Shares of Liquidia Corporation LQDA lost nearly 31% on Monday after the FDA delayed granting full approval to its Yutrepia (treprostinil) inhalation powder in a pair of lung disorder indications.
The FDA granted tentative approval to Yutrepia for a second indication — in adults with pulmonary hypertension associated with interstitial lung disease (PH-ILD). The drug was initially granted tentative approval for use in adults with pulmonary arterial hypertension (PAH) in 2021.
A tentative approval indicates that while a drug meets all regulatory requirement standards for quality, safety and efficacy set by the agency, it ‘must await the expiration of regulatory exclusivity of a competing product before final approval can be granted.’
In this case, the FDA pointed out that the final approval for the Liquidia product might be granted after a three-year regulatory exclusivity granted to United Therapeutics’ UTHR Tyvaso Dry Powder Inhaler (DPI) expires on May 23, 2025. This news had a positive impact on the UTHR stock, which rose 8.6% on Aug 19. Tyvaso DPI is approved in PAH and PH-ILD indications.
Liquidia claims that it will challenge this three-year regulatory exclusivity granted to United Therapeutics’ Tyvaso DPI to provide patients access to the drug ‘with the least delay possible.’
Year to date, Liquidia’s stock has lost 18.6% compared with the industry’s 1.7% fall.
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Both Liquidia and United Therapeutics have been engaged in long-standing patent litigation over Yutrepia approval. In June, LQDA announced that a U.S. District Court denied a motion for preliminary injunction filed by UTHR alleging Yutrepia infringed a Tyvaso patent. At that time, management had claimed that the ruling cleared the FDA’s path to issue a final decision on Yutrepia in PAH and PH-ILD indications.
The tentative approval granted to Yutrepia is supported by data from the phase III INSPIRE study that evaluated patients who were naïve to treprostinil and those patients who were transitioning from nebulized treprostinil. Data from this study showed that Yutrepia was found to be safe and well-tolerated regardless of a patient’s previous exposure to treprostinil.
Liquidia Technologies, Inc. Price
Liquidia Technologies, Inc. price | Liquidia Technologies, Inc. Quote
Zacks Rank & Key Picks
Liquidia currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the overall healthcare sector include Arcturus Therapeutics ARCT and Fulcrum Therapeutics FULC, each sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Arcturus Therapeutics’ 2024 loss per share have improved from $4.39 to $2.60. Estimates for 2025 have improved from a loss of 45 cents to earnings of 21 cents during the same period. Year to date, shares of Arcturus Therapeutics have lost 32.1%.
Earnings of Arcturus Therapeutics beat estimates in each of the last four quarters. Arcturus delivered a four-quarter average earnings surprise of 56.73%.
In the past 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have improved from $1.24 to 48 cents. Estimates for 2025 have improved from $1.71 to $1.51 during the same period. Year to date, shares of Fulcrum Therapeutics have rallied 38.4%.
Earnings of Fulcrum Therapeutics beat estimates in each of the last four quarters. Fulcrum delivered a four-quarter average earnings surprise of 393.18%.
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United Therapeutics Corporation (UTHR) : Free Stock Analysis Report
Arcturus Therapeutics Holdings Inc. (ARCT) : Free Stock Analysis Report
Liquidia Technologies, Inc. (LQDA) : Free Stock Analysis Report
Fulcrum Therapeutics, Inc. (FULC) : Free Stock Analysis Report
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