Topline results from the Phase III TULIP study show an antibody-drug conjugate (ADC) from the Netherlands-based Byondis B.V. significantly prolonged progression-free survival (PFS) in patients with pretreated HER2-positive unresectable locally advanced or metastatic breast cancer (MBC).
Novartis announced Phase II primary endpoint data showing the investigational, first-in-class, oral, targeted factor B inhibitor iptacopan reduced protein in the urine – an increasingly recognized surrogate marker correlating with progression to kidney failure – and showed promise in stabilizing kidney function in patients with IgA nephropathy (IgAN).
NGM Biopharmaceuticals’ aldafermin failed to hit the primary endpoint in the company’s Phase IIb ALPINE 2/3 trial for non-alcoholic steatohepatitis (NASH) with stage 2 or 3 liver fibrosis.
Eli Lilly released the company’s first-quarter 2021 financial report and is abandoning plans to submit mirikizumab to health regulators for psoriasis.
Regeneron Pharmaceuticals announced results from the company’s Phase III trial of recently infected asymptomatic Covid-19 patients for the REGEN-COV (casirivimab with imdevimab) antibody cocktail.
AstraZeneca’s diabetes drug Farxiga (dapagliflozin) failed to reach endpoints in a Phase III study as a potential treatment for hospitalized Covid-19 patients at serious risk of developing complications.
The U.S. Food and Drug Administration issued a Complete Response Letter (CRL) over Acadia Pharmaceuticals’ supplemental New Drug Application (sNDA) for Nuplazid for hallucinations and delusions associated with dementia-related psychosis.
A readout from a Phase IIb/III trial showed intravenous RLF-100 (aviptadil) met the primary endpoint of improving survival and recovery at 60 days post-treatment for respiratory failure in critically ill patients with Covid-19, bolstering the case for sponsors NeuroRx and Relief Therapeutics to reapply for emergency use authorization (EUA).
Copenhagen, Denmark-based Orphazyme announced the company’s Phase II/III clinical trial of arimoclomal for inclusion body myositis (IBM) failed to hit primary and secondary endpoints.
Genentech reported that the company’s rheumatoid arthritis drug Actemra failed to hit the primary endpoint in a Covid-19 trial, while Vir and GlaxoSmithKline’s antibody against Covid-19 demonstrated 85 percent efficacy.