Tonix Pharmaceuticals Holding Corp. - TNXP STOCK NEWS

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.

Tonix Pharmaceuticals announced promising preliminary results for its COVID-19 vaccine candidate TNX-1800 in non-human primates. In a study, all eight vaccinated animals had no detectable SARS-CoV-2 in their airways after being challenged. TNX-1800, based on a horsepox vector, aims to provide long-term T cell immunity. Vaccination results indicated strong neutralizing antibody response and confirmed the 'take' as a biomarker for immunity. The company plans to advance TNX-1800 to human Phase 1 trials in late 2021, following FDA clearance and production of GMP-quality material.

Tonix Pharmaceuticals (Nasdaq: TNXP) announced positive interim results from its Phase 3 RELIEF Study for TNX-102 SL in fibromyalgia, achieving significant pain reduction (p=0.01). The company also reported a cash and equivalents balance of $77.1 million as of December 31, 2020, up from $11.2 million in 2019. Additional clinical advancements include the anticipated Phase 1 study for COVID-19 vaccine candidate TNX-1800 and the ongoing RALLY trial. The net loss for 2020 was $52.2 million, with substantial increases in R&D expenses linked to ongoing studies.

Tonix Pharmaceuticals (Nasdaq: TNXP) announced that 50% of participants have been randomized in its Phase 3 RALLY study for TNX-102 SL, aimed at managing fibromyalgia. The interim analysis of the initial participants is expected in Q3 2021, with topline results anticipated in Q4 2021. Following positive RELIEF study results, which showed significant pain reduction, Tonix aims to submit a New Drug Application (NDA) for TNX-102 SL to the FDA in 2022 if RALLY results are favorable.

Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announces its participation in three upcoming virtual investor conferences. Seth Lederman, M.D., the Company's CEO, will present at the 33rd Annual ROTH Conference on March 16, 2021, followed by the Maxim Emerging Growth Conference on March 17-18, 2021, where a presentation will be available on demand. The Investor Summit will occur from March 23-25, 2021, with Tonix's presentation scheduled for March 23 at 10:30 a.m. ET. Webcasts will be accessible on the Company's website.

On March 3, 2021, Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced it has regained compliance with Nasdaq's minimum bid price requirement. The company confirmed its shares closed above $1.00 for 20 consecutive business days, satisfying the listing criteria. Tonix focuses on developing treatments for CNS and immunology conditions, with its lead candidate TNX-102 SL in mid-Phase 3 trials for fibromyalgia. The company expects interim data from another Phase 3 trial, RALLY, in Q3 2021, and efficacy data for its COVID-19 vaccine candidate, TNX-1800, in Q1 2021.

Tonix Pharmaceuticals (Nasdaq: TNXP) has licensed technology from Inserm for oxytocin-based treatments targeting Prader-Willi syndrome and non-organic failure to thrive. The co-exclusive license expands Tonix's intranasal potentiated oxytocin program with the new candidate TNX-2900. This technology is projected to provide market exclusivity until 2031 across the U.S. and Europe. Prader-Willi syndrome, affecting approximately 1 in 15,000 births, lacks approved treatments. Tonix aims to pursue FDA Orphan Drug and Fast Track designations for TNX-2900, addressing the disorder's critical health challenges.