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EMERGENT

USupdated 6mo ago
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News

  • Compass to submit psilocybin depression drug for approval imminently after stock wobbles
    Compass Pathways revealed that an FDA filing for COMP360 will be complete “in the next two weeks,” with an expected drug launch in the first half of next year. The update follows a reported regulat…
    biospace · 3h ago
  • Tiziana touts multiple sclerosis win at lower dose as high dose misses mark
    In a mid-stage trial, the lower dose of Tiziana’s intranasal monoclonal antibody reduced microglial activation in a specific type of multiple sclerosis. But the path forward remains unclear after t…
    biospace · 1d ago
  • Lower dose of Tiziana's MS drug reduces neuroinflammation, while higher dose struggles
    Tiziana Life Sciences’ intranasal drug has hit the dual endpoints of a phase 2a study in patients with a form of multiple sclerosis (MS), although the win was slightly marred by the higher dose mis…
    fiercebiotech · 1d ago
  • ESMO 2026: Amgen’s Imdelltra slashes death risk by nearly 60% in small cell lung cancer
    When used alongside AstraZeneca’s Imfinzi, the bispecific T cell engager Imdelltra extended survival by eight months versus Imfinzi alone in Phase 3 study testing the combo in a first-line maintena…
    biospace · 8d ago
  • ESMO: Takeda’s $1.2B bet on Innovent ‘absolutely’ pays off with details of ADC’s phase 3 win
    Takeda has lifted the lid on the phase 3 win for its next-generation claudin18.2 drug, with the antibody-drug conjugate (ADC) demonstrating overall survival of 10.2 months.
    fiercebiotech · 11d ago
  • Rapport’s epilepsy drug finds surprising success in bipolar trial
    Despite what some analysts described as low expectations, RAP-219 narrowly hit the main goal of a mid-stage study, results that could help it tap a billion-dollar-plus market opportunity.
    biopharma_dive · 14d ago
  • Rapport ekes out bipolar mania win as lead asset ‘just hits’ in mid-stage trial
    Rapport Therapeutics clocked its second Phase 2 win in 14 months for RAP-219—which the company is positioning as a potential pipeline-in-a-product—this time showing improvement in symptoms of bipol…
    biospace · 14d ago
  • Disc’s rebuffed rare blood disease drug sets up FDA re-do after ‘clean’ Phase 3 sweep
    Disc Medicine’s bitopertin—rejected by the FDA in February—significantly reduced levels of a key disease biomarker and significantly increased the time patients with erythropoietic protoporphyria w…
    biospace · 15d ago
  • Disc’s rebuffed rare disease drug sets up FDA redo after ‘clean’ Phase 3 sweep
    Disc Medicine’s bitopertin—rejected by the FDA in February—significantly reduced levels of a key disease biomarker and significantly increased the time patients with erythropoietic protoporphyria w…
    biospace · 15d ago
  • Disc spins past FDA rejection with ‘overwhelmingly positive’ phase 3 data for rare disease drug
    A phase 3 trial of Disc Medicine’s bitopertin has hit both co-primary endpoints and all secondary endpoints, positioning the biotech to refile for approval of the once-rejected rare disease drug ca…
    fiercebiotech · 15d ago
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