reports
Tonix Pharmaceuticals Announces Presentation at Planet MicroCap Showca...
Tonix Pharmaceuticals Announces Presentation at Planet MicroCap Showcase CHATHAM, N.J., April 24, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that Seth Lederman, M.D., Chief Executive Officer, will present at the Planet MicroCap Showcase in Las Vegas, Nev. on May 1, 2024, at 8:00 a.m. PT (11:00 a.m. ET). The presentation will include data from the recently reported positive Phase 3 RESILIENT trial of Tonmya™ (also known as TNX...
Tonix Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financ...
Tonix Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results and Operational Highlights Positive results from confirmatory Phase 3 RESILIENT study reported in December 2023 position Tonmya™ for fibromyalgia for NDA submission second half of 2024; pre-NDA meeting with FDA scheduled for second quarter 2024 Commercial planning underway, including go-to-market, supply chain and manufacturing strategies, for U.S. launch of Tonmya, a potential new first-line, centrally-acting, non-opioid analgesic for the management of fibromyalgia CHATHAM, N.J., April 01, 2024 (GLOBE NEW...
Tonix Pharmaceuticals Announces Pricing of $4.4 Million Registered Dir...
Tonix Pharmaceuticals Announces Pricing of $4.4 Million Registered Direct Offering CHATHAM, N.J., March 28, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a biopharmaceutical company, today announced it has entered into a securities purchase agreement with existing healthcare focused institutional investors of the Company for the purchase and sale of 14,666,666 shares of its common stock (or common stock equivalents in lieu thereof) and warrants to purchase up to an aggregate of 14,666,666 shares of common stock in a registered dire...
Tonix Pharmaceuticals Receives Rare Pediatric Disease Designation from...
Tonix Pharmaceuticals Receives Rare Pediatric Disease Designation from the FDA for TNX-2900 for the Treatment of Prader-Willi Syndrome TNX-2900 is a proprietary magnesium-potentiated formulation of intranasal oxytocin, a naturally occurring hormone that reduces appetite and eating Prader Willi syndrome is the most common genetic cause of life-threatening childhood obesity CHATHAM, N.J., March 25, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidat...
Tonix Pharmaceuticals Announces Poster Presentation Describing Discove...
Tonix Pharmaceuticals Announces Poster Presentation Describing Discovery of Novel Next-Generation Oxytocin Analogues at the American Chemistry Society (ACS) Spring 2024 Meeting Four Phase 2 investigator-initiated studies of TNX-1900 (intranasal potentiated oxytocin) are ongoing for pediatric obesity, binge eating disorder, bone health in autism and social anxiety disorder TNX-2900 (intranasal potentiated oxytocin) is being developed under an IND as a treatment for Prader-Willi Syndrome, an Orphan Disease characterized by excessive eating TNX-1900 and TNX-2900 may serve as novel n...
Tonix Pharmaceuticals Announces Selection of Two Contract Manufacturin...
Tonix Pharmaceuticals Announces Selection of Two Contract Manufacturing Organizations for the Launch and Commercial Manufacture of Tonmya™ for the Management of Fibromyalgia Tonmya™ is a potential new first-line, centrally acting non-opioid analgesic for the management of fibromyalgia, supported by positive results from two Phase 3 studies New Drug Application (NDA) submission to the FDA planned for second half of 2024 CHATHAM, N.J., March 20, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed pro...
Tonix Pharmaceuticals Announces Transition to Fully Integrated Biophar...
Tonix Pharmaceuticals Announces Transition to Fully Integrated Biopharmaceutical Company Expected on April 1, 2024 Zembrace® SymTouch® and Tosymra® will be marketed by Tonix Medicines, Tonix’s wholly-owned commercial subsidiary Commercial capabilities prepare Tonix for the potential launch in 2025 of Tonmya™ for the management of fibromyalgia, assuming FDA approval CHATHAM, N.J., March 19, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today ...
