Tonix Pharmaceuticals Holdings is a clinical-stage biopharmaceutical company focused on developing innovative therapies for central nervous system disorders and other serious medical conditions
The company is dedicated to advancing its pipeline of product candidates, which include treatments for conditions such as migraines, post-traumatic stress disorder, and various infectious diseases. By leveraging its expertise in drug development and utilizing strategic collaborations, Tonix aims to bring novel treatment options to market that address unmet medical needs and improve patient outcomes.
Shares of Tonix Pharmaceuticals are pulling back 12.7% during Thursday's session. The stock is pulling back following a regulatory update on its experimental fibromyalgia treatment, TNX-102 SL.
Tonix Pharmaceuticals (NASDAQ: TNXP), announced that CEO Seth Lederman, M.D., will present a poster at the AAPM 2025 Annual Meeting, PainConnect, in Austin, Texas. The presentation is scheduled for April 5 at 11:45 a.m. CT during the event, which runs from April 3–6. The company develops and markets biopharmaceutical products and is advancing a pipeline of clinical-stage candidates.
Two biotech companies have surged on recent developments, illustrating biotech's volatility and prompting investors to evaluate potential long-term value.
Tonix Pharmaceuticals (NASDAQ: TNXP), a biopharmaceutical company with marketed products and a robust development pipeline, announced that the FDA will not require an Advisory Committee meeting to evaluate its New Drug Application for TNX-102 SL, a potential new treatment for fibromyalgia. If approved, TNX-102 SL would be the first new fibromyalgia therapy in 15 years. The drug, which previously received Fast Track designation, could launch in the fourth quarter of 2025. TNX-102 SL targets central sensitization and aims to address widespread dissatisfaction with current treatments.
Tonix Pharmaceuticals shares are trading higher by 22.5% during Monday's session. The company announced that the FDA will not require an Advisory Committee meeting for its New Drug Application for TNX-102 SL.
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Tonix Pharmaceuticals (NASDAQ: TNXP), a biopharmaceutical company developing innovative vaccines, is advancing TNX-801, a live, minimally replicating recombinant virus vaccine designed to protect against mpox. The company reports that TNX-801 has demonstrated single-dose immunity and superior tolerability compared to 20th-century vaccinia vaccines in animal studies. As a new strain of mpox, Clade I, spreads globally—including recent cases in the U.S.—health officials are seeking more effective prevention methods. Tonix believes TNX-801 aligns with the World Health Organization’s criteria for durable, single-dose vaccines that can be administered without special equipment.
Clade I, the culprit in the current 2025 version of global epidemic mpox, is highly transmissible and is spreading within families and among children, whereas the 2022 Clade II mpox - still spreading - infects mostly gay men
Let's have a look at what is happening on the US markets in the middle of the day on Wednesday. Below you can find the top gainers and losers in today's session.
Tonix CEO Seth Lederman remains optimistic with the launch of a new drug for the management of pain in Fibromyalgia patients in the pipeline for the fourth quarter (Q4) of 2025.
Tonix Pharmaceuticals (NASDAQ: TNXP) announced its fourth-quarter and full-year 2024 financial results, alongside key operational updates. The company highlighted preparations for the potential commercial launch of TNX-102 SL for fibromyalgia in Q4 2025, pending FDA approval with a PDUFA date set for Aug. 15, 2025. Tonix remains debt-free, with cash resources projected to support operations into early 2026. The company also reported progress across its pipeline, including TNX-1500 for kidney transplant rejection, TNX-801 for mpox and smallpox, and TNX-1300 for cocaine intoxication. For Q4 2024, net product revenue reached $2.6 million, while the company reported a net loss of $22.1 million. Full-year 2024 net loss was $130 million, with R&D expenses reduced to $40 million from $86.7 million in 2023 due to pipeline prioritization.
Let's have a look at what is happening on the US markets after the closing bell on Tuesday. Below you can find the top gainers and losers in today's after hours session.
Tonix Pharmaceuticals (NASDAQ: TNXP), a fully integrated biopharmaceutical company, announced that CEO Seth Lederman, M.D., will present at the 2025 BIO-Europe Spring Convention on March 17 in Milan, Italy. The presentation will highlight TNX-102 SL, a sublingual cyclobenzaprine tablet for fibromyalgia management, which has a U.S. Food and Drug Administration PDUFA goal date of Aug. 15, 2025. If approved, TNX-102 SL would be the first new fibromyalgia treatment in 15 years.
