CAR-T
BMS and J&J will meet with the Oncologic Drugs Advisory Committee Friday to discuss their CAR-T therapies Abecma and Carvykti as the companies seek their approval as earlier lines of treatment.
The FDA’s busy week ahead involves three decision dates for potential industry firsts and a highly anticipated advisory committee meeting for two CAR-T therapies.
Cell and gene therapy professionals gathered in Miami last month to discuss new manufacturing approaches for these up-and-coming treatments.
Johnson & Johnson and Legend Biotech got a positive opinion from a European Medicines Agency panel for earlier lines of treatment, as they ready for a March FDA advisory committee meeting.
After treatment with a CD19 CAR-T therapy, patients with systemic lupus erythematosus, idiopathic inflammatory myositis or systemic sclerosis achieved long-lasting remission, according to results published in the NEJM.
Kelonia Therapeutics’ in vivo gene placement system is being tapped to help Astellas Pharma expand its portfolio of in vivo CAR-T cell therapies for cancer.
Investors drove up the price of Kyverna Therapeutics’ stock by 59% in its initial public offering on Thursday afternoon, the first day of trading, reaching a peak per-share price of $35.01.
BioNTech will pay $50 million in cash and purchase $200 million of Autolus Therapeutics’ shares to progress the companies’ respective CAR-T candidates to commercialization.
On Thursday, Kyverna Therapeutics is debuting on the Nasdaq with an upsized initial public offering which the biotech will use to support its pipeline of anti-CD19 CAR T therapy candidates.
The FDA’s Oncologic Drugs Advisory Committee will meet on March 15 to discuss BMS and J&J applications for their CAR T-cell therapies Abecma and Carvykti, respectively.
PRESS RELEASES