Tonix Pharmaceuticals Announces Presentation at BIO-Europe Spring
Tonix Pharmaceuticals Announces Presentation at BIO-Europe Spring Tonix recently reported results from second positive Phase 3 trial of Tonmya™ for the management of fibromyalgia In the U.S., New Drug Application (NDA) submission to the FDA planned for the second half of 2024 In Japan, China and most countries in Europe cyclobenzaprine is a New Chemical Entity CHATHAM, N.J., March 12, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today anno...
Tonix Pharmaceuticals Reports Improvement in “Brain Fog,” in Fibromyal...
Tonix Pharmaceuticals Reports Improvement in “Brain Fog,” in Fibromyalgia Patients Treated with Tonmya™ in RESILIENT, an NDA-Enabling Phase 3 Clinical Trial, at the 6th International Congress on Controversies in Fibromyalgia Phase 3 RESILIENT study of Tonmya met its primary endpoint of daily pain reduction (p=0.00005) and achieved statistically significant improvement on all six key pre-specified secondary endpoints with effect sizes on sleep, fatigue, FIQ-R symptoms and FIQ-R function ranging from 0.3 to 0.5 Cognitive dysfunction, or “brain fog,” nominally improved on FIQ-R memory item (p...
Tonix Pharmaceuticals Announces Publication in Psychiatry Research Sho...
Tonix Pharmaceuticals Announces Publication in Psychiatry Research Showing Activity of Bedtime TNX-102 SL on PTSD Symptoms and Sleep Quality in Military-Related PTSD at Four Weeks of Therapy Data support evaluation of the effects of two weeks of TNX-102 SL therapy on severity of acute stress reaction (ASR) and frequency of acute stress disorder (ASD) and PTSD after civilian motor vehicle collision in upcoming U.S. DoD-Funded Phase 2 investigator-initiated OASIS trial Nominal improvement in PTSD severity and measures of sleep quality at Week 4 in the HONOR study support development of bedti...
Tonix Pharmaceuticals Selects EVERSANA® to Support Launch Strategy and...
Tonix Pharmaceuticals Selects EVERSANA® to Support Launch Strategy and Commercialization Planning of Tonmya™ for the Management of Fibromyalgia Tonmya is a potential new first-line, centrally acting non-opioid analgesic for the management of fibromyalgia, supported by statistically significant results from two Phase 3 trials New Drug Application (NDA) submission to the FDA planned for the second half of 2024 CHATHAM, N.J., March 06, 2024 (GLOBE NEWSWIRE) -- (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development ca...
Tonix Pharmaceuticals Announces Translation of Preclinical Pharmacokin...
Tonix Pharmaceuticals Announces Translation of Preclinical Pharmacokinetic Parameters of TNX-1500 (Fc-modified humanized anti-CD40L mAb) Supports Monthly i.v. Dosing in Humans TNX-1500, a third generation anti-CD40L mAb, was Fc-modified to preserve the activity and bioavailability of first generation mAbs while addressing their thrombosis risk Sanofi projects its Fc-modified humanized anti-CD40L mAb frexalimab will exceed €5B per year in peak sales1 based on Phase 2 multiple sclerosis data recently published in the New England Journal of Medicine2 Topline results of TNX-1500 Phase 1 tria...
Tonix Pharmaceuticals Announces Presentation at The 6th International ...
Tonix Pharmaceuticals Announces Presentation at The 6th International Congress on Controversies in Fibromyalgia Additional data from recently reported positive Phase 3 RESILIENT trial will be presented CHATHAM, N.J., Feb. 29, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that Seth Lederman, M.D., Chief Executive Officer, will present at The 6th International Congress on Controversies in Fibromyalgia in Brussels, Belgium on Mar...
Tonix Pharmaceuticals Completes Clinical Stage of Phase 1 Trial for TN...
