(Reuters) -The U.S. Food and Drug Administration on Monday granted a tentative approval to Liquidia Corp’s drug for patients with a type of lung disorder, but stopped short of a traditional approval, sending its shares down nearly 22% before the bell.
The company said it has to wait for the expiration of regulatory exclusivity of United Therapeutics’ Tyvaso on May 23, 2025 before final approval can be granted.
The company said it will challenge the FDA’s decision to grant regulatory exclusivity to United’s Tyvaso.
(Reporting by Sneha S K and Sriparna Roy in Bengaluru; Editing by Tasim Zahid and Shinjini Ganguli)
