Celcuity waits on FDA review of second plant as cancer drug rollout lags expectations

Celcuity has announced that it is awaiting the U.S. Food and Drug Administration’s review of a second manufacturing facility needed for its newly approved cancer therapy.

The company explained that the additional site is required to scale production, and the delay in receiving clearance has slowed the commercial launch compared with early investor expectations.

Celcuity’s statement highlights that the drug itself has already received approval, but the pace of market entry will depend on the FDA’s decision on the new factory.