Talphera
NASDAQ:TLPHTalphera, Inc., a specialty pharmaceutical company, focuses on the development and commercialization of therapies for use in medically supervised settings. Its lead product candidate is Niyad, a lyophilized formulation of nafamostat, which is under an investigational device exemption as an anticoagulant for the extracorporeal circuit. It is also developing LTX-608, an anti-inflammatory and antiviral potential for the treatment of multiple conditions, including disseminated intravascular coagulation (DIC), acute respiratory distress syndrome (ARDS), and acute pancreatitis; Fedsyra, a pre-filled ephedrine syringe; and PFS-02, a pre-filled phenylephrine syringe. The company was formerly known as AcelRx Pharmaceuticals, Inc. and changed its name to Talphera, Inc. in January 2024. The company was incorporated in 2005 and is headquartered in San Mateo, California.
Tonix Pharmaceuticals
NASDAQ:TNXPTonix Pharmaceuticals Holding Corp., a biopharmaceutical company, focuses on developing, discovering, commercializing, and licensing therapeutics to treat and prevent human disease and alleviate suffering. It markets Zembrace SymTouch and Tosymra for the treatment of acute migraine with or without aura in adults. Its portfolio focuses on central nervous system disorders, as well as rare disease, immunology, and infectious disease product candidates. The company's priority is to submit a New Drug Application (NDA) to the FDA for TNX-102 SL (cyclobenzaprine HCl sublingual tablet), which has completed two positive Phase 3 studies for the management of fibromyalgia. TNX-102 SL is also being developed to treat fibromyalgia-type Long COVID, a chronic post-acute COVID-19 condition. Its TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted breakthrough therapy designation by the FDA. The company's rare disease development portfolio comprises TNX-2900, an intranasal potentiated oxytocin for the treatment of Prader-Willi syndrome (PWS). Its immunology portfolio includes TNX-1500, which is a biologic to address organ transplant rejection and autoimmune diseases. The company's infectious disease pipeline includes TNX-801, a vaccine in development to prevent smallpox and mpox. TNX-801 also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases, including TNX-1800 and TNX-1850, in development as a vaccine to protect against COVID-19. Its infectious disease development portfolio also comprises TNX-3900, and TNX-4200 are orally available CD45 antagonists in preclinical development. The company was founded in 2007 and is headquartered in Chatham, New Jersey.
Traws Pharma
NASDAQ:TRAWTraws Pharma, Inc., a clinical-stage biopharmaceutical company, focuses on discovering and developing novel products to treat cancer in the United States. It has two clinical-stage programs, including narazaciclib, a multi-targeted kinase inhibitor that is in Phase I study for solid tumors, as well as hematological malignancies as a single agent or in combination with other anti-cancer therapies; and oral rigosertib alone or in combination with PD-1 inhibitor, which is in Phase I/IIa study for patients with check point inhibitor (CPI) resistant K-Ras mutated non-small cell lung cancer. The company also conducting a Phase II investigator-initiated study with rigosertib monotherapy in patients with advanced/metastatic squamous cell carcinoma associated with recessive dystrophic epidermolysis bullosa. It has a license and collaboration agreement with HanX Biopharmaceuticals, Inc. for the development, registration, and commercialization of narazaciclib in China; with SymBio Pharmaceuticals Limited for the development and commercialization of rigosertib in Japan and Korea; and Pint License Agreement to develop and commercialize any pharmaceutical product containing rigosertib in all uses of rigosertib in humans in Latin American countries. The company was formerly known as Onconova Therapeutics, Inc. and changed its name to Traws Pharma, Inc. in April 2024. Traws Pharma, Inc. was incorporated in 1998 and is headquartered in Newtown, Pennsylvania.
Vaxxinity
NASDAQ:VAXXVaxxinity, Inc., a biotechnology company, focuses on developing product candidates for human use in the fields of neurology, cardiovascular diseases, and coronaviruses in the United States. The company engages in developing UB-311 that targets toxic forms of aggregated amyloid-b in the brain to fight Alzheimer's disease (AD) that is in phase 2 clinical trial; UB-312 that targets toxic forms of aggregated a-synuclein in the brain to fight Parkinson's disease and other synucleinopathies, such as Lewy body dementia and multiple system atrophy that is in phase 1 clinical trial; and VXX-301, an anti-tau product candidate for various neurodegenerative conditions, including AD. It is also developing UB-313 that targets calcitonin gene-related peptide to fight migraines; VXX-401 that targets proprotein convertase subtilisin/kexin type 9 serine protease to lower low-density lipoprotein cholesterol and reduce the risk of cardiac events; and UB-612 for neutralizing the SARS-CoV-2 virus, which is in phase 3 clinical trial. Vaxxinity, Inc. was founded in 2014 and is headquartered in Merritt Island, Florida.