FDA DelayDisappointed with a -2% performance mostly due to the mid-Aug setback when FDA delayed approval by retroactively granting Tyvaso DPI a 3-yr exclusivity dating to 2022.
Patent LitigationOn the 3Q call, LQDA would not firmly commit to immediately launching Yutrepia in May for the ILD indication, which would be at-risk to ongoing ‘327 patent litigation.
Regulatory ChallengesLQDA is challenging FDA's decision to delay final approval until after expiration of Tyvaso DPI exclusivity.