This section highlights FDA-related milestones and regulatory updates for drugs developed by Liquidia (LQDA).
Over the past two years, Liquidia has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
LIQ861 and YUTREPIA. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
LIQ861 (Treprostinil) FDA Regulatory Events
LIQ861 (Treprostinil) is a drug developed by Liquidia for the following indication: Pulmonary arterial hypertension (PAH).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- LIQ861 (Treprostinil)
- Announced Date:
- September 29, 2025
- Indication:
- Pulmonary arterial hypertension (PAH)
Announcement
Liquidia Corporation announced today the company will present two oral presentations at the CHEST 2025 annual meeting on October 19-22, 2025, in Chicago.
AI Summary
Liquidia announced two oral presentations at CHEST 2025, October 19–22 in Chicago, sharing new ASCENT trial findings on LIQ861 in PH-ILD patients through Week 16, covering safety, exploratory efficacy and cardiac effort changes. ASCENT is an open-label, multicenter study evaluating safety and tolerability of dry powder inhaled treprostinil in pulmonary hypertension. Cohort A enrolled 54 patients with WHO Group 3 PH-ILD.
Rapid Fire: Oct 21 at 10:20 a.m.; Dr. Dan Lachant presents “Changes in Cardiac Effort in PH-ILD: Insights from ASCENT,” exploring new diagnostic and monitoring approaches. Late-Breaking Rapid Fire: Oct 21 at 1:52 p.m.; Dr. Nicholas Kolaitis presents “Safety and Exploratory Efficacy Data of LIQ861 DPI Treprostinil in PH-ILD to Week 16,” highlighting advances in pulmonary fibrosis therapy. Slides will be available on Liquidia’s website after the meeting.
Read Announcement- Drug:
- LIQ861 (Treprostinil)
- Announced Date:
- September 11, 2025
- Indication:
- Pulmonary arterial hypertension (PAH)
Announcement
Liquidia Corporation announced today that the company will present four posters at the Pulmonary Hypertension Professional Association (PHPN) Symposium taking place September 18 – 20, 2025, in Seattle.
AI Summary
Liquidia Corporation announced today that it will present four posters at the Pulmonary Hypertension Professional Association Symposium (PHPN), taking place September 18–20, 2025, in Seattle. The symposium attracts clinicians and researchers focused on pulmonary hypertension.
In a live thematic poster session on September 19, Liquidia will share new safety and exploratory efficacy data from its fully enrolled ASCENT study of LIQ861 (YUTREPIA™). This data covers patients with pulmonary hypertension associated with interstitial lung disease through Week 8. Liquidia will also present three previously published posters on YUTREPIA’s effects on cardiac effort, patient quality of life, and device performance under misuse scenarios.
All four posters will be presented on Friday, September 19, from 3:45 to 4:30 p.m. PT. After the event, the posters will be available for download on Liquidia’s Publications page at https://liquidia.com/publications.
Read Announcement
YUTREPIA FDA Regulatory Timeline and Events
YUTREPIA is a drug developed by Liquidia for the following indication: Inhalation Powder.
This drug is approved by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- YUTREPIA
- Announced Date:
- May 23, 2025
- Indication:
- Inhalation Powder
Announcement
Liquidia Corporation announced that the U.S. Food and Drug Administration (FDA) has approved YUTREPIA™ (treprostinil) inhalation powder, a prostacyclin analog for adults with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) to improve exercise ability.
AI Summary
Liquidia Corporation announced that the U.S. Food and Drug Administration (FDA) has approved YUTREPIA™ (treprostinil) inhalation powder for adults with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) to improve exercise ability. This approval is based on data from Liquidia’s Phase 3 INSPIRE study, which demonstrated that YUTREPIA is both safe and well-tolerated. The product is the first prostacyclin analog delivered as a dry powder using Liquidia’s proprietary PRINT™ technology, designed to create uniform, free-flowing particles for enhanced deep-lung delivery. The easy-to-use, low-inspiratory effort device may be especially beneficial for patients with limited lung capacity, offering a promising new treatment option to help improve quality of life and physical performance for those suffering from these serious pulmonary conditions.
Read Announcement- Drug:
- YUTREPIA
- Announced Date:
- May 12, 2025
- Indication:
- Inhalation Powder
Announcement
Liquidia Corporation announced that United Therapeutics Corporation (UTHR) filed a complaint on May 9, 2025, in the U.S. District Court for the Middle District of North Carolina (Case No. 1:25-cv-00368) against Liquidia alleging infringement of U.S. Patent No. 11,357,782 (the ‘782 patent).
