Tonix Pharmaceut Stock Price, News & Analysis

Tonix Pharmaceuticals (Nasdaq: TNXP) reported Q2 2025 financial results and operational highlights, with key focus on their lead candidate TNX-102 SL for fibromyalgia, which has an FDA PDUFA date of August 15, 2025. The company reported $125.3 million in cash and cash equivalents as of June 30, 2025.

Q2 2025 financial results showed net product revenue of $2.0 million and a net loss of $28.3 million ($3.86 per share). The company's cash runway is expected to extend into Q3 2026, supported by recent equity offerings that raised $51.5 million in net proceeds.

Notable developments include the company's addition to the Russell 3000® and Russell 2000® Indexes, publication of positive Phase 3 RESILIENT trial results in Pain Medicine, and progress across their CNS and immunology pipeline, including TNX-1500 and TNX-801.

Tonix Pharmaceuticals (Nasdaq: TNXP) has launched the "Move Fibro Forward" campaign through its commercial subsidiary, Tonix Medicines, Inc. The initiative aims to raise awareness and provide support for individuals affected by fibromyalgia, a condition that has not seen new FDA-approved treatments in over 15 years.

The campaign represents Tonix's commitment to the fibromyalgia community, focusing on validating patient experiences and providing educational resources. The initiative is supported by the Fibromyalgia Association, emphasizing the importance of visibility and support for those affected by this debilitating condition.

Tonix Pharmaceuticals (Nasdaq: TNXP) presented new data on TNX-801, their mpox and smallpox vaccine candidate, at the Vaccine Congress 2025. The vaccine shows promising characteristics including up to 100,000-fold less virulence than traditional smallpox vaccines while providing robust protection. Key findings demonstrate that subcutaneous administration offers equivalent protection to traditional percutaneous delivery.

TNX-801 demonstrated strong binding and neutralizing antibody responses across multiple animal species, with macaques showing 100% survival against lethal mpox challenge without lesions. The vaccine provided protection lasting over 14 months in rabbit models. The company plans to advance TNX-801 to clinical trials using subcutaneous delivery, positioning it as a potential single-dose solution for mpox and smallpox prevention.

Tonix Pharmaceuticals (NASDAQ:TNXP) has published results from its Phase 3 RESILIENT trial of TNX-102 SL for fibromyalgia in Pain Medicine journal. The trial demonstrated statistically significant improvement in reducing fibromyalgia pain compared to placebo, with a 1.8-point reduction versus 1.2-point for placebo on the daily pain scale.

The study, involving 457 adults across 33 U.S. sites, showed significant improvements across all six key secondary endpoints. TNX-102 SL was generally well-tolerated, with mild side effects. The FDA's PDUFA decision date is set for August 15, 2025, and if approved, it would be the first new fibromyalgia treatment in over 15 years.

Tonix Pharmaceuticals (Nasdaq: TNXP) announced that Dr. Sina Bavari will present new data on TNX-801, their mpox and smallpox vaccine candidate, at the Vaccine Congress 2025 in Vienna, Austria. TNX-801 is a minimally replicative, attenuated live virus vaccine that has shown promising preclinical results, demonstrating protection against mpox and other orthopoxviruses after a single dose.

The presentation, scheduled for July 10th at 11:20am GMT+2, will highlight TNX-801's safety, immunogenicity, and efficacy findings. The vaccine has demonstrated durable protection and good tolerability in immunocompromised animals, with no evidence of spreading to blood or tissues even at high doses. TNX-801 also serves as a platform that can deliver multiple protective antigens against diverse viral pathogens.

Additionally, Tonix has a $34 million contract with the U.S. DoD's Defense Threat Reduction Agency for TNX-4200, a broad-spectrum antiviral agent.

Tonix Pharmaceuticals (NASDAQ:TNXP) has published positive preclinical data in Cancer Cell journal regarding mTNX-1700, their experimental cancer treatment. The study demonstrated that combining mTNX-1700 with anti-PD1 antibody therapy significantly improved survival rates and reduced metastases in gastric cancer animal models.

The research showed that mTNX-1700, a fusion protein combining murine trefoil factor-2 (mTFF2) and murine serum albumin (MSA), effectively reduces immunosuppressive neutrophils and enhances anti-tumor immune responses. The human version, TNX-1700, is currently in preclinical development for gastric and colorectal cancers.

Key findings revealed that the combination therapy successfully shrank primary tumors, reduced liver and lung metastases, and activated cancer-killing CD8+ T cells while limiting neutrophil-mediated immune evasion.

Tonix Pharmaceuticals (Nasdaq: TNXP) announced its inclusion in the broad-market Russell 3000® Index and small-cap Russell 2000® Index, effective June 30, 2025. This addition comes as part of the 2025 Russell indexes reconstitution, which captures the 4,000 largest US stocks based on market capitalization rankings as of April 30.

The company is currently awaiting an FDA decision on TNX-102 SL for fibromyalgia management, with a PDUFA date of August 15, 2025. The FDA has granted Fast Track designation for this candidate. Additionally, Tonix has secured a contract worth up to $34 million over five years with the U.S. DoD's Defense Threat Reduction Agency for TNX-4200, a broad-spectrum antiviral agent.

Tonix's commercial subsidiary, Tonix Medicines, currently markets Zembrace® SymTouch® and Tosymra® for acute migraine treatment. The company's development portfolio includes various candidates targeting CNS disorders, immunology, and infectious diseases, with a state-of-the-art infectious disease research facility in Frederick, Md.

Tonix Pharmaceuticals presented data at EULAR 2025 for TNX-102 SL, their novel sublingual cyclobenzaprine formulation for fibromyalgia treatment. The drug demonstrated statistically significant pain reduction in two Phase 3 studies, with a FDA PDUFA date set for August 15, 2025. TNX-102 SL is designed for bedtime dosing and transmucosal delivery, showing durable activity over 14 weeks. The drug maintains higher cyclobenzaprine levels during sleep compared to norcyclobenzaprine, unlike oral formulations. If approved, TNX-102 SL would be the first new fibromyalgia treatment in 15 years and the first in a new class of non-opioid analgesics, potentially offering an alternative to addictive opioids currently prescribed for chronic pain.

Tonix Pharmaceuticals (NASDAQ: TNXP) has appointed James "Jim" Hunter to its Board of Directors, effective June 12, 2025. Hunter, who previously served as Executive Vice President of Commercial at Tonix, brings over 40 years of biopharmaceutical industry experience. His appointment comes at a crucial time as Tonix prepares for the potential launch of TNX-102 SL for fibromyalgia, with a PDUFA date of August 15, 2025. Hunter was instrumental in building Tonix Medicines and executing the company's entry into the migraine market. His experience includes leadership roles at Validus Pharmaceuticals, where he managed over two dozen product acquisitions, and Novartis Pharmaceuticals, where he led neuroscience sales. The appointment strengthens Tonix's commercial strategy as they expand their commercial footprint and prepare for the potential fibromyalgia drug launch.