Tonix Pharmaceuticals Holding Corp. - TNXP STOCK NEWS

Tonix Pharmaceuticals (TNXP) presented data from their Phase 3 RESILIENT study of TNX-102 SL for fibromyalgia treatment at the ACR Convergence 2024. The study demonstrated statistically significant improvement in the primary endpoint of fibromyalgia nociplastic pain (p-value=0.00005) and all six key secondary endpoints, including sleep quality. The company submitted a New Drug Application to the FDA in October 2024, with a decision expected in 2025. If approved, TNX-102 SL would be the first new fibromyalgia drug in over 15 years and the first in a new class of non-opioid analgesics targeting non-restorative sleep.

Tonix Pharmaceuticals (NASDAQ:TNXP) is marketing two non-oral migraine treatments: Zembrace SymTouch (sumatriptan autoinjector) and Tosymra (sumatriptan nasal spray), designed to provide relief in as little as 10 minutes. These products address limitations of oral medications, which can take 30-60 minutes to work and may be less effective during migraines due to gastroparesis. Clinical trials showed 17% of Zembrace users experienced relief within 10 minutes versus 5% with placebo, while Tosymra achieved 57% pain reduction at two hours compared to 21% with placebo. The company reported $11.3 million in trailing year sales for these migraine products.

Tonix Pharmaceuticals (TNXP) announced a poster presentation at the ACR Convergence 2024 Annual Meeting in Washington, D.C. CEO Seth Lederman will present data on a Phase 3 trial of TNX-102 SL for fibromyalgia. The company awaits FDA decision on NDA acceptance and PDUFA date in December, with potential approval decision in 2025. The FDA has granted Fast Track designation for TNX-102 SL. The company's pipeline includes TNX-1300 for cocaine intoxication, TNX-1500 for organ transplant rejection, and recently secured a DoD contract worth up to $34 million for developing TNX-4200 antiviral agents.

Tonix Pharmaceuticals (TNXP) announced the publication of data in mSphere journal showing that their single-dose mpox and smallpox vaccine candidate TNX-801 is well-tolerated in immune-compromised animals. The study demonstrates that TNX-801 is 10 to 1,000-fold more attenuated compared to older vaccinia vaccines. This research comes amid WHO's declaration of two ongoing public health emergencies (PHEICs) related to different mpox clades: the new Clade Ib outbreak affecting 16 African countries and several non-African nations, and the continuing Clade IIb outbreak from 2022. Previously, TNX-801 showed protection against lethal Clade Ia monkeypox challenges in animal studies.

Tonix Pharmaceuticals submitted a New Drug Application (NDA) to FDA for TNX-102 SL for fibromyalgia treatment, based on two successful Phase 3 studies. The drug received Fast Track Designation in July 2024, with an FDA decision expected in December 2024. If approved in 2025, it would be the first new fibromyalgia drug in over 15 years. The company reported Q3 2024 financial results with $28.2 million in cash, $2.8 million in product revenue, and a net loss of $14.2 million. Tonix also secured a DoD contract worth up to $34 million for antiviral drug development.

Tonix Pharmaceuticals (TNXP) has partnered with Kenya Medical Research Institute (KEMRI) to develop a Phase I clinical study for TNX-801, a vaccine candidate for mpox prevention. The study will evaluate the safety, tolerability, and immunogenicity of TNX-801 in Kenya. The vaccine, which showed promising preclinical results, aligns with WHO's preferred target product profile for mpox vaccines, featuring single-dose administration and ambient temperature stability. This development comes as WHO declared mpox a public health emergency, with new Clade Ib cases detected across multiple countries. Tonix also announced a collaboration with Bilthoven Biologics for GMP manufacturing processes.

Tonix Pharmaceuticals presented data on their potential mpox vaccine TNX-801 at the World Vaccine Congress-Europe 2024. The preclinical data showed positive efficacy and tolerability in immunocompromised animals, with no evidence of spreading to blood or tissues even at doses 100-fold higher than traditional vaccinia vaccines. TNX-801, a single-dose attenuated live-virus vaccine, demonstrated protection against lethal clade I monkeypox challenge, preventing clinical disease and lesions while decreasing viral shedding. The vaccine aligns with WHO's preferred target product profile criteria and shows promise in addressing the recent clade I mpox outbreak declared as a Public Health Emergency of International Concern.

Tonix Pharmaceuticals (Nasdaq: TNXP) announced that CEO Seth Lederman will present at BIO-Europe® 2024 on November 4, 2024, at 1:00 p.m. CET in Stockholm, Sweden. The company is developing several key products, including TNX-102 SL for fibromyalgia, which has received FDA Fast Track designation. Their portfolio includes TNX-1300 for cocaine intoxication and TNX-1500 for organ transplant rejection. Notably, Tonix recently secured a contract worth up to $34 million with the U.S. DoD's DTRA to develop TNX-4200, an antiviral agent. The company also markets migraine treatments Zembrace® SymTouch® and Tosymra® through its commercial subsidiary.

Tonix Pharmaceuticals (Nasdaq: TNXP) announced that Chief Operating Officer Jessica Morris will present at the ThinkEquity Conference on October 30, 2024, at 9:30 a.m. ET at the Mandarin Oriental, New York. The company is a fully-integrated biopharmaceutical firm focusing on pain management and public health solutions. Their key development includes TNX-102 SL for fibromyalgia, which has received FDA Fast Track designation. The company recently secured a contract with the U.S. DoD's DTRA worth up to $34 million for developing TNX-4200. Their commercial subsidiary, Tonix Medicines, markets Zembrace SymTouch and Tosymra for acute migraine treatment.