AI Summary
Liquidia Corporation announced that United Therapeutics Corporation (UTHR) filed a lawsuit on May 9, 2025, in the U.S. District Court for the Middle District of North Carolina (Case No. 1:25-cv-00368). UTHR alleges that Liquidia infringed U.S. Patent No. 11,357,782 (the “782 patent”) by using a method for administering inhaled treprostinil, a treatment for pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). The complaint also seeks to stop Liquidia from commercializing YUTREPIA™, their investigational treprostinil inhalation powder, if it receives FDA approval. Liquidia’s CEO, Dr. Roger Jeffs, expressed that the litigation is a last-minute strategy by UTHR to limit patient access to alternative therapies. Liquidia maintains that they have invalidated similar claims in the past and will continue to defend patients’ rights to choose the therapy that works best for them.
Read Announcement- Drug:
- YUTREPIA
- Announced Date:
- March 28, 2025
- Indication:
- Inhalation Powder
Announcement
Liquidia Corporation announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) resubmission for YUTREPIA™ (treprostinil) inhalation powder to treat pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).
AI Summary
Liquidia Corporation announced that the FDA has accepted the company’s resubmitted New Drug Application (NDA) for YUTREPIA™ (treprostinil) inhalation powder. This treatment is aimed at patients with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). The FDA has acknowledged the comprehensive resubmission and set a Prescription Drug User Fee Act (PDUFA) goal date of May 24, 2025. Liquidia’s CEO, Dr. Roger Jeffs, expressed satisfaction with the prompt response from the FDA and mentioned that the company is preparing to support a quick launch of YUTREPIA if final approval is granted. The acceptance of the NDA resubmission is a key step forward in Liquidia’s efforts to bring innovative therapies to patients suffering from these serious and rare lung conditions.
Read Announcement- Drug:
- YUTREPIA
- Announced Date:
- March 27, 2025
- Indication:
- Inhalation Powder
Announcement
Liquidia Corporation nnounced the company will present three posters at the American Thoracic Society (ATS) 2025 International Conference, taking place May 18-21, 2025, in San Francisco.
AI Summary
Liquidia Corporation announced it will present three posters at the American Thoracic Society (ATS) 2025 International Conference in San Francisco, scheduled for May 18-21, 2025. The posters focus on data from the ASCENT study of YUTREPIA™, an inhaled dry-powder form of treprostinil designed for patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD). Two posters will highlight key findings on safety, tolerability, improvements in six-minute walk distance, changes in cardiac effort, and quality of life in PH-ILD patients. A third poster presents a case study on a patient with pulmonary arterial hypertension (PAH) who transitioned from parenteral treprostinil to YUTREPIA™, emphasizing long-term safety and tolerability. After the conference, all posters will be available on Liquidia’s Publications page, providing deeper insights into their ongoing research and the potential benefits of this innovative therapy.
Read Announcement- Drug:
- YUTREPIA
- Announced Date:
- March 19, 2025
- Indication:
- Inhalation Powder
Announcement
Liquidia Corporation Provides Corporate Update
AI Summary
Liquidia Corporation provided a corporate update highlighting its progress toward final FDA approval for YUTREPIA™, an inhaled form of treprostinil, once regulatory exclusivity expires on May 23, 2025. The company is optimistic about the approval and commercialization of YUTREPIA for treating pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).
Liquidia also discussed advancements in its clinical pipeline, noting that the open-label ASCENT study is nearly complete and showing encouraging results regarding the drug's tolerability and titratability in PH-ILD patients. Additionally, the company continues to develop L606, a sustained-release formulation of treprostinil administered via a next-generation nebulizer. Financially, Liquidia has strengthened its position through an amendment with HealthCare Royalty Partners, potentially adding up to $100 million in funding, which supports its strategic plans moving forward.
Read Announcement- Drug:
- YUTREPIA
- Announced Date:
- August 22, 2024
- Indication:
- Inhalation Powder
Announcement
Liquidia Corporation announced that it has filed litigation in the U.S. District Court of the District of Columbia (Case No. 1:24-cv-02428) that challenges the recent decision by the United States Food and Drug Administration (FDA) to grant 3-year new clinical investigation exclusivity (NCI exclusivity) to Tyvaso DPI®.
