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
YUTREPIA and LIQ861. 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.
YUTREPIA FDA Regulatory Timeline and Events
YUTREPIA is a drug developed by Liquidia for the following indication: Inhalation Powder.
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:
- YUTREPIA
- Announced Date:
- September 3, 2026
- Indication:
- Inhalation Powder
Announcement
Liquidia Corporation announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to YUTREPIA® (treprostinil) inhalation powder for the treatment of Raynaud's phenomenon associated with systemic sclerosis (SSc-RP).
Read Announcement- Drug:
- YUTREPIA
- Announced Date:
- June 11, 2026
- Indication:
- Inhalation Powder
Announcement
Liquidia Corporation announced today that the company will present four posters at the PHA 2026 International PH Conference and Scientific Sessions taking place June 11-14 in Dallas.
AI Summary
Liquidia Corporation said it will present four posters at the PHA 2026 International PH Conference and Scientific Sessions, held June 11-14 in Dallas. The research focuses on pulmonary hypertension and highlights the experiences of patients, caregivers, and care teams. One poster looks at cough outcomes reported by patients during treatment with YUTREPIA in the ASCENT trial. Another examines the mental health strain on caregivers. A third explores how pharmacists support pulmonary hypertension care. The fourth is an encore presentation with safety and early effectiveness data from the ASCENT study through Week 24 in patients with PH-ILD.
Chief Medical Officer Dr. Rajeev Saggar said the company is proud to share research that keeps patients and caregivers at the center of care. He said the work reflects Liquidia’s commitment to people living with pulmonary hypertension every day.
Read Announcement- 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
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
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