Clinical research
The major depressive disorder failure for BHV-7000 is the drug’s second, after Biohaven’s spinocerebellar ataxia treatment troriluzole was rejected by the FDA in November 2025.
With a pair of Phase III trial flops, Ultragenyx will explore cost reductions as analysts turn attention to an upcoming Angelman syndrome readout.
Analysts said the outcome is disappointing because there are no approved treatments for dyskinetic cerebral palsy, but the setback had little impact on Neurocrine’s valuation.
The patient, who died on December 14, was originally enrolled in a Phase III study in 2022 and transitioned into an extension phase in 2023.
Ceralasertib is part of AstraZeneca’s ambitious plan to hit $80 billion in revenue by 2030.
Jacobio discovered JAB-23E73, which is designed to treat several KRAS mutation subtypes, and is testing the therapy in multiple Phase I trials.
Insmed pointed to a strong placebo response as the reason for the trial’s failure.
The fatalities were attributed to interstitial lung disease, a known side effect of Daiichi Sankyo’s DXd-based antibody-drug conjugates. A spokesperson declined to say how many patients died.
With zasocitinib, Takeda is looking to challenge Bristol Myers Squibb’s kinase inhibitor Sotyktu, for which the Japanese pharma is running a head-to-head study in plaque psoriasis. Takeda expects to file for zasocitinib’s FDA approval next year.
Participants in a Phase III trial who switched to Eli Lilly’s orforglipron after 72 weeks of treatment with Wegovy or Zepbound largely maintained their weight loss for up to a year.
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