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The combined company will be guided by Santersus Chief Executive Officer James Ladtkow and will carry forward a four-program clinical portfolio centered on neutrophil extracellular traps, or NETs. The pipeline is headlined by two candidates that hold FDA Breakthrough Device designation in pivotal-phase development …
The clinical program is structured in two stages. An initial single-arm Phase 2a cohort will assess safety, followed by a randomized Phase 2b stage evaluating therapeutic efficacy. If NV-387 advances through this pathway, NanoViricides (NYSE: NNVC) said it would represent the only oral therapeutic …
Extended monitoring of the TRUST-I study population revealed no novel safety concerns and required no modifications to the existing safety labeling for IBTROZI, according to Nuvation Bio (NYSE: NUVB).
The Australian program builds on earlier progress, including the enrollment of the trial's first patient and a Type B meeting request submitted to the FDA to advance the U.S. regulatory pathway for ONP-002. Oragenics (NYSE American: OGEN) has said it plans to submit an …
The company is targeting clinical trial startup in the fourth quarter of 2026, alongside a pre-BLA Type B discussion with the FDA scheduled for late 2026. OS Therapies (NYSE: OSTX) said the program is supported by leadership from the UK's MHRA within Project Orbis, …
The upcoming presentation follows earlier Phase 1/2 topline results in which ABCL635 met its primary efficacy endpoints, achieving statistically significant reductions in both the frequency and severity of vasomotor symptoms at week four compared with placebo, after just a single dose. AbCellera Biologics (Nasdaq: …
Under the terms of the deal, existing North Immunology investors will hold approximately 95.25% of the combined company, while Aethlon Medical (Nasdaq: AEMD) shareholders will retain 4.75%, alongside a contingent value right tied to Aethlon's existing Hemopurifier technology. The financing is intended to provide …
When ART27.13 was combined with semaglutide, the two therapies together achieved roughly 40% total weight reduction. The effect was primarily concentrated in fat mass, with no impact on weight observed in lean control groups, according to Artelo Biosciences (Nasdaq: ARTL). The company said the …
The data come with a favorable tolerability profile and FDA Fast Track designation already in hand. BH-30643 is being developed for patients who have progressed on third-generation EGFR inhibitors and developed C797S resistance mutations, a setting where no approved targeted therapies currently exist. BlossomHill …
The downgrade follows Cellectis's (Nasdaq: CLLS) decision to discontinue its clinical CAR-T cell therapy portfolio and redirect resources toward early-stage in vivo gene editing. The shift represents a significant strategic reset for a company that had built its identity around allogeneic CAR-T development.
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