Vertex Pharmaceuticals (VRTX) announced that the European Commission (EC) has expanded the label of its blockbuster cystic fibrosis (CF) drug, Kaftrio, to treat all patients aged two years and older who have at least one non-class I mutation in the CFTR gene.This approval was expected as the EMA’s Committee for Medicinal Products for Human Use (“CHMP”) issued a positive opinion recommending Kaftrio’s approval in February for the above indication. With this expanded label, nearly 4,000 more CF patients livin ...

Core Viewpoint - Gyre Therapeutics has received approval from the National Medical Products Administration (NMPA) in China for a clinical trial application to evaluate pirfenidone for treating radiation-induced lung injury (RILI) and immune-related pneumonitis (CIP) in cancer patients [1][2]. Company Overview - Gyre Therapeutics is a biotechnology company focused on organ fibrosis, with a commercial-stage product, pirfenidone, which is currently approved for idiopathic pulmonary fibrosis (IPF) [1][7]. - The company is headquartered in San Diego, CA, and is advancing a broad pipeline in China through its indirect controlling interest in Gyre Pharmaceuticals [8]. Clinical Trial Details - The approved trial will utilize an adaptive Phase 2/3 design to explore dosing and confirm efficacy for pirfenidone in the new indication [2]. - Gyre plans to initiate the trial in the second half of 2025 at leading academic and oncology centers across China [6]. Medical Context - RILI affects 5%–25% of lung cancer patients undergoing radiation therapy, which can limit treatment efficacy [3]. - CIP occurs in 13%–19% of patients treated with immune checkpoint inhibitors, contributing to a significant percentage of immune-related adverse event deaths [4]. - Currently, there are no targeted therapies for lung injuries caused by radiation or immunotherapy, with corticosteroids being the standard treatment despite their long-term side effects [5]. Drug Mechanism - Pirfenidone is an orally administered small molecule that inhibits TGF-β signaling and fibroblast proliferation, showing clinical benefits in slowing lung function decline in IPF [7].

Pliant Therapeutics (PLRX) FY Conference January 10, 2023 10:30 AM ET Speaker0 All right. Good morning. Welcome back to the JPMorgan Healthcare Conference. I'm Eric Joseph, Senior Biotech Analyst with the firm. Our first presenting company this morning is Playant Therapeutics, and it's my pleasure to welcome and introduce CEO, Bernard Cooley, to talk to us a bit about the company. There'll be a Q and A after the presentation. There'll be mic circulating around the room. And for those joining online, feel fr ...