BioXcel Therapeutics (ticker: BTAI) announced positive feedback from the FDA following a pre-submission New Drug Application (pre-sNDA) meeting regarding BXCL501, a treatment for agitation associated with bipolar disorders or schizophrenia. The company's stock surged by approximately 27% in pre-market trading after the announcement. Subsequently, BioXcel completed the database lock for its SERENITY At-Home pivotal Phase 3 safety trial evaluating BXCL501 for acute agitation in patients with bipolar disorder or schizophrenia. The topline results from this trial are expected in August 2025. This trial addresses a notable unmet medical need, as there are currently no FDA-approved at-home treatments for agitation in these conditions. Additionally, other biotechnology companies announced developments including BioNxt receiving fast-track status for a multiple sclerosis drug and Envoy Medical securing new patents in implantable hearing technology. NovaBay experienced a 75% pre-market stock increase following a $6 million investment and appointment of a new CEO.