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Tonix Pharmaceuticals Holding Corp. (TNXP)

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(+1.91%)

At close: 4:00 PM EDT

0.1587

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(-0.81%)

After hours: 4:44 PM EDT

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 NEWSWIRE) -- Tonix

GlobeNewswire 18 days ago
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 reg

GlobeNewswire 22 days ago
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 candidates, today announced the U.S. Food and Drug Adm

GlobeNewswire 25 days ago
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 neuroendocrine treatments for certain pain, eating and endocrine disorders CHATHAM, N.J., Ma

GlobeNewswire 29 days ago
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 products and a pipeline of development candidates, today announced it has selected t

GlobeNewswire 30 days ago
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 announced that it will

GlobeNewswire last month
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 developme

GlobeNewswire last month
TNXP: Tonmya™ May Launch Alongside Another New Fibromyalgia Treatment…

By David Bautz, PhD NASDAQ:TNXP READ THE FULL TNXP RESEARCH REPORT Business Update Two New FDA Approved Fibromyalgia Treatments Possible in 2025 In the second half of 2024, Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) will be filing a new drug application (NDA) for TNX-102 SL (conditionally accepted trade name Tonmya™) for the treatment of fibromyalgia. The filing will be based in part on

Zacks Small Cap Research last month
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=0.001) where the patients rated their level of memory problems NDA submission expected in the second half of 2024 following pre-

GlobeNewswire last month
New to The Street Announces TV Episode 560 with its Five Business Guest Interviews, Airs as Sponsored Programming on Bloomberg TV Tonight, Thursday, March 7, 2024, at 9:30 PM PT

New to The Street Announces TV Episode 560 with its Five Business Guest Interviews, Airs as Sponsored Programming on Bloomberg TV Tonight, Thursday, March 7, 2024, at 9:30 PM PT Show 560: 1). PetVivo Holdings, Inc. (NASDAQ: PETV) (NASDAQ: PETVW) ($PETV) 2). Tonix Pharmaceuticals, Inc. (NASDAQ: TNXP) ($TNXP) 3). VRM BioLogik® Group (VRM) 4). Blue Castle Ventures LTD ($BCVD) 5). Sekur Private Data, Ltd. (OTCQB: SWISF) (CSE: SKUR) (FRA: GDT0) ($SWISF) (Sekur®) - www.newtothestreet.com NEW YORK, Mar

GlobeNewswire last month
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 bedtime TNX-102 SL therapy in the immediate aftermath of trauma TNX-102 SL (Tonmya™) is also in late

GlobeNewswire last month
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) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, announced toda

GlobeNewswire last month
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 trial expected in the third quarter of 2024; clinical stage completed last month TNX-1

GlobeNewswire last month
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 presentedCHATHAM, 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 March 7, 2024. The pres

GlobeNewswire last month
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 of Medicine1 CHATHAM, N.J., Feb. 28, 2024 (GLOBE NEWSWIRE) -- To

GlobeNewswire last month
Tonix Pharmaceuticals drug TNX-102 SL gets FDA ok for US Department of Defense funded trial

Tonix Pharmaceuticals CEO Dr. Seth Lederman joined Steve Darling from Proactive to share significant news regarding the company's latest development: the clearance of the Investigational New Drug a...

News Direct last month
Tonix Pharmaceuticals' Fibromyalgia Trial Shows Promising Results in Webinar Presentation

Tonix Pharmaceuticals CEO Dr. Seth Lederman joined Steve Darling from Proactive to share positive Phase 3 data on Tonmya, also known as TNX-102 SL, for the management of fibromyalgia, and discussed...

News Direct last month
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) submission to the U.S. FDA for the approval of Tonmya for the managemen

GlobeNewswire last month
New Drug Study Shows Improving Sleep Quality Can Relieve Fibromyalgia Pain

Bedtime drug being developed by Tonix relieved pain by targeting fibromyalgia's characteristic "non-restorative sleep": Potential for FDA Approval in 2025 CHATHAM, NJ / ACCESSWIRE / February 26, 2024 / People who are suffering from fibromyalgia pain ...

ACCESSWIRE last month
New to The Street Announces Line-up of its Corporate Interviews Airing on its Leadership and Business Televised Series

"New to The Street Leadership" Broadcast on Bloomberg TV as Sponsored Programming on Saturday, February 24, 2024, at 6:30 PM ET, and the "New to The Street" Business Broadcast on the FOX Business Network, Monday, February 26, 2024, at 10:30 PM PT "New to The Street Leadership" Broadcast on Bloomberg TV as Sponsored Programming on Saturday, February 24, 2024, at 6:30 PM ET, and the "New to The Street" Business Broadcast on the FOX Business Network, February 26, 2024, at 10:30 PM PT Featuring: 1).

GlobeNewswire last month

Performance Overview

Return	TNXP	S&P 500
YTD	-60.00%	+4.14%
1-Year	-94.98%	+19.55%
3-Year	-99.92%	+18.68%

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Tonix Pharmaceuticals Holding Corp. (TNXP)

Tonix Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results and Operational Highlights

Tonix Pharmaceuticals Announces Pricing of $4.4 Million Registered Direct Offering

Tonix Pharmaceuticals Receives Rare Pediatric Disease Designation from the FDA for TNX-2900 for the Treatment of Prader-Willi Syndrome

Tonix Pharmaceuticals Announces Poster Presentation Describing Discovery of Novel Next-Generation Oxytocin Analogues at the American Chemistry Society (ACS) Spring 2024 Meeting

Tonix Pharmaceuticals Announces Selection of Two Contract Manufacturing Organizations for the Launch and Commercial Manufacture of Tonmya™ for the Management of Fibromyalgia

Tonix Pharmaceuticals Announces Transition to Fully Integrated Biopharmaceutical Company Expected on April 1, 2024

Tonix Pharmaceuticals Announces Presentation at BIO-Europe Spring

TNXP: Tonmya™ May Launch Alongside Another New Fibromyalgia Treatment…

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

New to The Street Announces TV Episode 560 with its Five Business Guest Interviews, Airs as Sponsored Programming on Bloomberg TV Tonight, Thursday, March 7, 2024, at 9:30 PM PT

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

Tonix Pharmaceuticals Selects EVERSANA® to Support Launch Strategy and Commercialization Planning of Tonmya™ for the Management of Fibromyalgia

Tonix Pharmaceuticals Announces Translation of Preclinical Pharmacokinetic Parameters of TNX-1500 (Fc-modified humanized anti-CD40L mAb) Supports Monthly i.v. Dosing in Humans

Tonix Pharmaceuticals Announces Presentation at The 6th International Congress on Controversies in Fibromyalgia

Tonix Pharmaceuticals Completes Clinical Stage of Phase 1 Trial for TNX-1500 (Fc-modified humanized anti-CD40L mAb) in Healthy Volunteers

Tonix Pharmaceuticals drug TNX-102 SL gets FDA ok for US Department of Defense funded trial

Tonix Pharmaceuticals' Fibromyalgia Trial Shows Promising Results in Webinar Presentation

Tonix Pharmaceuticals Announces Positive Results from Clinical Pharmacokinetic Bridging Study of Tonmya™ to Support Development and Partnering in Japan and China

New Drug Study Shows Improving Sleep Quality Can Relieve Fibromyalgia Pain

New to The Street Announces Line-up of its Corporate Interviews Airing on its Leadership and Business Televised Series

Performance Overview