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Pulmongene‘s PMG1015 Granted FDA Fast Track Designation for Treatment of  Idiopathic Pulmonary Fibrosis (IPF)

Beijing, China – March 25, 2026.  Pulmongene Ltd., a clinical-stage biotechnology company dedicated to pulmonary, fibrotic, and autoimmune diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to PMG1015 for the treatment of Idiopathic Pulmonary Fibrosis (IPF). The designation supports the ongoing development of PMG1015, which will be […]

Pulmongene‘s PMG1015 Granted FDA Fast Track Designation for Treatment of  Idiopathic Pulmonary Fibrosis (IPF) Read More »

Pulmongene Announces FDA Clearance to initiate 52-Week Phase IIb Global MRCT for PMG 1015, a First-in-Class Therapeutic Antibody for IPF

[Beijing, China] – January 19th, 2026. Pulmongene Ltd., a clinical-stage biotechnology company dedicated to pulmonary, fibrotic, and autoimmune diseases, today announced a significant milestone: the U.S. Food and Drug Administration (FDA) has cleared the IND application to initiate a Phase IIb clinical trial for PMG1015 on Jan 10, 2026. This approval greenlights a 52-week, randomized,

Pulmongene Announces FDA Clearance to initiate 52-Week Phase IIb Global MRCT for PMG 1015, a First-in-Class Therapeutic Antibody for IPF Read More »

Pulmongene announces to present PMG1015 Phase 1b Clinical Trial Results as a Late-Breaking Abstract at European Respiratory Society Congress (ERS) 2025

Beijing, China – September 2, 2025 – Pulmongene Ltd., a leading clinical-stage biotechnology company focused on discovering and developing innovative therapies for respiratory disorders and fibrotic diseases, today announced that its Phase 1b clinical trial data for PMG1015 have been selected for a presentation as a Late-Breaking-Abstract at the European Respiratory Society (ERS) International Congress

Pulmongene announces to present PMG1015 Phase 1b Clinical Trial Results as a Late-Breaking Abstract at European Respiratory Society Congress (ERS) 2025 Read More »

Pulmongene Announces First Patient Dosed in Phase 1b Clinical Trial Evaluating PMG1015 in Idiopathic Pulmonary Fibrosis Patients

On July 5, 2023, Pulmongene Ltd. announced that its investigational drug PMG1015 has completed the first administration in a patient with idiopathic pulmonary fibrosis (IPF) at the China-Japan Friendship Hospital. This study is a multicenter, randomized, double-blind, placebo-controlled Phase Ib clinical trial aimed at evaluating the safety, tolerability, and pharmacokinetics of multiple doses of PMG1015

Pulmongene Announces First Patient Dosed in Phase 1b Clinical Trial Evaluating PMG1015 in Idiopathic Pulmonary Fibrosis Patients Read More »

FDA Grants Orphan Drug Designation to Pulmongene’s PMG1015 for treatment of Idiopathic Pulmonary Fibrosis (IPF)

On February 17th, 2023 , Pulmongene Ltd. announced that the company’s investigational drug PMG1015 has been granted Orphan Drug Designation (ODD) for the indication of Idiopathic Pulmonary Fibrosis (IPF). The FDA’s orphan drug designation supports the development of medicines intended to treat rare diseases that affect fewer than 200,000 people in the United States. Products

FDA Grants Orphan Drug Designation to Pulmongene’s PMG1015 for treatment of Idiopathic Pulmonary Fibrosis (IPF) Read More »

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