Press Releases September 16, 2026 04:01 PM

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

Avalyn Pharma appoints regulatory and pulmonary expert Dr. Robert J. Meyer to Board of Directors to support advancement of inhaled therapies for respiratory diseases.

By Ajmal Hussain
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Avalyn Pharma Inc., a clinical-stage biopharmaceutical company specializing in inhaled therapies for rare respiratory diseases, announced the appointment of Dr. Robert J. Meyer, an experienced pulmonologist and former FDA leader, to its Board of Directors. Dr. Meyer brings extensive clinical, regulatory, and strategic expertise and will help guide Avalyn as it advances its inhaled antifibrotic programs through clinical development, aiming to transform treatment for pulmonary fibrosis.

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

  • Appointment of Dr. Robert J. Meyer, bringing over 25 years of leadership in pulmonary medicine, FDA regulatory experience, and industry expertise.
  • Avalyn is advancing multiple inhaled therapeutic candidates (AP01, AP02, AP03) targeting pulmonary fibrosis with potential for improved efficacy and reduced side effects.
  • The company leverages proprietary drug-device technology to establish new standards in treatment of serious, rare respiratory diseases, addressing a significant unmet medical need.

BOSTON, Sept. 16, 2026 (GLOBE NEWSWIRE) -- Avalyn Pharma Inc. (Nasdaq: AVLN) (“Avalyn” or the “Company”), a clinical-stage biopharmaceutical company pioneering inhaled therapies to transform the treatment paradigm of serious, rare respiratory diseases, today announced the appointment of Robert (Bob) J. Meyer, MD, a distinguished pulmonary physician and former senior U.S. Food and Drug Administration (“FDA”) leader, to its Board of Directors (the “Board”). Dr. Meyer most recently served as Principal of Drug and Biologics Products at Greenleaf Health, now Eliquent Life Sciences.

"On behalf of the entire Avalyn team, I am thrilled to welcome Bob to our Board of Directors," said Lyn Baranowski, Chief Executive Officer of Avalyn. "As an accomplished pulmonologist and regulatory leader who spent decades shaping the development and review of respiratory therapies at both the FDA and Merck, Bob brings a rare combination of clinical, scientific, and regulatory expertise. His firsthand experience evaluating therapies at the FDA and advancing products through global development programs gives him a unique perspective on the regulatory, clinical, and strategic considerations that drive successful drug development. His guidance will be invaluable as we advance AP01, AP02, and our emerging combination therapy candidate AP03 through their next stages of clinical development and execution."

“Avalyn’s inhaled approach represents a compelling opportunity to address the tolerability challenges that limit the use of current antifibrotic therapies and offer new hope to patients living with pulmonary fibrosis,” said Dr. Meyer. “I am honored to join the Board at this pivotal stage for Avalyn. With multiple programs advancing through development, the Company is well positioned to drive meaningful progress for patients with serious respiratory diseases, and I look forward to supporting its vision of transforming the treatment paradigm for these underserved communities.”

Dr. Meyer brings more than 25 years of leadership experience spanning regulatory, academic, and industry roles. He most recently served as a Principal of Drug and Biologics Products at Greenleaf Health, a leading FDA regulatory consulting firm, advising biopharmaceutical companies on regulatory strategy, clinical development and product approvals. Prior to joining Greenleaf, he served as Director of the Virginia Center for Translational and Regulatory Sciences at the University of Virginia School of Medicine.

Before his academic career, Dr. Meyer spent more than 15 years at the FDA, including serving as Director of the Office of Drug Evaluation II within the Center for Drug Evaluation and Research, where he oversaw the review and regulation of pulmonary and allergy, metabolic and endocrine, analgesic and anesthetic, and rheumatologic drug products. Earlier in his FDA tenure, he served as Director of the Division of Pulmonary and Allergy Drug Products, following roles as a medical reviewer and team leader. He subsequently held senior leadership positions at Merck Research Laboratories, including Vice President, Global Regulatory Strategy, Policy and Safety, where he led worldwide regulatory and pharmacovigilance activities. A board-certified pulmonologist and critical care specialist, Dr. Meyer also brings significant public company and governance experience, having served on the boards of multiple biopharmaceutical companies, including Chimerix, Translate Bio, and Correvio.

About Avalyn Pharma
Avalyn aims to transform the treatment paradigm for pulmonary fibrosis and other serious, rare respiratory diseases. The company is advancing optimized inhaled formulations of established antifibrotic medicines designed to deliver drug directly to the lungs, enhance local efficacy, and reduce systemic side effects. Avalyn’s AP01 program is an optimized inhaled formulation of pirfenidone currently being evaluated in MIST, a global Phase 2b clinical trial in patients with progressive pulmonary fibrosis (PPF). AP01 has indicated encouraging safety and clinical activity across Phase 1b and multi-year open-label extension trials, with long-term data supporting the potential to preserve lung function while improving tolerability relative to historical oral pirfenidone. Avalyn’s AP02 program is an optimized inhaled formulation of nintedanib currently being evaluated in AURA, a global Phase 2 clinical trial in patients with idiopathic pulmonary fibrosis (IPF). Avalyn is also advancing AP03, an inhaled fixed-dose combination of pirfenidone and nintedanib, designed to deliver multiple antifibrotic mechanisms through a single lung-targeted platform. By leveraging its proprietary drug-device approach and deep expertise in rare respiratory disease development, Avalyn aims to establish a new standard of care in pulmonary fibrosis through inhaled, lung-targeted therapies. For more information, please visit avalynpharma.com and follow the company on LinkedIn.        

Investor Contact:
Cassie Saitow, Avalyn Pharma Inc.
Sr. Director, IR and Corporate Communications
[email protected]

Media Contact:
Precision AQ
[email protected]


Risks

  • Clinical development risks: AP01, AP02, and AP03 are in early clinical stages (Phase 2/2b) with inherent uncertainties about efficacy and safety outcomes that could delay or derail approvals.
  • Regulatory risks: Despite Dr. Meyer's expertise, regulatory approval processes remain complex and unpredictable, potentially impacting product launch timelines.
  • Market competition and adoption risks: Emerging therapies face competition in pulmonary fibrosis treatment space; acceptance and commercial success depend on demonstrating significant benefits over existing treatments.

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