fda-and-biotech News

Cidara Therapeutics Stock Soars on Clinical Trial Progress
FDA & Biotech
2mo ago

Cidara Therapeutics Stock Soars on Clinical Trial Progress

Shares in the biotech firm jumped after announcing full enrollment in a pivotal Phase 3 trial for its lead drug candidate, rezafungin.

Acrivon Shares Gyrate After Positive Cancer Drug Data and Q3 Beat
FDA & Biotech
2mo ago

Acrivon Shares Gyrate After Positive Cancer Drug Data and Q3 Beat

Initial optimism from promising Phase 1 trial results and a narrower loss fades as the clinical-stage biotech's stock reverses early gains.

Omeros Beats Q3 Estimates, Touts $2.1B Novo Nordisk Deal
FDA & Biotech
2mo ago

Omeros Beats Q3 Estimates, Touts $2.1B Novo Nordisk Deal

Company secures major cash injection ahead of a critical FDA decision for its lead drug, narsoplimab, though shares dip in late trading.

Sera Prognostics Stock Dips Despite Strong Cash Runway to 2028
FDA & Biotech
2mo ago

Sera Prognostics Stock Dips Despite Strong Cash Runway to 2028

Investors weigh a Q3 revenue miss against an earnings beat and the promise of pivotal data from the company's preterm birth study.

Reviva Shares Jump as Losses Narrow, Positive Drug Data Emerges
FDA & Biotech
2mo ago

Reviva Shares Jump as Losses Narrow, Positive Drug Data Emerges

The company reported a significantly smaller Q3 loss and positive one-year results for its lead schizophrenia drug, setting the stage for a key FDA meeting in Q4.

Senti Bio Stock Slides as Cash Reserves Dwindle, Solvency Concerns Mount
FDA & Biotech
2mo ago

Senti Bio Stock Slides as Cash Reserves Dwindle, Solvency Concerns Mount

The biotech firm's Q3 loss widened with zero revenue, placing intense pressure on upcoming clinical data for its lead drug candidate.

Anebulo Hits Key Milestone, Doses First Subjects in Selonabant Trial
FDA & Biotech
2mo ago

Anebulo Hits Key Milestone, Doses First Subjects in Selonabant Trial

Clinical-stage biotech also posts a narrower-than-expected Q1 loss, signaling disciplined execution as it advances its lead drug for acute cannabis toxicity.

Vistagen Eyes Year-End Data for Key Social Anxiety Drug Trial
FDA & Biotech
2mo ago

Vistagen Eyes Year-End Data for Key Social Anxiety Drug Trial

Company completes enrollment for its pivotal PALISADE-3 study for fasedienol nasal spray, a crucial catalyst following a mixed quarterly report.