Certa Plans Pivotal Scleroderma Trial As GPCR Antagonist Hits Phase II Bullseye
Australian Firm Has High Hopes
Certa’s lead candidate has shown promise in a mid-stage trial for the rare but debilitating skin disorder, triggering pivotal development plans to address the high unmet need.
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The blockbuster drug is expected to see overall sales declines in the next few years, and biosimilar competition could come as soon as 2023.
Part One Disappointment For BioXcel’s Igalmi In Pivotal Agitation Trial
The US firm’s drug for schizophrenia- and bipolar-related agitation Igalmi has failed part one of a pivotal trial in at-home patients, but the option for higher dosing in part two combined with placebo-like safety could offer hope.
Mirati’s Pivotal NSCLC Disappointment For Sitravatinib Combo ‘Unsurprising’
The US firm’s kinase inhibitor fell short of overall survival expectations in combination with a PD-1 inhibitor in an advanced lung cancer trial, but upcoming milestones for Krazati may be more of a concern.