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MORRISVILLE, N.C. - Liquidia Corporation (NASDAQ:LQDA), a biopharmaceutical company with a market capitalization of $1.3 billion, has received confirmation from the U.S. Food and Drug Administration (FDA) that its New Drug Application (NDA) resubmission for YUTREPIA™ (treprostinil) inhalation powder has been accepted. The treatment is aimed at patients with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). InvestingPro data shows the stock has surged over 52% in the past six months, reflecting strong investor confidence in the company’s pipeline.
The FDA’s acceptance of the resubmission marks a complete, Class 1 response to a previous action letter, which had granted tentative approval for YUTREPIA for both PAH and PH-ILD on August 16, 2024. The agency has now set a Prescription Drug User Fee Act (PDUFA) goal date of May 24, 2025, for a final decision on the application.
Dr. Roger Jeffs, Ph.D., CEO of Liquidia, expressed satisfaction with the FDA’s prompt response to the resubmission filed earlier this week. He indicated that the company is looking forward to potential final approval and is continuing preparations for YUTREPIA’s market launch. The company maintains a strong financial position with a healthy current ratio of 4.43, indicating solid ability to meet short-term obligations. According to InvestingPro, analysts have set price targets ranging from $20 to $35, suggesting potential upside from current levels.
Liquidia Corporation focuses on the development and commercialization of therapies for rare cardiopulmonary diseases, utilizing its proprietary PRINT® Technology. This technology has facilitated the creation of YUTREPIA™, their lead candidate for treating PAH and PH-ILD. Additionally, Liquidia is developing L606, a sustained-release formulation of treprostinil, and already markets a generic Treprostinil Injection for PAH.
The forward-looking statements included in the company’s announcement carry risks and uncertainties, and the actual results could differ materially from those projected. Among the uncertainties are the potential outcomes of clinical trials, regulatory submissions, and the final FDA action, which could be delayed beyond the PDUFA date. While the company generated $14 million in revenue over the last twelve months, InvestingPro analysis indicates it is not yet profitable. Get access to 10+ additional exclusive ProTips and comprehensive financial metrics with an InvestingPro subscription.
The company’s announcement also contains cautionary statements regarding its future operations and financial position, as well as its strategic and financial initiatives. It is important to note that the actual results could vary significantly due to various risks and uncertainties inherent in the biopharmaceutical industry.
This news is based on a press release statement from Liquidia Corporation. The company’s future plans and prospects are subject to change, and the statements made should not be considered guarantees of future performance.
In other recent news, Liquidia Technologies reported its financial results for the fourth quarter of 2024, revealing a net loss and revenue shortfall compared to analyst expectations. The company posted a Q4 2024 earnings per share (EPS) of -$0.45, missing the forecast of -$0.3821, with revenue at $2.92 million, below the anticipated $4.54 million. Despite these financial challenges, Liquidia has secured a $100 million financing agreement with HealthCare Royalty to support the development and commercialization of its key product, Yutrepia. The commercial launch of Yutrepia, aimed at treating pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease, is anticipated in May 2025. Analyst firms have shown optimism, with Scotiabank raising Liquidia’s stock target to $34, citing Yutrepia’s strong market potential. H.C. Wainwright maintained a Buy rating with a $29 target, while Raymond James affirmed a Strong Buy rating with a $27 target. These ratings reflect confidence in Liquidia’s legal position and potential market opportunities. Liquidia is actively preparing for Yutrepia’s market entry, with a sales team ready to commence activities upon approval.
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