U.S. FDA Grants Tentative Approval of YUTREPIA (treprostinil) Inhalation Powder for Patients with Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD) FDA co

U.S. FDA Grants Tentative Approval of YUTREPIA

(treprostinil) Inhalation Powder for Patients with Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension Associated with Interstitial

Lung Disease (PH-ILD)

N.C., August 19,2024 - Liquidia Corporation (NASDAQ: LQDA), a biopharmaceutical

company developing innovative therapies for patients with rare cardiopulmonary disease, announced today 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). Tentative approval indicates

that YUTREPIA has met all regulatory standards for quality, safety and efficacy required for approval in the United States but must

await the expiration of regulatory exclusivity of a competing product before final approval can be granted.

Dr. Roger Jeffs, Ph.D., Chief Executive Officer of Liquidia, said:

"We are pleased that the FDA agreed that our NDA amendment last July was proper, providing a clear path to full approval of

YUTREPIA in both PAH and PH-ILD. However, we are disappointed and disagree with the FDA's decision to simultaneously grant regulatory

exclusivity to United Therapeutics for Tyvaso DPI that encompasses chronic use of essentially any dry-powder formulation of treprostinil

in the approved indications for a three-year period for its new dosage form approved on May 23, 2022. We plan to take quick action

to challenge the FDA's broad grant of regulatory exclusivity and defend the ability for patients to have access to YUTREPIA with

the least delay possible."

approval of YUTREPIA is based on findings from the Phase 3 INSPIRE trial which evaluated patients who were na ve to treprostinil,

as well as those transitioning to YUTREPIA from nebulized treprostinil. YUTREPIA was shown to be safe and well-tolerated regardless of

a patient's previous exposure to treprostinil. Results from the INSPIRE study were published in the Pulmonary Circulation

Journal in 2022 and the Vascular Pharmacology Journal in 2021. The FDA's approval also confirms that the supporting

information related to the manufacturing, testing and supply chain of YUTREPIA meets regulatory standards for quality and safety in accordance

with Good Manufacturing Practices (GMP).

Liquidia remains committed to addressing the unmet needs of PAH and PH-ILD patients and will seek final approval of YUTREPIA as early

Pulmonary Arterial Hypertension (PAH)

Pulmonary arterial hypertension (PAH) is a rare, chronic, progressive disease caused

by hardening and narrowing of the pulmonary arteries that can lead to right heart failure and eventually death. Currently, an estimated

45,000 patients are diagnosed and treated in the United States. There is currently no cure for PAH, so the goals of existing

treatments are to alleviate symptoms, maintain or improve functional class, delay disease progression, and improve quality of life.

Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD)

Pulmonary hypertension (PH) associated with interstitial

lung disease (ILD) includes a diverse collection of up to 150 different pulmonary diseases, including interstitial pulmonary fibrosis,

chronic hypersensitivity pneumonitis, connective tissue disease related ILD, and chronic pulmonary fibrosis with emphysema (CPFE) among

others. Any level of PH in ILD patients is associated with poor 3-year survival. A current estimate of PH-ILD prevalence in the

United States is greater than 60,000 patients, though population size in many of these underlying ILD diseases is not yet known

due to factors including underdiagnosis and lack of approved treatments until March 2021, when inhaled treprostinil was first

approved for this indication.

YUTREPIA (treprostinil) Inhalation Powder

YUTREPIA is an inhaled dry-powder formulation of treprostinil delivered

through a convenient, low-effort, palm-sized device. YUTREPIA was designed using Liquidia's PRINT technology, which enables

the development of drug particles that are precise and uniform in size, shape and composition, and that are engineered for enhanced deposition

in the lung following oral inhalation. Liquidia has completed INSPIRE, or Investigation of the Safety and Pharmacology of Dry

Powder Inhalation of Treprostinil, an open-label, multi-center phase 3 clinical study of YUTREPIA in patients diagnosed with PAH who are

na ve to inhaled treprostinil or who are transitioning from Tyvaso (nebulized treprostinil). YUTREPIA is currently being studied

in the ASCENT trial, an Open-Label Prospective Multicenter Study to Evaluate Safety and Tolerability of Dry Powder Inhaled Treprostinil

in Pulmonary Hypertension, with the objective of informing YUTREPIA's dosing and tolerability profile in patients with PH-ILD. YUTREPIA

was previously referred to as LIQ861 in investigational studies.

Liquidia Corporation is

a biopharmaceutical company developing innovative therapies for patients with rare cardiopulmonary disease. The company's current

focus spans the development and commercialization of products in pulmonary hypertension and other applications of its proprietary PRINT Technology.

PRINT enabled the creation of Liquidia's lead candidate, YUTREPIA (treprostinil) inhalation powder, an investigational drug

for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).

The company is also developing L606, an investigational sustained-release formulation of treprostinil administered twice-daily with a

next-generation nebulizer, and currently markets generic Treprostinil Injection for the treatment of PAH. To learn more about Liquidia,

please visit www.liquidia.com.

a registered trademark of United Therapeutics Corporation.

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