Tonix Pharmaceuticals Completes Clinical Stage of Phase 1 Trial for TNX-1500 (Fc-modified humanized anti-CD40L mAb) in Healthy Volunteers Topline results expected in the third quarter of 2024; planning a Phase 2 Trial for prevention of kidney transplant rejection Anti-CD40L has multiple possible indications in addition to solid organ and bone marrow transplantation including autoimmune diseases: potential pipeline in a product Sanofi recently published results on their Fc-modified humanized anti-CD40L mAb, frexalimab, for multiple sclerosis in the New England Journal o...
Tonix Pharmaceuticals Announces Positive Results from Clinical Pharmac...
Tonix Pharmaceuticals Announces Positive Results from Clinical Pharmacokinetic Bridging Study of Tonmya™ to Support Development and Partnering in Japan and China Tonix plans to File a Clinical Trial Notification (CTN) in Japan and Investigational New Drug (IND) application in China to support a registration-enabling Asian Phase 3 study without dosage adjustment based on U.S. registrational Phase 3 data Tonmya’s market exclusivity is supported by issued patents in Japan, China, Hong Kong and Taiwan; cyclobenzaprine is a new chemical entity in Japan and China New Drug Application (NDA) subm...
Tonix Pharmaceuticals to Participate in the 2024 BIO CEO & Investor Co...
Tonix Pharmaceuticals to Participate in the 2024 BIO CEO & Investor Conference CHATHAM, N.J., Feb. 20, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals, will present at the BIO CEO & Investor Conference on February 26, 2024 at 1:30 p.m. ET in New York City. Investors interested in arranging a meeting with the Company’s management during th...
Tonix Pharmaceuticals Hosted KOL Webinar on Positive Phase 3 Fibromyal...
Tonix Pharmaceuticals Hosted KOL Webinar on Positive Phase 3 Fibromyalgia Trial for Tonmya™, Plans to File NDA for FDA Approval in Second Half of 2024 Clinical results show that Tonyma™ has broad-spectrum activity, addressing the three core fibromyalgia symptoms: pain, fatigue, and sleep disturbance Tonmya™ has a favorable tolerability profile well-suited for chronic treatment CHATHAM, N.J., Feb. 14, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidat...
Tonix Pharmaceuticals Announces Engagement of Rho as CRO to Support Su...
Tonix Pharmaceuticals Announces Engagement of Rho as CRO to Support Submission of New Drug Application to the FDA for Approval of Tonmya™ for the Management of Fibromyalgia Tonmya™ is a potential new first-line therapy, non-opioid analgesic for the management of fibromyalgia, supported by statistically significant results from two Phase 3 trials New Drug Application (NDA) submission to the FDA planned for second half of 2024 Fibromyalgia is a chronic pain condition affecting approximately 10 million U.S. adults that typically persists for years or decades CHATHAM, N.J., Feb. 13, 2...
Tonix Pharmaceuticals Announces FDA IND Clearance for DoD Funded Trial...
Tonix Pharmaceuticals Announces FDA IND Clearance for DoD Funded Trial of TNX-102 SL for the Reduction of Acute Stress Reaction and Prevention of PTSD Bedtime TNX-102 SL improves sleep quality in PTSD and is also being developed for the management of fibromyalgia for which NDA preparation is ongoing Investigator-Initiated OASIS Trial at UNC is a Phase 2 180-patient, randomized, placebo-controlled trial in acute trauma patients following motor vehicle collisions One-third of emergency department visits in the U.S. (40-50 million patients per year) involve evaluation after trauma exposures ...
Tonix Pharmaceuticals Announces Research Indicating Pre-Existing Fibro...
Tonix Pharmaceuticals Announces Research Indicating Pre-Existing Fibromyalgia-Type Symptoms May Increase the Risk of Developing Long COVID Retrospective observational study of electronic medical records of more than 90 million people living in the U.S. Long COVID shares symptoms with chronic overlapping pain disorders like fibromyalgia and appears mechanistically related Tonix is studying TNX-102 SL for both the management of fibromyalgia and management of fibromyalgia-type Long COVID. CHATHAM, N.J., Jan. 31, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: T...
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