Phase II
BMO Capital Markets analyst Evan Seigerman said luvadaxistat’s inconsistencies between mid-stage trials raise questions about Neurocrine Biosciences’ developmental efforts moving forward.
Without revealing specific details, GSK announced that it is terminating the development of its investigational herpes simplex virus vaccine after failing to meet the study’s primary efficacy objective.
Phase I data for TERN-601 suggests Terns’ oral GLP-1 candidate for obesity could be a contender in the market next to big names like Lilly, Pfizer and Roche.
Set to start in 2025, Relay Therapeutics is moving toward a pivotal study of experimental treatment RLY-2608 in heavily pretreated locally advanced or metastatic breast cancer.
Roche’s fenebrutinib this week scored a mid-stage win in relapsing multiple sclerosis, while Sanofi’s tolebrutinib met the primary endpoint in a Phase III trial for progressive MS but flopped in two late-stage relapsing MS studies.
Days after Sanofi reported back-to-back failures for its BTK inhibitor, Roche’s fenebrutinib on Wednesday scored a mid-stage win in relapsing multiple sclerosis, demonstrating near-total elimination of disease activity.
The investigational injection fosgonimeton appeared to have better efficacy in patients with more severe disease, according to post-hoc subgroup analyses, though none resulted in statistically significant effects.
Recursion’s oral drug candidate for cerebral cavernous malformation showed no improvements in patient- or physician-reported outcomes at 12 months. The biotech will engage with the FDA to determine the need for an additional study.
The highly anticipated results come as the company makes significant changes to its C-suite. Despite the turnover, Dyne said it is looking toward expedited approval pathways for its DMD treatment.
NuCana’s chemotherapy replacement has failed to improve progression-free survival in a Phase II test, sending the biotech’s shares down by 50%.
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