Corestemchemon Inc. is planning to file a BLA for Neuronata-R (lenzumestrocel) by the end of 2025 to gain accelerated approval from the U.S. FDA, company officials confirmed to BioWorld during a June 2 interview. Neuronata-R is an autologous bone marrow-derived mesenchymal stem cell therapy that first gained approval in South Korea in 2014 to delay the progression of amyotrophic lateral sclerosis (ALS), a progressive neurodegenerative disorder also known as Lou Gehrig’s disease.
Researchers at the Massachusetts Institute of Technology and Recursion Pharmaceuticals Inc. have released an open-source AI model that can predict the binding strength of small molecules as well as structures of proteins and biomolecular complexes. The model, which is called Boltz-2 and was released by the research team on the developer platform Github on June 6, addresses a major bottleneck in drug discovery with its improved ability to predict binding strengths.
One of the big questions going into the phase I readout for Metsera Inc.’s amylin analogue, MET-233i, was whether findings would support once-monthly dosing for the potential obesity candidate. They did. Results also indicated solid and dose-dependent weight loss activity, and Metsera was able to identify well-tolerated starting doses for subsequent studies, said Steve Marso, chief medical officer. “So we exceeded expectations on all three scientific objectives.”
In two phase III studies, Merck & Co. Inc.’s oral, once monthly proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor produced statistically significant and clinically meaningful cuts in low-density lipoprotein cholesterol levels. The PCSK9 inhibitor is looking to fit into a crowded market that already has well-established therapies from other big pharmas and a potential competitor in development to treat another indication.
Microneedle technology could help simplify vaccine delivery to better support global immunization efforts, and Australia is leading the way in this innovative technology.
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