Absent specific policy details, Trump's speech leaves investors guessing about his real plans for the FDA and the drug approval process. He has not yet named an FDA commissioner.
Kite intends to submit a marketing application for KTE-C19 to the U.S. Food and Drug Administration by the end of March.
Current drugs approved to prevent and reduce the frequency of HAE swelling attacks require injections, so BioCryst's once-daily pill has the potential to be more convenient.
The company intends to submit a marketing application for LJPC-501 to the FDA in the second half of the year, pending the outcome of a meeting with regulators.