Clinical research
Cortexyme said it plans to provide additional updates pending further talks with the FDA.
Incyte’s decision follows consultation with the FDA, where it decided that it could not support any confirmatory studies that might be required in the future given the limited time frame.
Vaccinex announced positive interim response data in a Phase Ib study assessing pepinemab in combination with Merck’s vaunted checkpoint inhibitor, Keytruda.
The FDA approved Kimmtrak for the treatment of HLA-A*02:01-positive adults with unresectable or metastatic uveal melanoma (mUM).
The FDA placed a partial clinical hold on studies conducted by Gilead Sciences assessing the combination of magrolimab plus azacitidine due to concerns of unexpected adverse events.
The amount will be used to enhance research and development efforts for KYV-101 that has a strong potential to treat different types of autoimmune illnesses.
In addition to the induction of both mucosal and systemic immunity, advantages of an intranasal approach include the lack of needles, low cost and thermostability under normal refrigeration temperature.
Shares of Mustang Bio have fallen more than 13% in premarket trading after announcing the FDA had placed a hold on the company’s Investigational New Drug application for its bubble boy gene therapy.
The Phase III MOMENTUM trial showed that momelotinib was able to meet its primary endpoint by week 24, specifically a TSS reduction of over 50% compared to the baseline figures.
As Omicron continues to dominate globally, research is coming in every day on this highly contagious variant of SARS-CoV-2.
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