You might also like
Liquidia Corporation is a biopharmaceutical company focused on developing, manufacturing, and commercializing products for rare cardiopulmonary diseases. The company leverages its proprietary PRINT® technology to create precise drug particles and improve therapeutic outcomes. Liquidia generates revenue through a partnership with Sandoz Inc. and is advancing its pipeline of innovative treatments for pulmonary arterial hypertension (PAH) and related conditions.
- Treprostinil Injection - Promotes and shares profits from the sale of a generic treprostinil injection used to treat pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) in the United States.
- YUTREPIA (treprostinil inhalation powder) - A lead product candidate designed for the treatment of PAH and PH-ILD, utilizing a dry-powder inhaler for deep lung delivery. Tentatively approved by the FDA but awaiting final approval due to regulatory exclusivity granted to a competing product.
- L606 - An investigational liposomal formulation of treprostinil administered via a nebulizer, currently in clinical development for PAH and PH-ILD.
| Name | Position | External Roles | Short Bio | |
|---|---|---|---|---|
Roger A. Jeffs ExecutiveBoard | Chief Executive Officer | Board Member of Axsome Therapeutics, Inc. | Roger A. Jeffs, Ph.D. is the Chief Executive Officer of Liquidia Corporation since March 19, 2025. He also serves as a member of the Board of Directors at Liquidia Corporation. | View Report → |
Jason Adair Executive | Chief Business Officer | Jason Adair is the Chief Business Officer at Liquidia Corporation since 2023, overseeing corporate development, strategy, investor relations, and communications. He previously served as Senior Vice President, Corporate Development & Strategy in 2022 and as Vice President, Corporate Development & Strategy beginning January 2016. | ||
Michael Kaseta Executive | Chief Operating Officer (COO) | Director of Alimera Sciences, Inc.; Director of Bryn Pharmaceuticals | Michael Kaseta is the COO of Liquidia Corporation since January 15, 2024 and has served as its CFO since November 2020. He has extensive experience in the pharmaceutical and biotech sectors and serves on the boards of external companies. | |
Rajeev Saggar Executive | Chief Medical Officer | Dr. Rajeev Saggar is the Chief Medical Officer at Liquidia Corporation since July 2022. He previously held senior roles including Vice President of Clinical Development at Theravance Biopharma and Interim Chief of the Division of Pulmonary Critical Care at the University of Arizona. | ||
Russell Schundler Executive | General Counsel and Secretary | Russell Schundler has served as General Counsel and Secretary at Liquidia Corporation since March 2021, overseeing all legal matters and regulatory compliance. Previously, he held key legal roles at PBM Capital Group and other organizations, contributing extensive legal expertise in corporate governance. | ||
Scott Moomaw Executive | Chief Commercial Officer | Scott Moomaw is a seasoned leader in the biopharmaceutical industry, serving as the Chief Commercial Officer at Liquidia Corporation since January 2023. Previously, he held the role of Senior Vice President, Commercial starting November 2020 at Liquidia and has contributed to the success of other organizations in key executive positions. |
- With no set timeline for the FDA’s summary judgment decision and a range of potential outcomes discussed, what steps is management taking to accelerate market entry if the decision proves favorable?
- Given the global patient enrollment challenges for L606 and the expected 18- to 24-month trial enrollment period, how will management mitigate risks of recruitment delays across diverse regulatory territories?
- In light of the ongoing litigation over the '327 patent and the potential need to launch YUTREPIA at risk, what contingency plans or criteria would prompt a delay in the product launch?
- Considering prior concerns on payer coverage and early-access friction, what specific strategies are in place to ensure rapid and broad market access upon launch despite competitive pressures from TYVASO DPI?
- With L606's trial design largely modeled after the INCREASE study yet expecting higher doses and different dosing regimens, what benchmarks will determine its success, and how will deviations from expected patient outcomes be managed?
Competitors mentioned in the company's latest 10K filing.
| Company | Description |
|---|---|
The company markets Ventavis, an inhaled prostacyclin analog approved to treat PAH since 2004. Ventavis is administered six to nine times per day via a nebulizer, but its utilization has significantly dwindled due to the more frequent and burdensome treatment regimen. | |
The company markets Tyvaso, a nebulized formulation of treprostinil for PAH and PH-ILD, and Tyvaso DPI, a dry-powder formulation approved in May 2022. It also markets Remodulin, a branded treprostinil injection, and Orenitram, an oral treprostinil product. Additionally, it is developing Ralenipag, a once-daily oral IP agonist, and has been involved in litigation with Liquidia regarding YUTREPIA. | |
The company markets ambrisentan, an endothelin receptor antagonist (ERA) used in the treatment of PAH. Generic versions of ambrisentan are currently available. | |
Bayer Schering Pharma AG | The company markets riociguat, a soluble guanylate cyclase (sGC) stimulator used in the treatment of PAH. |
The company markets sotatercept, an activin signaling inhibitor approved in March 2024 for PAH. Its clinical use is developing, and it may be used prior to prostacyclin therapies, potentially impacting the market potential for YUTREPIA and L606. | |
The company is developing TPIP, a once-daily dry-powder formulation of a treprostinil prodrug for PAH and PH-ILD. It has completed a Phase 2 trial in PAH and a smaller open-label Phase 2 study in PH-ILD. | |
The company is developing seralutinib, a tyrosine kinase inhibitor delivered as an inhaled dry-powder for PAH and PH-ILD. Phase 2 results showed greater effects in patients with severe disease, and Phase 3 studies are planned. | |
Pulmovant | The company is developing mosliciguat, a once-daily inhaled sGC activator for PH-ILD. A Phase 2 study was initiated in 2024 following favorable Phase 1 data. |
The company launched a generic treprostinil for parenteral administration in October 2019, competing with Liquidia's Treprostinil Injection. | |
The company launched a generic treprostinil for parenteral administration in April 2023, adding to the competition for Liquidia's Treprostinil Injection. | |
Alembic | The company received approval in February 2021 for a generic treprostinil for parenteral administration, competing with Liquidia's Treprostinil Injection. |
The company is involved in clinical development programs exploring mechanisms of action that could impact the standard of care for treating PAH and/or PH-ILD. | |
Forsee Pharmaceuticals | The company is exploring mechanisms of action in clinical development that could impact the standard of care for treating PAH and/or PH-ILD. |
Notable M&A activity and strategic investments in the past 3 years.
