Incyte Corp. has described bicyclic amine compounds acting as cyclin-dependent kinase 12 (CDK12) inhibitors reported to be useful for the treatment of cancer.
Despite congressional concerns about accelerated approval, the U.S. FDA’s use of the pathway is not slowing down. If anything, it’s picked up pace since Congress gave the agency stronger authority last year to monitor drugs approved based on a surrogate endpoint and to ensure that confirmatory trials are progressing in a timely way.
By the end of this year, it will become apparent whether Morphosys AG has executed one of the biotechnology industry’s boldest pivots in recent years or has instead blown $1.7 billion of investor cash on a dud. The day of reckoning is coming a little sooner than expected for the Planegg, Germany-based firm, as it has completed recruitment in a phase III trial of pelabresib in first-line myelofibrosis ahead of schedule. Top-line data from the study are now expected before year-end, instead of early 2024.
Macrophages are specialized immune cells that can either stimulate or inhibit inflammation. Studies in mice suggest that phosphoinositide 3-kinase γ (PI3Kγ), a key mediator in macrophage signaling pathways predominantly expressed in myeloid cells, may promote immune suppression both in inflammation and in the tumor microenvironment.
Research at Incyte Corp. has led to the development of pyrazoloquinoline derivatives acting as GTPase KRAS (G12C mutant) inhibitors and reported to be useful for the treatment of cancer, inflammatory and immunological disorders.
Research at Incyte Corp. has led to the development of hetero-tricyclic compounds acting as GTPase KRAS (mutant) inhibitors and thus reported to be useful for the treatment of cancer, inflammatory and immunological disorders.
Biotheryx Inc. has entered into a research collaboration and license agreement with Incyte Corp. to discover and develop targeted protein degraders for novel oncology targets.
Incyte Corp.’s bid for a once-daily vs. twice-daily version of the Janus kinase inhibitor Jakafi (ruxolitinib) was foiled, at least temporarily, by a complete response letter (CRL) from the U.S. FDA.
Incyte Corp.’s retifanlimab-dlwr received its first regulatory nod on March 22, with the U.S. FDA granting accelerated approval for the PD-1 inhibitor to treat adults with a rare form of skin cancer, advanced Merkel cell carcinoma.
