On Tuesday, H.C. Wainwright maintained a Buy rating on shares of Liquidia Technologies (NASDAQ: NASDAQ:LQDA) but reduced the price target to $29.00 from the previous $32.00. The adjustment follows a discussion with a patent attorney regarding the patent exclusivity recently granted to a competitor's drug, Tyvaso, by United Therapeutics (NASDAQ:UTHR).
The patent attorney clarified the different types of exclusivity under the Hatch-Waxman Act, noting that the New Chemical Entity (NCE) exclusivity for Treprostinil expired five years after the approval of Remodulin.
United Therapeutics, having conducted new clinical trials that provided a basis for approval, was granted three years of Clinical Investigation Exclusivity (CIE) for Tyvaso, which is set to expire on May 23, 2025.
The analyst noted that while Liquidia is expected to pursue litigation against the FDA to challenge United Therapeutics' entitlement to CIE, the legal process is anticipated to be lengthy. The preparation and filing of a complaint, followed by a 21-day period for United Therapeutics to respond, and subsequent court motions could extend the case into the first quarter of 2025.
If the case proceeds without dismissal, the expectation is that a final approval for Liquidia's product, Yutrepia, could occur in the first half of 2025. This timeline suggests a delay of a few quarters from the initial projection of a year-end 2024 launch.
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