Wednesday, December 18, 2024
Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics and diagnostics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of immunology, rare disease, infectious disease, and central nervous system (CNS) product candidates. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-15001 which is a humanized monoclonal antibody targeting CD40-ligand being developed for the prevention of allograft and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the second half of 2022. Tonix’s rare disease portfolio includes TNX-29002 for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan-Drug Designation by the FDA. Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox called TNX-8013, next-generation vaccines to prevent COVID-19, and an antiviral to treat COVID-19. Tonix’s lead vaccine candidates for COVID-19 are TNX-1840 and TNX-18504, which are live virus vaccines based on Tonix’s recombinant pox vaccine (RPV) platform. TNX-35005 (sangivamycin, i.v. solution) is a small molecule antiviral drug to treat acute COVID-19 and is in the pre-IND stage of development. TNX-102 SL6, (cyclobenzaprine HCl sublingual tablets), is a small molecule drug being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix expects to initiate a Phase 2 study in Long COVID in the second quarter of 2022. The Company’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL, is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study launched in the second quarter of 2022. Finally, TNX-13007 is a biologic designed to treat cocaine intoxication that is expected to start a Phase 2 trial in the second quarter of 2022. TNX-1300 has been granted Breakthrough Therapy Designation by the FDA.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
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New Drug Application For Tonmya Accepted For Review. Tonix announced that the FDA has accepted the filing of the Tonmya NDA, showing that the application met the requirements for a full review. Tonmya received Fast Track designation, and an application for Priority Review was filed. Next, notification of the assigned PDUFA date (the statutory date for completing a review under the Prescription Drug User Fee Act) and Priority Review status are expected in about 14 days.
We Believe Tonmya Can Have A Significant Impact On Fibromyalgia Treatment. Symptoms of fibromyalgia include chronic pain, insomnia, depression, brain fog, fatigue, and abdominal cramps with varying severity. This variety of physical and cognitive symptoms has been treated with a combination of pain medications, anti-depressants, insomnia drugs, and neurological drugs. Tonmya is the first drug that was developed for fibromyalgia. Its clinical trials showed strong statistical significance in its primary endpoint (pain reduction) and all six secondary endpoints. No other single drug has shown this broad effect on multiple fibromyalgia symptoms.
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