MORRISVILLE, N.C. - Liquidia Corporation (NASDAQ: LQDA), a biopharmaceutical company, has initiated legal proceedings against the U.S. Food and Drug Administration (FDA) over the agency's grant of exclusivity to a competitor's drug, which has delayed the market entry of Liquidia's own treatment for rare cardiopulmonary diseases.
The litigation, filed in the U.S. District Court of the District of Columbia, challenges the FDA's recent decision to award 3-year new clinical investigation exclusivity (NCI exclusivity) to Tyvaso DPI®, a product developed by United Therapeutics (NASDAQ:UTHR). This exclusivity prevents the final approval of Liquidia's YUTREPIA™ (treprostinil) inhalation powder, which received tentative FDA approval on August 16, 2024, for treating pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).
According to Liquidia's CEO, Dr. Roger Jeffs, the FDA's action "improperly allows United Therapeutics to tack on yet another regulatory exclusivity, stifling competition and patient choice." He contends that the FDA's decision goes against the legislative intent of NCI exclusivity, which is meant to reward genuine innovation backed by new clinical studies showing safety and/or efficacy.
In a separate but related development, United Therapeutics has voluntarily dismissed its complaint against the FDA regarding the acceptance of Liquidia's amended New Drug Application (NDA) for YUTREPIA for review. The FDA's tentative approval indicates that it was proper for Liquidia to add PH-ILD to the NDA via an amendment.
YUTREPIA, designed using Liquidia's proprietary PRINT® technology, is an inhaled dry-powder formulation of treprostinil aimed at treating PAH and PH-ILD. The drug is currently under study in the ASCENT trial to evaluate its dosing and tolerability profile in patients with PH-ILD.
Liquidia is focused on the development and commercialization of treatments for rare cardiopulmonary diseases, including a sustained-release formulation of treprostinil and a generic Treprostinil Injection for the treatment of PAH. The company is pursuing final approval of YUTREPIA to meet the needs of PAH and PH-ILD patients as swiftly as possible.
This article is based on a press release statement from Liquidia Corporation.
In other recent news, Liquidia Technologies (NASDAQ:LQDA) saw a series of adjustments in its stock price target by multiple firms, following the FDA's decision to grant a competitor's drug, Tyvaso, regulatory exclusivity until May 2025. H.C. Wainwright maintained a Buy rating but reduced the price target to $29.00, citing the lengthy legal process Liquidia is expected to pursue against the FDA. BofA Securities also maintained a Buy rating but brought the target price down to $23.00, in response to the FDA's updated approval timeline for Liquidia's product, Yutrepia. Jefferies and BTIG followed suit, reducing their price targets to $17.00 and $25.00, respectively, while maintaining Buy ratings.
On the other hand, Goldman Sachs (NYSE:GS) retained a Neutral rating for United Therapeutics, acknowledging the firm's advantage following the FDA's decision. The exclusivity period for Tyvaso, a product of United Therapeutics, delays the market entry of Yutrepia, Liquidia's competing product.
In terms of financial performance, Liquidia reported a decrease in revenue to $3.7 million in Q2 2024, down from $4.8 million in the same quarter of the previous year. However, the company maintains a comfortable cash reserve of $133 million. These are the recent developments for both Liquidia Technologies and United Therapeutics.
InvestingPro Insights
In the midst of Liquidia Corporation's legal battle with the FDA, investors are closely monitoring the company's financial health and market position. According to real-time data from InvestingPro, Liquidia's market capitalization stands at $766.4 million, reflecting the market's current valuation of the company. Despite the challenges, Liquidia's gross profit margin remains strong at 69.52% for the last twelve months as of Q2 2024, indicating a robust ability to convert revenue into gross profit.
However, the company's stock has experienced significant volatility, with a one-week price total return showing a decline of 27.84%. This may be attributed to the concerns over the delayed market entry of Liquidia's YUTREPIA™. InvestingPro Tips highlight that analysts do not anticipate the company will be profitable this year, which is a crucial consideration for investors. Furthermore, the company's net income is expected to drop, and the stock is currently trading at a high Price / Book multiple of 12.22, suggesting a premium valuation relative to the company's book value.
For investors seeking a deeper analysis, InvestingPro offers additional tips on Liquidia Corporation, which can be found at https://www.investing.com/pro/LQDA. These insights could provide a more comprehensive understanding of the company's financial situation and future prospects.
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