Liquidia Corporation - LQDA STOCK NEWS

Liquidia (NASDAQ: LQDA) has filed a lawsuit challenging the FDA's decision to grant 3-year new clinical investigation exclusivity (NCI exclusivity) to Tyvaso DPI®. This exclusivity is delaying the final approval of Liquidia's YUTREPIA™ (treprostinil) inhalation powder for treating pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) until after May 23, 2025.

Liquidia argues that the FDA's decision violates congressional intent, which allows NCI exclusivity only for true innovations supported by new clinical studies demonstrating safety and/or efficacy. The company believes this exclusivity should be vacated, allowing YUTREPIA to enter the market immediately. Separately, United Therapeutics has voluntarily dismissed its complaint against the FDA challenging the acceptance of Liquidia's amended NDA for YUTREPIA.

Liquidia (NASDAQ: LQDA) has received tentative approval from the FDA for YUTREPIA™ (treprostinil) inhalation powder to treat adults with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). The approval indicates that YUTREPIA meets all regulatory standards but must await the expiration of a competing product's exclusivity before final approval. The FDA confirmed that Liquidia's amendment to add PH-ILD to the YUTREPIA NDA was proper. Final approval may occur after May 23, 2025, following the expiration of Tyvaso DPI's 3-year regulatory exclusivity. The tentative approval is based on the Phase 3 INSPIRE trial results, which showed YUTREPIA to be safe and well-tolerated in both treprostinil-naïve patients and those transitioning from nebulized treprostinil.

Liquidia (NASDAQ: LQDA) announced the presentation of nine encore thematic posters at the PHA 2024 International PH Conference and Scientific Sessions in Indianapolis, Indiana. The posters, to be presented on August 16-17, 2024, focus on the company's investigational products: YUTREPIA™ (treprostinil inhalation powder) and L606 (liposomal treprostinil inhalation suspension sustained-release formulation). These products are being developed for the potential treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).

The posters cover various aspects of clinical trials, including safety, efficacy, pharmacokinetics, and quality of life assessments for both YUTREPIA™ and L606. Key studies presented include the INSPIRE study for YUTREPIA™ and a Phase 3 study for L606. The presentations also explore innovative approaches such as cardiac effort measurement and high-resolution computed tomography for drug deposition analysis.

Liquidia (NASDAQ: LQDA) reported Q2 2024 financial results and provided a corporate update. Key highlights include:

- Cash and cash equivalents: $133.1 million as of June 30, 2024

- Revenue: $3.7 million, down from $4.8 million in Q2 2023

- Net loss: $27.9 million ($0.37 per share), compared to $23.5 million ($0.36 per share) in Q2 2023

The company progressed litigation, maintaining a clear legal path for FDA approval of YUTREPIA for PAH and PH-ILD treatment. Clinical studies for YUTREPIA and L606 advanced, with new data presented at medical conferences. Liquidia remains ready to launch YUTREPIA pending FDA approval.

Liquidia (NASDAQ: LQDA), a biopharmaceutical company focused on developing innovative therapies for rare cardiopulmonary diseases, has announced that it will release its second quarter 2024 financial results on August 7, 2024. The company will host a live webcast at 8:30 a.m. Eastern Time on the same day to discuss the financial results and provide a corporate update. Investors and interested parties can access the webcast through Liquidia's website. For those unable to attend the live event, a rebroadcast will be available and archived for one year on the company's website.

Liquidia (NASDAQ: LQDA) will present seven posters on their investigational products, YUTREPIA™ (treprostinil) inhalation powder and L606 (liposomal treprostinil) inhalation suspension, at the 7th World Symposia of Pulmonary Hypertension (WSPH) in Barcelona, Spain, from June 29 to July 1, 2024.

The presentations will include two live poster sessions and five encore presentations, focusing on the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).

Key studies include efficacy analyses, HRCT chest scans, and safety and tolerability assessments. A global, pivotal placebo-controlled efficacy trial for L606 in PH-ILD is planned for later this year.

On May 31, the U.S. District Court for the District of Delaware denied United Therapeutics' motion to block the launch of Liquidia's YUTREPIA for treating pulmonary hypertension associated with interstitial lung disease (PH-ILD). This ruling enables the FDA to finalize its decision on YUTREPIA's amended New Drug Application (NDA) for both PAH and PH-ILD. Liquidia's CEO, Dr. Roger Jeffs, expressed satisfaction with the court's decision, which highlights UTHR's inability to show substantial merit in their obviousness challenge and lack of public interest in an injunction. The ongoing lawsuit, initiated by UTHR in September 2023, cites patent infringement claims, with a trial slated for June 2025. Previous legal bodies have ruled that YUTREPIA does not infringe UTHR's patents, including the Patent Trial and Appeal Board and the U.S. Court of Appeals, which found the '793 Patent claims unpatentable. UTHR intends to appeal these decisions to higher courts.

Liquidia (NASDAQ: LQDA) announced that Michael Kaseta, Chief Operating Officer and Chief Financial Officer, will update the company's business at the 2024 Jefferies Global Healthcare Conference. The presentation will take place on June 5, 2024, at 9:00 a.m. ET in New York City. A webcast of the event will be available on Liquidia's website, with an archived version accessible for at least 30 days post-event.

Liquidia (NASDAQ: LQDA) announced its Q1 2024 financial results and provided a corporate update. The company highlighted its ongoing efforts to secure FDA approval for YUTREPIA, aimed at treating pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). Legal barriers for FDA approval were removed, and the company is progressing with the ASCENT study of YUTREPIA.

On the financial front, Liquidia reported a revenue of $3.0 million, a decrease from $4.5 million in Q1 2023. Expenses surged, with R&D rising by 91% to $10.1 million and G&A expenses ballooning by 160% to $20.2 million. Net loss for Q1 2024 was $40.9 million, or $0.54 per share, compared to a $11.7 million loss in Q1 2023. Cash and cash equivalents increased to $157.9 million, thanks to significant capital raised through private placements and financing agreements.