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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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

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

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 direct offering at a combined offering price of $0.30 per share and accompanying warrant. The warrants have an exercise price of $0.33 per share, will be exercisable commencing six months from the date of issuance and will expire five and one-half years following the date of issuance. The closing of the offering is expected to take place on or about April 1, 2024, subject to the satisfaction of customary closing conditions.

Tonix Pharmaceuticals Announces Pricing of $4.4 Million Registered Direct Offering

TNX-2900 is a proprietary magnesium-potentiated formulation of intranasal oxytocin, a naturally occurring hormone that reduces appetite and eating

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

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Zembrace® SymTouch® and Tosymra® will be marketed by Tonix Medicines, Tonix's wholly-owned commercial subsidiary

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

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 announced that Seth Lederman, M.D.

Tonix Pharmaceuticals Announces Presentation at BIO-Europe Spring

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

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

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

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

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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.

Tonix Pharmaceuticals to Participate in the 2024 BIO CEO & Investor Conference

Non-opioid drug candidate from Tonix lowered pain and also improved sleep and fatigue Latest Phase 3 trial achieved primary endpoint (p=0.00005) Potential for FDA Approval in 2025 CHATHAM, NJ / ACCESSWIRE / February 15, 2024 / People who are suffering from fibromyalgia pain but don't want to risk addiction to an opioid are closer to a new option for treatment. Tonix Pharmaceuticals (NASDAQ:TNXP) reported positive Phase 3 study results for its non-opioid painkiller in late December.

Tonix Drug Shown To Relieve Pain in Fibromyalgia Without Risk of Addiction

Clinical results show that Tonyma™ has broad-spectrum activity, addressing the three core fibromyalgia symptoms: pain, fatigue, and sleep disturbance

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

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

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

Fibromyalgia candidate TNX-102 SL hits primary endpoint of daily pain reduction (p=0.00005) Combination of broad-spectrum relief and favorable tolerability seen as distinguishing, competitive features Company plans to file an NDA for FDA approval in 2H 2024 CHATHAM, NJ / ACCESSWIRE / February 1, 2024 / Tonix Pharmaceuticals (NASDAQ:TNXP) appears to have a potential new weapon against fibromyalgia for the 6-12 million adults in America suffering from its debilitating effects. It has to do with sleep quality, not sleep quantity.

New Hope For Fibromyalgia Patients: Tonix Details Results Of Second Successful Phase 3 Trial And Plans To File For FDA Approval

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.

Tonix Pharmaceuticals Announces Research Indicating Pre-Existing Fibromyalgia-Type Symptoms May Increase the Risk of Developing Long COVID

Results from two positive Phase 3 studies point to Tonmya's (TNX-102 SL) potential as a new first-line medicine for chronic use in managing fibromyalgia, a debilitating condition suffered by 6-12 million adults in the U.S.

Tonix Pharmaceuticals Announces Conditional Acceptance of Tonmya™ as Trade Name for TNX-102 SL for the Management of Fibromyalgia

CHATHAM, N.J., Jan. 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 a key opinion leader (KOL) webinar to discuss the positive Phase 3 data of TNX-102 SL for the management of fibromyalgia.

Tonix Pharmaceuticals Announces KOL Webinar to Discuss Positive Phase 3 Fibromyalgia Data, Sponsored by A.G.P.

As previously announced, Phase 3 RESILIENT study of TNX-102 SL met its primary endpoint (p=0.00005) with statistically significant and clinically meaningful daily pain reduction over placebo

Tonix Pharmaceuticals Presents Additional Data Highlighting the Favorable Tolerability and Differentiated Side Effect Profile of TNX-102 SL in Second Positive Phase 3 Clinical Trial for the Management of Fibromyalgia

TNX-102 SL is a Non-Opioid Analgesic that Demonstrated Daily Pain Reduction Over Placebo (Primary Endpoint, p = 0.00005) and Showed Positive Effects Across All Six Key Secondary Endpoints in Recently Reported Phase 3 Trial

Tonix Pharmaceuticals to Present at Two Upcoming Investor Conferences in January: Focus is on TNX-102 SL for the Management of Fibromyalgia Following Positive Topline Results in Second Pivotal Phase 3 Trial

Led by healthcare-focused institutional investors. $30 million financing upfront with up to an additional $114 million tied to the exercise of warrants.

Tonix Pharmaceuticals Announces Registered Direct Offering of up to $144 Million

Phase 3 RESILIENT study of TNX-102 SL successfully demonstrated daily pain reduction over placebo (primary endpoint, p = 0.00005)

Tonix Pharmaceuticals Announces Highly Statistically Significant and Clinically Meaningful Topline Results in Second Positive Phase 3 Clinical Trial of TNX-102 SL for the Management of Fibromyalgia

Topline Data from a Registration-Enabling Phase 3 Clinical Trial is Due Later This Month. CHATHAM, NJ / ACCESSWIRE / December 14, 2023 / Fibromyalgia is a chronic disorder characterized by widespread pain, fatigue, sleep problems and brain fog.

Hope On The Horizon: Tonix Pharmaceuticals (NASDAQ:TNXP) Could Be On the Cusp of Changing Fibromyalgia Treatment Options With TNX-102 SL

CHATHAM, N.J., Dec. 11, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a 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 the National Academies of Sciences, Engineering, and Medicine Committee on the Current State of Research, Development, and Stockpiling of Smallpox Medical Countermeasures public meeting on Thursday, December 14, 2023 via Zoom. Dr. Lederman will participate in a panel discussion on Vaccine Research & Development taking place from 2:00 - 2:45 p.m. ET.

Tonix Pharmaceuticals to Present at The National Academies Committee on the Current State of Research, Development, and Stockpiling of Smallpox Medical Countermeasures Public Meeting

CHATHAM, N.J., Nov. 28, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a biopharmaceutical company with marketed products and a pipeline of development candidates, announced today that Tonix Management will present and host investor meetings at the following December investor conferences:

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