Lycera Corp. develops small-molecule immunomodulators. Its lead benzodiazapene-based compounds have shown efficacy in animal models of lupus, psoriasis, rheumatoid arthritis, inflammatory bowel disease and transplant rejection. Lycera also recently acquired a program targeting the TH17 pathway, which controls production of IL-17, a pro-inflammatory cytokine increasingly considered critical to inflammation and autoimmune disease.
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CEO Paul Stoffels said gaining US clearance for an IND for its novel CAR-T product was demanding, but now opens up a pathway towards a pivotal study starting in 2025.
A final rejection of Leqembi could also spell the same fate for Lilly’s rival drug but public outcry and demand for Alzheimer’s therapies might force the regulator’s hand
Reimbursement rules are disincentivizing innovation, according to Vas Narasimhan.
Recent moves in the industry include changes at the top at Ascentage Pharma, Inventiva and Brenig Therapeutics, plus five companies get new CFOs.
As AI-driven firms like Insilico, big pharma like J&J, Amgen, GSK and AstraZeneca and Chinese and Indian firms like BeOne and Dr. Reddy’s respectively advance PRMT5 inhibitor candidates, what’s driving interest, what could lead to the first global approval and what are the challenges ahead?
