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Mezzion Pharma passes phase 3 study review for heart drug

Fri, 05 Jun 2026 08:00:39 -0400

Mezzion Pharma Co., Ltd. (KOSDAQ: 140410) announced that an independent review of its FUEL-2 Phase 3 study found no need to increase the planned sample size of 436 patients. The study evaluates udenafil, an investigational therapy for single ventricle heart disease with Fontan circulation.

The review was conducted after 50% of patients completed the study's 26-week treatment period. The independent assessment determined that the study can continue as planned without changes to study design, primary endpoint, statistical analysis plan, or projected timelines.

"We believe the successful completion of this independent review marks an important milestone for the FUEL-2 program," said Dean Park,

Mezzion Pharma passes phase 3 study review for heart drug

Fri, 05 Jun 2026 08:00:39 -0400

"We believe the successful completion of this independent review marks an important milestone for the FUEL-2 program," said Dean Park,

Mezzion Pharma Completes FUEL-2 Phase 3 Regulatory Milestone

Fri, 05 Jun 2026 08:00:00 -0400

After independent review, study continues as planned with enrollment on track for completion in 2026

SEOUL, South Korea and FORT LEE, N.J., June 5, 2026 /PRNewswire/ -- Mezzion Pharma Co., Ltd. (KOSDAQ: 140410) today announced the results of a planned independent, blinded statistical review of its ongoing global confirmatory Phase 3 FUEL-2 study evaluating udenafil, its investigational therapy for single ventricle heart disease with Fontan circulation.

Mezzion Pharma Completes FUEL-2 Phase 3 Regulatory Milestone

Fri, 05 Jun 2026 08:00:00 -0400

After independent review, study continues as planned with enrollment on track for completion in 2026

Mezzion Pharma Completes FUEL-2 Phase 3 Regulatory Milestone

Fri, 05 Jun 2026 08:00:00 -0400

After independent review, study continues as planned with enrollment on track for completion in 2026

Mezzion Pharma Completes FUEL-2 Phase 3 Regulatory Milestone

Fri, 05 Jun 2026 08:00:00 -0400

After independent review, study continues as planned with enrollment on track for completion in 2026

Mezzion Pharma Completes FUEL-2 Phase 3 Regulatory Milestone

Fri, 05 Jun 2026 08:00:00 -0400

After independent review, study continues as planned with enrollment on track for completion in 2026

Mezzion Pharma Completes FUEL-2 Phase 3 Regulatory Milestone

Fri, 05 Jun 2026 08:00:00 -0400

After independent review, study continues as planned with enrollment on track for completion in 2026

Mezzion Pharmaceuticals secures financing for Fontan disease trial

Thu, 14 May 2026 07:00:39 -0400

Mezzion Pharmaceuticals Inc. announced it completed strategic financing from institutional investors to support its ongoing global Phase 3 FUEL-2 clinical trial. The trial evaluates udenafil in adolescents and young adults with Fontan circulation, a form of congenital heart disease.

The company did not disclose the amount of financing or identify the participating investors. Mezzion, based in Fort Lee, N.J., is a subsidiary of Mezzion Pharma Co. Ltd. (KOSDAQ: 140410).

The FUEL-2 trial is being conducted across pediatric congenital heart centers internationally. The study aims to evaluate JURVIGO (udenafil) as a potential treatment for patients with single ventricle congenital heart disease and Fontan

Mezzion Pharmaceuticals secures financing for Fontan disease trial

Thu, 14 May 2026 07:00:39 -0400

The company did not disclose the amount of financing or identify the participating investors. Mezzion, based in Fort Lee, N.J., is a subsidiary of Mezzion Pharma Co. Ltd. (KOSDAQ: 140410).

Mezzion Secures Strategic Financing to Support Advancement of Global Phase 3 FUEL-2 Trial in Fontan Patients

Thu, 14 May 2026 07:00:00 -0400

Institutional financing supports continued execution of late-stage program evaluating JURVIGO® (udenafil) in patients living with Fontan circulation

FORT LEE, N.J., May 14, 2026 /PRNewswire/ -- Mezzion Pharmaceuticals, Inc., a late-stage rare disease biopharmaceutical company focused on therapies for patients with single ventricle congenital heart disease and Fontan circulation, today announced the successful completion of strategic financing from institutional investors.

Mezzion Secures Strategic Financing to Support Advancement of Global Phase 3 FUEL-2 Trial in Fontan Patients

Thu, 14 May 2026 07:00:00 -0400

Institutional financing supports continued execution of late-stage program evaluating JURVIGO® (udenafil) in patients living with Fontan circulation

Mezzion Secures Strategic Financing to Support Advancement of Global Phase 3 FUEL-2 Trial in Fontan Patients

Thu, 14 May 2026 07:00:00 -0400

Institutional financing supports continued execution of late-stage program evaluating JURVIGO® (udenafil) in patients living with Fontan circulation

Mezzion Secures Strategic Financing to Support Advancement of Global Phase 3 FUEL-2 Trial in Fontan Patients

Thu, 14 May 2026 07:00:00 -0400

Institutional financing supports continued execution of late-stage program evaluating JURVIGO® (udenafil) in patients living with Fontan circulation

Mezzion receives FDA feedback on udenafil development for kidney disease

Thu, 07 May 2026 09:26:15 -0400

Mezzion Pharma Co., Ltd. (KOSDAQ: 140410) announced it received written feedback from the U.S. Food and Drug Administration following a pre-IND Type C Guidance meeting regarding development of udenafil for autosomal dominant polycystic kidney disease.

The FDA indicated that Mezzion's nonclinical data package combined with prior clinical and safety experience with udenafil may provide a foundation to support development in clinical studies, according to the company's statement.

Udenafil has been studied in multiple clinical programs in other therapeutic areas with multi-year exposure. Mezzion plans to advance the program toward potential Phase 2 clinical and subsequent Phase 3 development in ADPKD.

"We are encouraged

Mezzion receives FDA feedback on udenafil development for kidney disease

Thu, 07 May 2026 09:26:15 -0400

"We are encouraged

Mezzion receives FDA feedback on udenafil development for kidney disease

Thu, 07 May 2026 09:26:15 -0400

"We are encouraged

Mezzion receives FDA feedback on udenafil development for kidney disease

Thu, 07 May 2026 09:26:15 -0400

"We are encouraged

Mezzion Reports Pre-IND FDA Feedback on the Development of Udenafil in ADPKD

Thu, 07 May 2026 09:25:00 -0400

SEOUL, South Korea, May 7, 2026 /PRNewswire/ -- Mezzion Pharma Co., Ltd. today announced written feedback from the U.S. Food and Drug Administration (FDA) following a pre-IND Type C Guidance meeting interaction for the development of udenafil in autosomal dominant polycystic kidney disease (ADPKD).

Based on its review, the FDA indicated that Mezzion's nonclinical data package together with its prior clinical and safety experience with udenafil may provide a reasonable foundation to support development in clinical studies.