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On Monday, BTIG adjusted its outlook on shares of Liquidia Technologies (NASDAQ:LQDA), reducing the price target to $25 from the previous $29 while maintaining a Buy rating on the stock. The revision follows the FDA's unusual delay in granting New Clinical Investigation (NCI) Exclusivities for Tyvaso DPI, which was approved in May 2022.
With a significant portion of the NCI exclusivity period already elapsed, the firm anticipates a delay of approximately nine months for the launch of Liquidia's Yutrepia.
The FDA's tentative approval of Yutrepia for both pulmonary arterial hypertension (PAH) and pulmonary hypertension in interstitial lung disease (PH-ILD) suggests a positive outlook for ongoing legal proceedings involving Liquidia and the FDA, as well as no major manufacturing issues detected in the latest regulatory review.
The company also intends to challenge the FDA's decision on late-cycle exclusivity, arguing that the required NCI exclusivity should be based on an efficacy study or a safety study in a new patient population.
Liquidia's management has confirmed that the company has adequate funds to support operations until the expected launch of Yutrepia in the second quarter of 2025. As of the second quarter of 2024, Liquidia reported having $133.1 million in cash and equivalents. The company's timeline for the ASCENT trial and the initiation of Phase 3 clinical development for L606 remains unchanged, with both milestones anticipated around the end of 2024.
The stock price target adjustment by BTIG reflects the removal of the 2024 launch scenarios from their financial model. Despite the revised price target, BTIG reiterates its Buy rating on Liquidia Technologies, signaling continued confidence in the company's prospects.
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