Phase II
The FDA is calling the study a phase II trial and says the company must run a rodent genotoxicity study before it can continue.
In the last two years, the sheer volume of scientific research focused on COVID-19 has been astounding—thousands of clinical studies, dozens of vaccines and new compounds, and hundreds of approved drugs tested for efficacy against COVID-19.
Biopharma and life sciences companies from across the globe provide updates on their businesses and pipelines.
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.
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.
Sixty-three percent of patients met the primary endpoint of a 2-point or greater improvement in disease severity without worsening of fibrosis.
PRESS RELEASES