Soligenix (Nasdaq: SNGX), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for a Phase 2a clinical trial entitled, "Pilot Study of SGX945 (Dusquetide) in the Treatment of Aphthous Ulcers in Behçet's Disease." The study is designed to evaluate the safety and efficacy of SGX945 (dusquetide) and is expected to begin patient enrollment in the second half of 2024.

bioAffinity Technologies (Nasdaq: BIAF), a biotechnology company addressing the need for noninvasive detection of early-stage lung cancer and other lung diseases, announced that the Centers for Medicare and Medicaid Services (CMS) has made a final determination for payment for CyPath® Lung, a noninvasive test for early-stage lung cancer, for the 2024 calendar year. “CyPath® Lung, our noninvasive test for the detection of early-stage lung cancer, is now on CMS’ 2024 clinical laboratory fee schedule, a major milestone that facilitates reimbursement by both Medicare and private payers, which in turn should make our test even more attractive to both physicians and their patients at high risk for lung cancer,” bioAffinity Technologies President and CEO Maria Zannes said. “The CMS payment determination is an important achievement in our strategic plan to ramp up the commercialization of CyPath® Lung.”

ASP Isotopes (Nasdaq: ASPI), an advanced materials company dedicated to the development of technology and processes for the production of isotopes for use in multiple industries, announced that it has signed a memorandum of understanding with a second US-based SMR (Small Modular Reactor) company to establish a facility for producing High Assay Low Enriched Uranium (HALEU), a critical fuel for next-generation nuclear reactors. The Company has received interest from potential customers totaling over $30 billion(1) of HALEU demand at recent market prices.

BioVie (Nasdaq: BIVI), a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease, announced positive analysis of unblinded, topline efficacy data from its Phase 3 clinical trial (NCT04669028) of NE3107 in the treatment of mild to moderate Alzheimer’s Disease (AD). Data from evaluable patients show NE3107’s treatment advantage compared to placebo may be equal to or greater than the benefit from approved AD monoclonal antibodies. NE3107-treated patients also experienced a 4.66-year advantage in age deceleration vs. placebo as measured by epigenetics/DNA methylation Skin Blood Clock.