Avalyn Pharma Inc. Common Stock

Avalyn Pharma Inc. has appointed Robert J. Meyer, MD, a pulmonary physician and former senior U.S. Food and Drug Administration leader, to its Board of Directors. Dr. Meyer most recently served as Principal of Drug and Biologics Products at Greenleaf Health, now Eliquent Life Sciences, and previously spent more than 15 years at the FDA, including as Director of the Office of Drug Evaluation II within the Center for Drug Evaluation and Research and, earlier, as Director of the Division of Pulmonary and Allergy Drug Products. He also held senior leadership roles at Merck Research Laboratories, including Vice President, Global Regulatory Strategy, Policy and Safety, and served as Director of the Virginia Center for Translational and Regulatory Sciences at the University of Virginia School of Medicine. Chief Executive Officer Lyn Baranowski said Dr. Meyer's clinical, scientific and regulatory expertise will be invaluable as Avalyn advances AP01, AP02 and its emerging combination therapy candidate AP03 through their next stages of clinical development. Avalyn's AP01, an optimized inhaled formulation of pirfenidone, is being evaluated in the global Phase 2b MIST trial in progressive pulmonary fibrosis, while AP02, an inhaled formulation of nintedanib, is in the global Phase 2 AURA trial in idiopathic pulmonary fibrosis, and AP03 is an inhaled fixed-dose combination of the two antifibrotics.

Avalyn Pharma Inc. presented new data at the European Respiratory Society International Congress 2026 in Barcelona, showing that its inhaled AP01 therapy achieves broad lung distribution even in severe pulmonary fibrosis, and that patient surveys reveal strong willingness to participate in clinical trials if communication and logistics are addressed. The in silico modeling, using the Ebenbuild Twinhale platform and HRCT-based lung models, predicted consistent deposition across healthy, mild IPF, and severe IPF lungs, with most aerosol reaching alveolar and thoracic tissues—key sites of fibrotic disease. A separate survey of IPF patients found that clear communication about risks and benefits, recognition of prior experience, and reduced logistical burden could enhance trial engagement. Avalyn is developing AP01, an inhaled pirfenidone formulation, currently in a global Phase 2b trial for progressive pulmonary fibrosis, alongside other inhaled candidates for idiopathic pulmonary fibrosis.

Several biotech stocks reached 52-week highs on August 7, 2026, driven by strong quarterly results and clinical progress. Halozyme Therapeutics surged 20% to $103.30 after reporting second-quarter revenue of $481 million, a 48% year-over-year increase, and estimating full-year 2026 revenues of $1.83 billion to $1.91 billion, representing 31% to 37% growth. Fennec Pharmaceuticals rose over 6% to $11.66 following a 71% jump in first-quarter net sales to $15.1 million from its PEDMARK therapy, with second-quarter results due August 11. Avalyn Pharma climbed over 3% to $34.15 after its April IPO raised about $316 million, while advancing inhaled therapies AP01 and AP02 in Phase 2 trials. Amylyx Pharmaceuticals hit $24.60 as it progresses the Phase 3 LUCIDITY trial for Avexitide and completed enrollment in a Phase 1 ALS study. Chemed Corporation reached $552.72 after revising its full-year revenue growth estimate to 8.25% to 9.25%, with a Medicare cap billing limitation of $7,000, and reporting an 8.8% second-quarter revenue increase to $673 million.