| Company | Year | Details |
|---|---|---|
RareGen, LLC | 2020 | Liquidia Corporation acquired 100% of RareGen via an all‐stock merger that awarded RareGen members 5,550,000 shares of common stock at closing (with additional shares tied to future sales thresholds), bolstering Liquidia’s PAH capabilities by integrating rights to promote Sandoz’s generic Remodulin® alongside its LIQ861 candidate, and included board realignments with two RareGen directors joining Liquidia’s board. |
Recent press releases and 8-K filings for LQDA.
- Financial Results: Liquidia Corp reported Q1 2025 revenue of $3.1 million, a net loss of $38.4 million, and cash and cash equivalents of $169.8 million .
- Regulatory Update: The company is advancing its YUTREPIA program—with an expected FDA milestone/PDUFA goal date of May 24, 2025—and has shown promising early clinical data from the ASCENT study .
- Legal Clarity: A cross claim by United Therapeutics was dismissed without prejudice, ensuring no active legal actions impede a potential product launch .
- Financing Developments: Liquidia secured strengthened access to up to $100 million under its HealthCare Royalty agreement .
- Revised 2024 Financial Statements: Adjustments to prior statements—eliminating the loss on extinguishment and updating interest expense, long‐term debt, and accumulated deficit—were finalized with an updated audit report from PwC .
- The District Court dismissed, without prejudice, United Therapeutics’ cross-claim challenging Liquidia’s NDA amendment that added the PH-ILD indication for YUTREPIA.
- The ruling supports Liquidia’s regulatory strategy, with the FDA having accepted the amended NDA and final approval anticipated after regulatory exclusivity ends on May 23, 2025; the PDUFA goal date is set for May 24, 2025.
- Liquidia Corporation filed an 8-K report on April 21, 2025, indicating a significant event in its disclosures.
- Its subsidiary, Liquidia Technologies, Inc., initiated a patent infringement lawsuit against United Therapeutics over a patent for dry powder treprostinil used to treat pulmonary hypertension.
- The filing was duly executed by Michael Kaseta, the CFO and COO, underscoring executive oversight of the report.
- YUTREPIA is nearing FDA approval for PAH and PH-ILD with a pivotal PDUFA date set for May 24 following the expiry of TYVASO’s exclusivity.
- The company emphasized the product’s differentiation through its PRINT-enabled technology, which enhances dosing, tolerability, and patient transition from TYVASO.
- Positive early results from the ASCENT trial in PH-ILD were noted, with more detailed data set for presentation at ATS.
- An update was provided on the L606 program, a twice-daily sustained release formulation aimed at improving regimen convenience and consistency.
- The discussion also highlighted a strong capital position, including $176 million in cash and access to additional funding to support the launch and future profitability.
- FDA accepted Liquidia’s NDA resubmission for YUTREPIA treprostinil inhalation powder to treat PAH and PH-ILD with a PDUFA date of May 24, 2025.
- The resubmission is a complete, Class 1 response to a previous FDA action letter, advancing plans for YUTREPIA’s eventual launch.
- Full-year 2024 financials: Revenue reached approximately $14.0 million with a net loss of about $130.4 million, reflecting lower sales volumes and higher operating expenses .
- Amendment to the HealthCare Royalty Agreement: Liquidia secured up to $100 million in additional financing, including $25 million at closing and future tranches linked to approval and sales milestones .
- YUTREPIA’s expanded label: Now tentatively includes both PAH and PH-ILD, with plans to request final FDA approval around May 23, 2025, after competitor exclusivity expires .
- Commercial development support: The additional funds will bolster the continued commercialization of YUTREPIA™ for pulmonary arterial hypertension and other indications .
- Pipeline advancement: Progress continues with efforts towards final FDA approval for YUTREPIA and ongoing clinical studies for the L606 formulation .
- Liquidia Corporation reported in its 8-K filing that on February 27, 2025, a District Court denied the company’s motion for summary judgment in an FDA litigation case, affirming the FDA’s decision to grant a 3‐year regulatory exclusivity for Tyvaso DPI.
- The ruling confirms that the regulatory exclusivity will expire on May 23, 2025, while motions related to pending cross claims by United Therapeutics remain under consideration.