Tonix Pharmaceuticals Holding Corp. - TNXP STOCK NEWS

Tonix Pharmaceuticals announced positive results from its Phase 3 RELIEF study of TNX-102 SL for fibromyalgia, significantly reducing daily pain compared to placebo (p=0.01) and improving key secondary endpoints like sleep quality and fatigue. The treatment was well tolerated, showing no side effects common with oral fibromyalgia treatments. The company expects interim analysis results for its ongoing confirmatory study, RALLY, in Q3 2021, followed by topline data in Q1 2022. TNX-102 SL has a favorable patent protection until 2034/2035.

Tonix Pharmaceuticals (Nasdaq: TNXP) announced plans to present two posters at the 2021 ASCP Annual Meeting from June 1-4, 2021. The presentations will focus on TNX-102 SL for treating fibromyalgia and PTSD, showcasing results from their clinical trials. The first poster, on June 2, will detail a Phase 3 trial's positive results in fibromyalgia, while the second, on June 3, will analyze PTSD outcomes. Tonix aims to release interim data from its second Phase 3 study in Q3 2021 and topline data in Q1 2022.

Tonix Pharmaceuticals (Nasdaq: TNXP) announced that CEO Seth Lederman will present at the Q2 Investor Summit Virtual Conference on May 17, 2021, at 3:30 p.m. ET. Investors can arrange virtual meetings with management through the conference coordinator. Tonix focuses on developing therapies for CNS and immunology, with lead candidates including TNX-102 SL for fibromyalgia and TNX-1800, a COVID-19 vaccine. Positive data from animal studies of TNX-1800 were reported in early 2021. Interim data from the RALLY study is expected in Q3 2021.

Tonix Pharmaceuticals (Nasdaq: TNXP) reported Q1 2021 financial results, achieving a cash balance of approximately $164 million, up from $77.1 million at the end of 2020. The company experienced a net loss of $20.7 million, or $0.07 per share, compared to $9 million a year prior. Key updates include positive animal study results for its COVID-19 vaccine candidate TNX-1800 and ongoing development of its CNS programs, with three entering Phase 2 trials this year. An interim analysis for its fibromyalgia treatment, TNX-102 SL, is expected in Q3 2021.

Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced that CEO Seth Lederman will present and join a panel discussion at the 4th Annual Neuroscience Innovation Forum, taking place April 28-30, 2021.

The panel, titled Pain, Migraine & Addiction, is scheduled for April 29 from 11:45 a.m. to 12:45 p.m. ET. The presentation will be available on demand during the event and afterwards on the Tonix website. Tonix focuses on developing therapies for CNS conditions, with key candidates like TNX-102 SL for fibromyalgia.

Tonix Pharmaceuticals (Nasdaq: TNXP) has entered a global licensing agreement with OyaGen for TNX-3500 (sangivamycin), an antiviral drug targeting SARS-CoV-2. Initial studies indicate TNX-3500 exhibits approximately 65 times greater potency than remdesivir against SARS-CoV-2 and shows additive effects when combined with it. This drug is in pre-Investigational New Drug (IND) development and has demonstrated safety in previous human studies. Tonix aims to advance TNX-3500 for regulatory approval in treating COVID-19.

Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced that CEO Seth Lederman will present a company overview at the 20th Annual Needham Virtual Healthcare Conference on April 14, 2021, at 8:00 a.m. ET. Investors can arrange virtual meetings through the conference coordinator. Tonix focuses on CNS and immunology treatments, with its lead CNS candidate, TNX-102 SL, in mid-Phase 3 for fibromyalgia. Positive efficacy data for its COVID-19 vaccine candidate, TNX-1800, was reported, while interim data for the RALLY trial is expected in Q3 2021.

Tonix Pharmaceuticals (Nasdaq: TNXP) announced plans to initiate a Phase 2 Clinical Trial for TNX-601 CR, a novel treatment for Major Depressive Disorder (MDD), pending toxicology study results. Following a recent FDA Type B meeting, the company aims to submit an IND for a human abuse potential study. TNX-601 CR incorporates naloxone to deter misuse. With tianeptine sodium’s established efficacy, TNX-601 CR promises once-daily dosing, potentially improving patient adherence. The company emphasizes its unique mechanism differs from currently approved antidepressants.

Tonix Pharmaceuticals (Nasdaq: TNXP) announced the issuance of U.S. Patent No. 10,946,027 on March 16, 2021, for its development candidate TNX-601 CR, a controlled-release tablet containing tianeptine oxalate and naloxone. This patent grants market exclusivity until December 28, 2037, supporting the development of TNX-601 CR for treating major depressive disorder and PTSD. The formulation is designed for once-daily dosing, enhancing patient adherence compared to existing products. The patent signifies a major advancement in Tonix's proprietary drug development efforts.