Avalyn Pharma Inc. Common Stock

Avalyn Publishes Phase 1 Data Highlighting AP02’s Lung-Targeted Delivery and Encouraging Safety Profile

Avalyn Pharma published Phase 1 results for AP02 (nebulized nintedanib) in the peer-reviewed journal Respiratory Research, with the inhaled antifibrotic generally well tolerated across two randomized studies and no serious adverse events or treatment-related withdrawals. The lung-targeted profile was the headline finding: at a 4.0 mg dose, AP02 achieved roughly 26-fold higher predicted drug exposure in lung lining fluid than 150 mg oral nintedanib, while systemic exposure was 10- to 56-fold lower than the approved oral dose across multiple-ascending-dose cohorts. Avalyn has advanced AP02 into the AURA Phase 2 trial, a 12-week, 160-patient study in idiopathic pulmonary fibrosis; enrollment is on track and topline data are expected in late 2027, making that the next major catalyst for the stock.

•1mo ago

Avalyn Appoints Robert J. Meyer, MD, to its Board of Directors

Avalyn Pharma appointed Robert (Bob) J. Meyer, MD, a board-certified pulmonologist and former senior FDA official, to its board of directors. Meyer spent more than 15 years at the FDA, including as Director of the Office of Drug Evaluation II overseeing pulmonary and allergy drug review, and later held senior regulatory leadership roles at Merck Research Laboratories. CEO Lyn Baranowski said Meyer's guidance will be invaluable as Avalyn advances AP01 (Phase 2b MIST trial in progressive pulmonary fibrosis), AP02 (Phase 2 AURA trial in idiopathic pulmonary fibrosis), and the AP03 combination candidate through clinical development.

•1mo ago

Avalyn Presents New Data at ERS Congress 2026 Supporting AP01 Lung Distribution and Patient-Centered Trial Design in Pulmonary Fibrosis

Avalyn Pharma presented new data at the ERS International Congress 2026 showing that in silico modeling predicts broad AP01 aerosol distribution throughout the lung, including in severely fibrotic lungs. The modeling used the Ebenbuild Twinhale platform with 3D lung models derived from HRCT scans of healthy, mild IPF, and severe IPF lungs, with alveolar and thoracic tissues accounting for the majority of deposited aerosol mass in all models — the primary sites of fibrotic remodeling. A companion survey of IPF patients found strong willingness to participate in clinical research, including long-distance travel and placebo-controlled studies, with clear communication and reduced logistical burden cited as key engagement drivers for future trial design. AP01, an optimized inhaled formulation of pirfenidone, is being evaluated in the global Phase 2b MIST trial in progressive pulmonary fibrosis, while AP02 (inhaled nintedanib) is in the Phase 2 AURA trial in IPF.

•1mo ago

Avalyn Reports Second Quarter 2026 Financial Results and Recent Business Highlights

Avalyn completed enrollment in the MIST Phase 2b trial of AP01, randomizing 398 patients against a target of 375, with topline data expected in the second half of 2027. The company reported a cash position of $413.5 million as of June 30, 2026, which includes net proceeds of approximately $316.6 million from its May 2026 IPO and funds operations into 2029. Q2 2026 net loss was $28.9 million, driven primarily by R&D expenses of $24.7 million associated with the ongoing AP01 and AP02 trials.

•2mo ago

Avalyn Completes Target Enrollment in Phase 2b MIST Trial of AP01 (Inhaled Pirfenidone) for Patients with Progressive Pulmonary Fibrosis

Avalyn Pharma completed target enrollment of 375 patients in its Phase 2b MIST trial of inhaled pirfenidone AP01 for progressive pulmonary fibrosis, reaching this milestone ahead of schedule. The randomized, placebo-controlled trial is evaluating two dose levels with a primary endpoint of change in lung function (FVC) at 52 weeks, and topline data is anticipated in the second half of 2027. Management highlighted strong enthusiasm from investigators and patients as a driver for the enrollment pace, citing a demand for new treatment options that may offer improved tolerability.

•4mo ago

Avalyn Reports First Quarter 2026 Financial Results and Recent Business Highlights

Avalyn Pharma reported Q1 2026 results with a net loss of $26.9 million, driven by $22.9 million in R&D expenses as it advances its inhaled pulmonary fibrosis programs. The company highlighted strong liquidity, with $123.1 million in cash on hand plus $316.1 million in net proceeds from its recent $345 million IPO, providing a runway into 2029. Clinically, the MIST Phase 2b trial for AP01 is on track for mid-2026 enrollment completion, and new open-label extension data presented at EULAR supports a favorable tolerability profile for AP01 in progressive pulmonary fibrosis.

•4mo ago

Avalyn Announces Additional Long-term Data on AP01, Inhaled Pirfenidone, for the Treatment of Pulmonary Fibrosis to be Presented at the European Alliance of Associations for Rheumatology 2026

Avalyn Pharma will present long-term tolerability data for AP01 (inhaled pirfenidone) at the EULAR 2026 conference in London. The poster highlights findings from the ATLAS open-label extension trial, covering up to four years of treatment in patients with progressive pulmonary fibrosis. The data supports the potential for AP01 to preserve lung function while improving tolerability compared to historical oral pirfenidone, de-risking the upcoming Phase 2b MIST trial.

•5mo ago

Avalyn Strengthens Leadership Team to Support Long-Term Growth with Appointments of Industry Leaders Adam Golden and Frank Salisbury

Avalyn Pharma appointed Adam Golden as General Counsel and Head of Business Development and Frank Salisbury as Senior Vice President, Commercial to strengthen its leadership team. Golden brings over 30 years of legal and business development experience, while Salisbury offers 24 years of commercial expertise including the launch of FDA-approved therapies like ESBRIET. These strategic hires are designed to support Avalyn's clinical programs and prepare the company for future commercialization and its transition to life as a public company.

•6mo ago