FDA delays YUTREPIA PDUFA date; PH-ILD amendment process ongoing

Liquidia Corp

FDA unable to issue action letter by Jan. 24, 2024 PDUFA date; no new goal date set.
No additional clinical data requested; FDA confirming process to add PH-ILD indication.
Federal Circuit upheld PTAB invalidity of '793 patent; '327 patent not subject to 30-month stay.
Company expects final approval after Tyvaso regulatory exclusivity expires March 31, 2024.
YUTREPIA already has tentative approval for PAH; quality, safety, efficacy standards met.

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