AI Summary
Liquidia Corporation has filed a lawsuit in the U.S. District Court for the District of Columbia (Case No. 1:24-cv-02428) to challenge the FDA's recent decision to award a 3-year new clinical investigation exclusivity (NCI exclusivity) to Tyvaso DPI®. This exclusivity delays the final approval of Liquidia’s YUTREPIA™ (treprostinil) inhalation powder until May 23, 2025. Liquidia argues that extending this period of exclusivity gives United Therapeutics an undue regulatory advantage and violates the intent of Congress, which aims to encourage innovation by rewarding only those drugs supported by new clinical studies. Liquidia contends that the FDA's decision stifles competition and limits patient choice. The company is actively seeking to have this exclusivity vacated so that YUTREPIA can be brought to market promptly for patients with rare cardiopulmonary conditions.
Read Announcement- Drug:
- YUTREPIA
- Announced Date:
- August 19, 2024
- Indication:
- Inhalation Powder
Announcement
Liquidia Corporation announced that that the U.S. Food and Drug Administration (FDA) has granted tentative approval of YUTREPIA™ (treprostinil) inhalation powder to treat adults with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).
AI Summary
Liquidia Corporation announced that the U.S. Food and Drug Administration (FDA) has granted tentative approval for YUTREPIA™ (treprostinil) inhalation powder. The approval allows its use for treating adults with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). This decision confirms that the YUTREPIA application meets all FDA requirements for quality, safety, and efficacy, including adherence to good manufacturing practices at its facilities.
While the drug is approved on a tentative basis, final approval is expected once the three-year regulatory exclusivity for a competing product, Tyvaso DPI, expires on May 23, 2025. Liquidia is moving quickly to address any concerns related to this exclusivity so that patients can gain access to YUTREPIA as soon as possible.
Read Announcement- Drug:
- YUTREPIA
- Announced Date:
- August 16, 2024
- Indication:
- Inhalation Powder
Announcement
Liquidia Corporation announced that the company will present nine encore thematic posters at the PHA 2024 International PH Conference and Scientific Sessions taking place August 15 to August 18, 2024 in Indianapolis, Indiana.
AI Summary
Liquidia Corporation announced that it will present nine encore thematic posters at the PHA 2024 International PH Conference and Scientific Sessions in Indianapolis, Indiana. The event is scheduled from August 15 to August 18, 2024, with Liquidia’s posters set for Friday, August 16 (8:00 a.m. – 5:30 p.m. EDT) and Saturday, August 17 (9:00 a.m. – 1:00 p.m. EDT).
The posters highlight Liquidia’s investigational products, including YUTREPIA™ (treprostinil) inhalation powder and L606 (liposomal treprostinil) inhalation suspension. These projects aim to improve treatment for pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). The sessions will provide insights into safety, efficacy, and new clinical outcomes from ongoing studies, offering an opportunity for professionals to discuss the latest research findings and potential benefits for patients. All poster details are available on Liquidia’s website.
Read Announcement- Drug:
- YUTREPIA
- Announced Date:
- June 3, 2024
- Indication:
- Inhalation Powder
Announcement
Liquidia Corporation v announced today that on May 31, Judge Andrews of the U.S. District Court for the District of Delaware (District Court) denied the motion for preliminary injunction filed by United Therapeutics (UTHR) that sought to block the launch of Liquidia's YUTREPIA™ (treprostinil) inhalation powder to treat pulmonary hypertension associated with interstitial lung disease (PH-ILD).
AI Summary
Liquidia Corporation announced that on May 31, Judge Andrews of the U.S. District Court for the District of Delaware denied United Therapeutics’ motion for a preliminary injunction aimed at blocking the launch of its YUTREPIA™ (treprostinil) inhalation powder. This product is being developed to treat pulmonary hypertension associated with interstitial lung disease (PH-ILD). The judge ruled that United Therapeutics failed to provide sufficient evidence or show that public interest would be served by halting YUTREPIA’s launch. This decision clears a key hurdle, reinforcing that there is no legal impediment for the FDA to issue a final decision on the amended New Drug Application for YUTREPIA. Liquidia expressed confidence as it continues commercial preparations for the treatment, which also targets pulmonary arterial hypertension (PAH). The ruling allows the company to proceed with its marketing and regulatory plans while the ongoing lawsuit moves forward toward trial in the future.
Read Announcement
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