticals to Present at the Winter 2024 Investor Summit Virtual

Tonix Pharmaceuticals Targets Rapid Migraine Relief With Non-Oral Treatments

CHATHAM, N.J., Nov. 13, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals, will deliver a poster presentation at the ACR Convergence 2024 Annual Meeting, which will be held in Washington, D.C., November 14-19, 2024. A copy of the Company's presentation will be available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com following the conference. Additional meeting information can be found on the ACR website here.

Tonix Pharmaceuticals Announces Poster Presentation at the American College of Rheumatology (ACR) Convergence 2024 Annual Meeting

The World Health Organization (WHO) declared the spread of new Clade Ib Mpox a public health emergency of international concern (PHEIC): Second Mpox-related WHO PHEIC declaration in two years

Tonix Pharmaceuticals Announces Peer-Reviewed Publication in mSphere Journal Highlighting the Tolerability of Company's Single-Dose Mpox and Smallpox Vaccine Candidate TNX-801, in Immune-Compromised Animals

New data show tolerability and no evidence of spreading to blood or tissues even at high doses of Tonix's attenuated live-virus, minimally replicating vaccine candidate TNX-801 in immunocompromised animals

Tonix Pharmaceuticals Presented Data on Potential Mpox Vaccine TNX-801 at World Vaccine Congress-Europe 2024

CHATHAM, N.J., Oct. 29, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, announced today that Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals, will present at BIO-Europe®, being held November 4-6, 2024, in Stockholm, Sweden. The presentation will take place on Monday, November 4, 2024, at 1:00 p.m. CET.

Tonix Pharmaceuticals to Present at BIO-Europe® 2024

CHATHAM, N.J., Oct. 25, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, announced today that Jessica Morris, Chief Operating Officer of Tonix Pharmaceuticals, will present at the ThinkEquity Conference on Wednesday, October 30, 2024, at 9:30 a.m. ET, and host investor meetings. The conference is being held at the Mandarin Oriental, New York in New York City.

Tonix Pharmaceuticals to Present at the 2024 ThinkEquity Conference

NDA based on two Phase 3 studies of TNX-102 SL in fibromyalgia with statistically significant results on the primary endpoint of reducing widespread pain; generally well tolerated

Tonix Pharmaceuticals Announces Submission of the TNX-102 SL New Drug Application (NDA) for Fibromyalgia to the U.S. Food and Drug Administration (FDA)

AI (Artificial Intelligence) and ML (Machine Learning) drug discovery collaboration will accelerate the development of small molecules as orally available host-targeted broad-spectrum medical countermeasures

Tonix Pharmaceuticals Announces AI Collaboration with X-Chem to Develop Broad-Spectrum Antivirals

The Rush for Non-Addictive Painkillers to Counter the Opioid Crisis Puts Two Companies Close to FDA Decisions

New patent expected to provide market exclusivity into 2036 Zembrace® SymTouch® (sumatriptan succinate injection) 10mg is indicated for the acute treatment of migraine in adults CHATHAM, N.J., Sept. 27, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that the United States Patent and Trademark Office issued U.S. Patent No.

Tonix Pharmaceuticals Announces Issuance of U.S. Patent Covering the Subcutaneous Delivery of FDA-Approved Zembrace® SymTouch® to Treat Migraines

New patent expected to expire in 2030 Tosymra® (sumatriptan nasal spray) 10mg is indicated and marketed for the acute treatment of migraine in adults CHATHAM, N.J., Sept. 19, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that the United States Patent and Trademark Office issued U.S. Patent No.

Tonix Pharmaceuticals Announces Issuance of U.S. Patent by the United States Patent and Trademark Office Covering the Intranasal Delivery of FDA-Approved Tosymra® to Treat Migraines

New Hope for Mpox? How TNX-801 Could Meet the WHO's Vaccine Targets for a Safer, Single-Dose Solution

The World Health Organization (WHO) released its preferred target product profile (TPP) criteria for mpox vaccines at its Mpox Research and Innovation Scientific Conference held August 29-30

Tonix Pharmaceuticals Announces That its Single Dose Mpox Vaccine Candidate TNX-801 Aligns with WHO's Newly Issued Preferred Target Product Profile for Mpox Vaccines in Global Health Emergency

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Gastroparesis slows the ability of the stomach to empty into the small intestine and thereby can delay absorption of oral medications into the bloodstream

Tonix Pharmaceuticals Launches National Awareness Campaign on the Impact of Gastroparesis or Stomach Paralysis on the Absorption of Oral Migraine Medications at PAINWeek

CHATHAM, NJ / ACCESSWIRE / September 4, 2024 / This post was written and published as a collaboration between the in-house editorial team at Benzinga and Tonix Pharmaceuticals Holding Corp. with financial support from Tonix. The two organizations work to ensure that any and all information contained within is true and accurate as of the date hereof to the best of their knowledge and research.

As Research into Pain Accelerates, a Newly Recognized Type of Pain Comes to the Forefront - Tonix Targets it with FDA-Fast Track-Designated TNX-102 SL

Investigator-initiated Phase 2 trial to evaluate TNX-102 SL's potential to reduce severity of acute stress reaction (ASR) and frequency of acute stress disorder (ASD) and posttraumatic stress disorder (PTSD) expected to begin third quarter 2024

Tonix Pharmaceuticals Presented Data from Two Posters on TNX-102 SL for Reduction of Acute Stress Reaction and Prevention of PTSD and One Poster for Wound Healing at the 2024 Military Health System Research Symposium (MHSRS)

News for Tonix Pharmaceuticals Hld Stock (TNXP)