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The FDA’s Fast Track process allows for expedited review of drugs that are expected to fill an unmet need.

Efzofitimod is a potential first-in-class selective modulator of neuropilin-2 that is designed to downregulate innate and adaptive immune responses in inflammatory disease states.

The BLA submission is supported by data from the PATHFINDER clinical program.

Vamorolone is a first-in-class dissociative steroidal drug that retains the anti-inflammatory activity of corticosteroids but with a novel mechanism of action.