Liquidia Corporation Stock Price, News & Analysis

Liquidia (NASDAQ: LQDA), a biopharmaceutical company focused on rare cardiopulmonary disease therapies, has scheduled its third quarter 2024 financial results announcement for November 11, 2024. The company will host a live webcast at 8:30 a.m. Eastern Time to discuss financial performance and provide a corporate update. The webcast will be accessible through Liquidia's website and will remain archived for one year.

The U.S. Supreme Court has rejected United Therapeutics' petition to appeal previous rulings that invalidated all claims of U.S. Patent No. 10,716,793 ('793 Patent). This decision finalizes the Patent Trial and Appeal Board's July 2022 ruling, affirmed by the Federal Circuit in December 2023, making the '793 patent unenforceable. Liquidia (NASDAQ: LQDA) received tentative FDA approval for YUTREPIA on August 16, 2024, to treat PAH and PH-ILD in adults. Final approval may occur after May 23, 2025, when Tyvaso DPI's regulatory exclusivity expires. No patents currently prevent YUTREPIA's final FDA approval. A separate lawsuit regarding U.S. Patent No. 11,826,327 is scheduled for trial in June 2025.

Liquidia (NASDAQ: LQDA) and Pharmosa Biopharm have expanded their collaboration for the development and commercialization of L606, an inhaled, sustained-release formulation of treprostinil for pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). The amended agreement extends Liquidia's licensed territory beyond North America to include key markets in Europe, Japan, and elsewhere.

Liquidia will pay Pharmosa a $3.5 million upfront payment and up to $157.75 million in additional milestone payments. The collaboration includes rights to Pharmosa's next-generation smart-technology nebulizers. Clinical data for L606 has shown encouraging results, with favorable tolerability and a pharmacokinetic profile supporting twice-daily administration.

Liquidia (NASDAQ: LQDA) announced its participation in the CHEST 2024 annual meeting hosted by the American College of Chest Physicians on October 6-9, 2024, in Boston. The company will present a poster and host a medical theater at the event. The poster, titled "Baseline Characteristics of Patients Enrolled in the ASCENT Study: Evaluating Safety and Tolerability of YUTREPIA™, A Dry Powder Inhaled Treprostinil in Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD)," will be presented on October 9th. It will focus on Liquidia's ongoing clinical trial, dosing and tolerability profiles, and exploratory efficacy endpoints for YUTREPIA in PH-ILD patients.

The medical theater, scheduled for October 7th, will discuss current epidemiologic data on PH-ILD, the clinical data gap regarding dry-powder treprostinil use in PH-ILD, and how Liquidia's ASCENT study is addressing this gap, as well as the future of PH-ILD treatments.

Liquidia (NASDAQ: LQDA) announced that the U.S. District Court for New Jersey has found United Therapeutics' interference with the launch of generic Treprostinil Injection caused losses exceeding $137 million. This decision stems from a 2019 lawsuit filed by Liquidia PAH and Sandoz against United Therapeutics, alleging violations of antitrust laws and unfair competition. The court granted partial summary judgments in March 2022 and has now determined damages from the breach of contract by United Therapeutics.

The final damage award is yet to be determined and will be offset by costs avoided by Sandoz. Proceeds from the litigation will be split equally between Sandoz and Liquidia PAH, with Liquidia PAH's share further divided between Henderson SPV, and PBM RG Holdings, due to litigation finance agreements.

Liquidia (NASDAQ: LQDA) has announced significant financial developments, including:

1. A $67.5 million raise through an underwritten public offering and a concurrent private placement, offering shares at $8.90 per share.

2. An additional $32.5 million funding from HealthCare Royalty (HCRx) through an amendment to their Revenue Interest Financing Agreement (RIFA).

These actions will provide Liquidia with approximately $100 million in gross proceeds. The funds will support the ongoing commercial development of YUTREPIA™ for pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD), as well as other clinical trials and the development of L606.

Liquidia (NASDAQ: LQDA), a biopharmaceutical company focused on rare cardiopulmonary diseases, has announced its participation in two upcoming investor conferences in September 2024. The company will present at the 2024 Wells Fargo Healthcare Conference in Boston on September 5, from 11:00 to 11:35 a.m. ET, and at the 2024 Cantor Global Healthcare Conference in New York on September 19, from 1:30 to 1:50 p.m. ET.

Investors and interested parties can access the webcasts of these presentations through Liquidia's website. Recorded versions of the presentations will be available on the company's website for at least 30 days following each event, providing an opportunity for those unable to attend live to review the information presented.

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.