Tonix Pharmaceut Stock Price, News & Analysis

Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced the acceptance of an oral presentation at the ACR Convergence 2021, scheduled for November 6, 2021. The presentation will focus on TNX-102 SL, highlighting positive results from a Phase 3 trial for fibromyalgia treatment. The company's pipeline also includes candidates for COVID-19, such as TNX-1800, slated for Phase 1 studies in early 2022, and TNX-3500, which is in pre-IND development. Tonix aims to address various health challenges, particularly in immunology and CNS disorders.

Tonix Pharmaceuticals (Nasdaq: TNXP) has expanded its collaboration with Columbia University to study immune responses to COVID-19. This research targets healthy volunteers with previous infections or those asymptomatic, focusing on T cell and antibody responses. Principal investigators Dr. Ilya Trakht and Dr. Sergei Rudchenko aim to identify biomarkers for protective immunity, potentially leading to tailored vaccines and monoclonal antibody therapeutics. Tonix's lead vaccine candidate, TNX-1800, is advancing toward a Phase 1 study, expected to begin in early 2022.

Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced that its President and CEO, Seth Lederman, will present at the 2021 Cantor Virtual Global Healthcare Conference on September 28, 2021, at 2:00 p.m. ET. Investors can arrange virtual meetings with the management. A webcast of the presentation will be accessible on the Tonix website under the Investors section, with a replay available for 90 days. Tonix focuses on developing treatments for various conditions, including COVID-19, utilizing a platform of innovative product candidates.

Tonix Pharmaceuticals (Nasdaq: TNXP) announced progress on its live virus vaccine TNX-1800, designed to provide long-lasting T cell immunity against COVID-19. Following a pre-IND meeting with the FDA, the company received guidance on the Phase 1 study, expected to commence in H1 2022. TNX-1800 demonstrated efficacy in animal studies, effectively protecting upper and lower airways from SARS-CoV-2. The vaccine, based on horsepox, may offer advantages like scalability and reduced cold chain requirements compared to existing mRNA vaccines.

Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced that its President and CEO, Seth Lederman, will present at the H.C. Wainwright 23rd Annual Global Investment Conference from September 13-15, 2021. Interested investors may arrange virtual meetings with management. A webcast of the presentation will be available on-demand starting September 13, 2021, at 7:00 a.m. on the Tonix website, with a replay accessible for 90 days. Tonix focuses on developing therapies in CNS and immunology, including lead candidates for fibromyalgia and COVID-19 vaccines.

Tonix Pharmaceuticals (Nasdaq: TNXP) announced plans to submit an Investigational New Drug (IND) application in Q4 2021 for TNX-102 SL as a treatment for Long COVID, focusing on patients with symptoms overlapping fibromyalgia. The FDA has provided guidance on the Phase 2 study design following a Type B pre-IND meeting. Long COVID affects over 30% of COVID-19 patients and can lead to persistent symptoms such as fatigue and pain. The company aims to leverage insights from its mid-Phase 3 fibromyalgia trials to inform this new treatment approach.

Tonix Pharmaceuticals (Nasdaq: TNXP) reported its Q2 2021 financial results, highlighting ongoing clinical trials for TNX-1300 and TNX-1900, and a Phase 3 study for TNX-102 SL. The company aims to enhance R&D and manufacturing capabilities with new facilities and expects a cash balance of approximately $166 million as of June 30, 2021. Research and development expenses rose to $18.1 million, while the net loss was $23.6 million, or $0.07 per share. The company’s focus includes advancing COVID-19 product candidates and expanding its CNS pipeline.

Tonix Pharmaceuticals announced a groundbreaking ceremony for its new Advanced Development Center (ADC) in New Bedford, MA, scheduled for August 3, 2021. The 45,000 sq. ft. facility will enhance the company's capacity for vaccine development, focusing on infectious diseases, including COVID-19. It aims to be operational in the first half of 2022 and will employ up to 70 staff. The ADC will support clinical manufacturing under Good Manufacturing Practices (GMP) and is a significant step toward addressing public health challenges.

Tonix Pharmaceuticals (Nasdaq: TNXP) announced the acquisition of a 48,000 square foot R&D facility in Frederick, MD, from Southern Research. This facility will expand Tonix's capabilities in developing vaccines and antiviral drugs, specifically against COVID-19 and other infectious diseases. The acquisition aims to enhance the production and efficiency of Tonix’s vaccine candidates, including TNX-1800 and TNX-801. Expected to close by Q4 2021, this strategic move addresses challenges revealed by the COVID-19 pandemic and positions Tonix within Maryland’s biotech corridor.