Liquidia (LQDA) Stock News

The FDA has approved Liquidia's (NASDAQ: LQDA) YUTREPIA™, a novel inhalation powder form of treprostinil for treating adults with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). YUTREPIA is the first prostacyclin dry-powder formulation using Liquidia's proprietary PRINT™ technology, designed for enhanced deep-lung delivery through a low-effort device. The approval is based on the successful Phase 3 INSPIRE trial, which demonstrated safety and tolerability in both treprostinil-naïve patients and those transitioning from nebulized treprostinil. However, United Therapeutics (UTHR) has filed a patent infringement complaint and seeks to block YUTREPIA's commercial launch through a temporary restraining order and preliminary injunction, with the motion currently pending.

Liquidia Corporation (NASDAQ: LQDA) faces new litigation from United Therapeutics (UTHR) over alleged patent infringement. The lawsuit, filed on May 9, 2025, in North Carolina's U.S. District Court, concerns UTHR's '782 patent and seeks to prevent Liquidia from commercializing YUTREPIA™, their inhaled treprostinil treatment for PAH and PH-ILD.

The disputed '782 patent is from the same family as UTHR's previously invalidated '793 patent. Notably, the '793 patent was declared invalid by the Patent Trial and Appeal Board (PTAB), a decision upheld through multiple appeals including the Supreme Court. The litigation does not affect FDA's ability to approve YUTREPIA, which has a PDUFA date of May 24, 2025.

Liquidia Corporation (NASDAQ: LQDA) reported Q1 2025 financial results and provided key updates. The company awaits FDA action on YUTREPIA™ with a PDUFA date of May 24, 2025. Notable developments include: the District Court's dismissal of United Therapeutics' cross-claim challenging the PH-ILD amendment, full enrollment of Cohort A in the ASCENT study for PH-ILD patients, and access to up to $100M in additional financing from HealthCare Royalty. Q1 financials show cash position of $169.8M, revenue of $3.1M, and net loss of $38.4M ($0.45 per share). R&D expenses decreased 31% to $7.0M, while G&A expenses increased 48% to $30.1M, primarily due to preparation for YUTREPIA's potential commercialization.

Liquidia Corporation (NASDAQ: LQDA), a biopharmaceutical company focused on rare cardiopulmonary disease treatments, will participate in the BofA Securities 2025 Health Care Conference. The company's CFO/COO Michael Kaseta and CMO Rajeev Saggar will deliver a business update in a fireside chat on May 13, 2025, at 1:40 PM PT / 4:40 PM ET in Las Vegas. Investors can access the webcast through Liquidia's website, where a recording will remain available for at least 30 days after the event.

The U.S. District Court for the District of Columbia has dismissed United Therapeutics' (UTHR) cross-claim challenging Liquidia's (LQDA) amended New Drug Application for YUTREPIA™. The court ruled that UTHR's claim was unripe and lacked standing. The amended NDA seeks to add the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD) to YUTREPIA's label.

The FDA has already granted tentative approval for YUTREPIA and set a PDUFA goal date of May 24, 2025. Final approval can be granted after the blocking regulatory exclusivity expires on May 23, 2025. While UTHR maintains the right to appeal, Liquidia's CEO expressed confidence in the FDA's decision to accept and tentatively approve the amended NDA.

Liquidia Corporation (NASDAQ: LQDA), a biopharmaceutical company focused on rare cardiopulmonary disease therapies, has scheduled its first quarter 2025 financial results announcement for Thursday, May 8, 2025. The company will host a webcast at 8:30 a.m. Eastern Time to discuss the financial results and provide a corporate update. Investors can access the webcast through Liquidia's website, and a replay will be available for one year.

Liquidia (NASDAQ: LQDA), a biopharmaceutical company focused on rare cardiopulmonary disease therapies, has announced its participation in the 24th Annual Needham Virtual Healthcare Conference. The company will deliver a fireside chat presentation on Wednesday, April 9, 2025, at 8:45 a.m. ET.

Investors and interested parties can access the live webcast through the 'Investors' section of Liquidia's website. A recorded version of the presentation will remain available on the company's website for a minimum of 30 days after the event.

Liquidia (NASDAQ: LQDA), a biopharmaceutical company focused on rare cardiopulmonary disease therapies, has announced its participation in the 24th Annual Needham Virtual Healthcare Conference. The company will deliver a fireside chat presentation on Tuesday, April 8, 2025, at 8:45 a.m. ET.

Investors and interested parties can access the live webcast through the 'Investors' section of Liquidia's website. A recorded version of the presentation will remain available for a minimum of 30 days after the event on the company's website.

Liquidia (NASDAQ: LQDA) announced the FDA's acceptance of its New Drug Application (NDA) resubmission for YUTREPIA™ (treprostinil) inhalation powder. The treatment targets pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).

The FDA classified the resubmission as a complete, Class 1 response to the previous action letter from August 16, 2024, which had granted tentative approval for both indications. The agency has set a Prescription Drug User Fee Act (PDUFA) goal date of May 24, 2025.