A top-line Alzheimer's trial readout, once expected to catalyze value for the Vtv Therapeutics Inc. candidate azeliragon this year, instead hurried a 22.6% decline in company shares (NASDAQ:VTVT) to $2.30 after the phase II study found the drug yet again failed to deliver a statistically significant difference in cognitive decline vs. a placebo in people with mild probable Alzheimer’s disease (AD) and type 2 diabetes (T2D).
Positive results from the triple-combination arm of Biolinerx Ltd.’s phase IIa study of motixafortide as a combination therapy in incredibly tough-to-handle stage IV pancreatic cancer point toward a next study, yet the stock took a battering.
DUBLIN – Could a tyrosine kinase inhibitor approved for treating canine cancer offer clinical benefits in Alzheimer’s disease? That’s the bold claim AB Science SA is making, after unveiling top-line data from a phase IIb/III trial in which it reported that a subgroup of patients on a twice daily 4.5-mg/kg dose of oral masitinib experienced “a significant treatment effect” as compared with placebo after 24 weeks.
HONG KONG – Shanghai Junshi Biosciences Co. Ltd.’s toripalimab has reached its prespecified primary endpoint of progression-free survival at the interim analysis of a phase III study in non-small-cell lung cancer (NSCLC), as efforts to expand approval of the anti-PD-1 antibody into other cancer types are underway.
PERTH, Australia – Stem cell therapy company Mesoblast Ltd. saw its stock drop 15% on the news that its allogeneic mesenchymal cell therapy, rexlemestrocel-L (Revascor), failed to meet the primary endpoint of a reduction in hospitalizations in its phase III advanced chronic heart failure trial.
Three months after completing what it said was the largest development and commercialization deal by a Chinese biotech, I-Mab Biopharma Co. Ltd. is moving the monoclonal antibody at the heart of the deal deeper into the clinic. At the end of November, Chinese regulators gave it a green light to move forward with an open-label, multicenter trial for lemzoparlimab, in combination with azacitidine.
LONDON – The U.K. Medicines and Healthcare products Agency (MHRA) has given approval for the first-in-human study of Codagenix Inc.’s COVI-VAC, a live, attenuated whole virus COVID-19 vaccine, which is engineered to be structurally identical to wild-type SARS-CoV-2, but is much slower to replicate.
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