Liquidia’s Yutrepia Receives Tentative FDA Approval Due to Tyvaso Exclusivity

Tentative Approval:
Liquidia's Yutrepia (treprostinil inhalation powder) received tentative approval from the FDA for treating pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).

Exclusivity Issue:
The FDA granted tentative approval due to United Therapeutics' Tyvaso DPI having a three-year regulatory exclusivity period, which expires on May 23, 2025.

Clinical Trials:
The approval was based on data from the Phase III INSPIRE trial, which showed Yutrepia to be safe and well-tolerated in both treprostinil-naïve patients and those transitioning from other inhaled treprostinil treatments.

Market Impact:
Liquidia's shares dropped significantly (around 30-40%) following the announcement due to the delay in full approval.

Legal Action:
Liquidia plans to challenge the FDA's broad grant of regulatory exclusivity to United Therapeutics to expedite patient access to Yutrepia.