Tonix Pharmaceuticals Holding Corp. - TNXP STOCK NEWS

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.

Tonix Pharmaceuticals, a clinical-stage biopharmaceutical company, announced that its CEO, Seth Lederman, M.D., will participate in the BIO CEO & Investor Digital Conference from February 16-18, 2021. The presentation will be available on demand for registered participants and can later be accessed on the company's website. Tonix focuses on developing therapies for central nervous system and immunology conditions. Its lead candidate, TNX-102 SL, is in mid-Phase 3 trials for fibromyalgia, while TNX-1800 aims to provide protection against COVID-19.

Tonix Pharmaceuticals Holdings Corp. (NASDAQ: TNXP) announced the closing of a registered direct offering, generating approximately $70.0 million in gross proceeds before expenses. The company sold 58,333,334 shares of common stock at $1.20 per share, with A.G.P./Alliance Global Partners acting as the sole placement agent. The offering was conducted under effective shelf registration statements filed with the SEC. Tonix focuses on the development of therapies for CNS and immunology conditions, with several candidates in clinical stages, including TNX-102 SL for fibromyalgia and TNX-1800 for COVID-19.

Tonix Pharmaceuticals Holdings Corp. (NASDAQ: TNXP) announced a securities purchase agreement with institutional investors for the sale of 58,333,334 shares of common stock at $1.20 per share, totaling approximately $70 million in gross proceeds. The registered direct offering is expected to close around February 9, 2021, pending customary conditions. A.G.P./Alliance Global Partners acts as the sole placement agent. This offering is made under effective shelf registration statements filed with the SEC.

Tonix Pharmaceuticals (Nasdaq: TNXP) announced FDA guidance on its pre-investigational new drug (IND) meeting for TNX-2100, a diagnostic skin test to measure T cell immunity to SARS-CoV-2. This test aims to support COVID-19 diagnosis, public health surveillance, and vaccine trials. TNX-2100 utilizes three synthetic peptide mixtures to elicit a delayed-type hypersensitivity reaction, providing a cost-effective and timely method for assessing T cell responses. The company plans to file the IND application in Q2 2021 and begin clinical trials in H2 2021 pending FDA clearance.