Phase 3
Argenx shares have fallen more than 13% after the surprise futility finding, which overshadowed a mid-stage celiac disease win for a separate asset acquired in the company’s $2.2 billion Forte Biosciences buy.
After one patient death prompted an FDA hold this spring, Newron Pharmaceuticals has now shared that a total of four fatalities have been recorded among participants receiving its schizophrenia candidate. A fifth death was recorded among those taking the placebo.
The Takeda spinout showed that a high dose of solengepras can shorten the periods during which difficult Parkinson’s disease symptoms like involuntary movements and sleepiness.
ArriVent BioPharma’s Phase 3 lung cancer trial was clouded by stronger-than-expected data for patients receiving chemotherapy, prompting analysts to pivot focus to a late-stage test of the tyrosine kinase inhibitor in a different type of lung cancer and to the biotech’s antibody-drug conjugate pipeline.
AbbVie and Genmab’s bispecific antibody blew analyst expectations out of the water with a 51% improvement in progression-free survival when used alongside a standard frontline regimen in diffuse large B cell lymphoma—potentially setting up a battle with Roche’s Polivy.
VAX-31 beat Pfizer and Merck’s established pneumococcal conjugate vaccines in a Phase 3 trial, exceeding investors’ most ambitious scenario and setting Vaxcyte up to challenge the Big Pharmas in a market worth $8 billion.
Bristol Myers Squibb will soon release Phase 3 data for admilparant that could make or break Contineum Therapeutics’ rival product. But reports of a death due to liver injury in the pharma’s program have caused some unease about the drug class.
Amid rising industry concerns about U.S. competitiveness with China, the Trump administration is rolling out four ARPA-H initiatives to modernize clinical trial design, site activation, consent and patient data collection.
The all-stock deal gives Summit Therapeutics enough money to see through Phase 3 trials for the PD-1/VEGF bispecific ivonescimab—but keeps the asset fully in-house without giving up licensing rights.
Kodiak Sciences will head to regulators with one of the candidates, an anti-VEGF antibody called zenkuda, after the late-stage results.
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