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Avalyn Pharma

Inhaled therapies for rare respiratory diseases

Overview

Avalyn Pharma develops inhaled therapies for rare respiratory diseases. Its lead program, AP01, is an inhaled formulation of pirfenidone in Phase 2b trials designed to treat pulmonary fibrosis and other interstitial lung diseases. The inhaled approach aims to deliver therapy directly to the lungs, potentially improving efficacy and convenience while reducing systemic exposure. The company differentiates itself by focusing on inhaled versions of already approved medications to target lung diseases more precisely, addressing conditions with limited treatment options. Its goal is to advance clinical development and move toward commercialization of these inhaled therapies, ultimately improving patient outcomes and quality of life for people with rare lung diseases.

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About Avalyn Pharma

Simplify's Rating
Why Avalyn Pharma is rated
B-
Rated B on Competitive Edge
Rated B on Growth Potential
Rated C on Differentiation

Industries

BiotechnologyHealthcare

Company Size

51-200

Company Stage

IPO

Headquarters

Boston, MA

Founded

2011

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Simplify's take

What believers are saying

  • Avalyn ended Q3 2026 with $386.6 million, funding operations into 2029.
  • AP03 Phase 1 started in Australia in November 2026, expanding the pipeline quickly.
  • ERS 2026 modeling showed AP01 distributed broadly through severely fibrotic lungs.

What critics are saying

  • AP01 Phase 2b data wait until second half 2027, delaying proof of efficacy.
  • AP03 is first-in-human in 2026, making combination tolerability and PK failures likely.
  • If MIST and AURA disappoint in 2027, Avalyn loses its only credible platform thesis.

What makes Avalyn Pharma unique

  • AP01 and AP02 inhaled antifibrotics target lung delivery instead of systemic exposure.
  • Robert J. Meyer joined the board on September 15, 2026, strengthening FDA strategy.
  • Avalyn combines proprietary nebulizer-device engineering with rare pulmonary fibrosis expertise.

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Funding

Total Funding

$717.5M

Above

Industry Average

Funded Over

5 Rounds

IPO funding comparison data is currently unavailable. We're working to provide this information soon!
IPO Funding Comparison Coming Soon

Benefits

  • Hybrid Work Options

Stock Price

Company News

Associated Press
Nov 12th, 2026
Avalyn starts AP03 combo trial, holds $386.6M cash into 2029 as Q3 net loss hits $29.7M

Avalyn Pharma Inc. (Nasdaq: AVLN) reported a third-quarter 2026 net loss of $29.7 million, up from $23.6 million a year earlier. The Boston-based clinical-stage company develops inhaled therapies for rare respiratory diseases. It ended the quarter with $386.6 million in cash, cash equivalents, and marketable securities, which it expects to fund operations into 2029. Research and development spending rose to $25.5 million from $22.1 million, while general and administrative costs reached $7.6 million, up from $3.2 million. Avalyn started a Phase 1 trial of AP03, an inhaled combination of pirfenidone and nintedanib, in healthy volunteers in Australia. Results are expected in the second half of 2027. Data from its AP01 Phase 2b trial are due in the second half of 2027, and AP02 Phase 2 results in late 2027.

MarketBeat
Sep 30th, 2026
Avalyn Pharma (NASDAQ:AVLN) stock jumps 6.4% - here's what happened.

Avalyn Pharma (NASDAQ:AVLN) stock jumps 6.4% - here's what happened. September 30, 2026 Key points. * Avalyn Pharma shares rose 6.4% to $28.84, giving the company a market capitalization of approximately $1.28 billion, though trading volume was 48% below its average. * Analyst sentiment is mixed: Morgan Stanley raised its price target to $57 with an "overweight" rating, while other firms issued or downgraded the stock to "sell." Overall, analysts maintain a "Moderate Buy" consensus with an average target of $60. * Avalyn reported quarterly EPS of negative $0.98, beating estimates of negative $1.03. The clinical-stage biotech is developing inhaled therapies for serious pulmonary diseases, including its lead idiopathic pulmonary fibrosis program, AP01. * MarketBeat previews the top five stocks to own by October 1st. Avalyn Pharma Inc. (NASDAQ:AVLN - Get Free Report) shares were up 6.4% on Wednesday. The stock traded as high as $28.87 and last traded at $28.84. 160,187 shares changed hands during trading, a decline of 48% from the average daily volume of 310,942 shares. The stock had previously closed at $27.10. Analyst upgrades and downgrades. Several analysts have commented on the company. Morgan Stanley upped their price objective on Avalyn Pharma from $53.00 to $57.00 and gave the company an "overweight" rating in a research note on Thursday, August 13th. Weiss Ratings initiated coverage on Avalyn Pharma in a research note on Thursday, August 13th. They issued a "sell (d+)" rating on the stock. Finally, Wall Street Zen lowered Avalyn Pharma from a "hold" rating to a "sell" rating in a report on Sunday, September 20th. Two investment analysts have rated the stock with a Strong Buy rating, two have issued a Buy rating, one has issued a Hold rating and one has given a Sell rating to the company. According to data from MarketBeat, the company has a consensus rating of "Moderate Buy" and an average target price of $60.00. Avalyn Pharma trading up 6.4%. The stock has a market cap of $1.28 billion and a P/E ratio of -1.26. The company has a 50 day simple moving average of $33.54. The company has a current ratio of 33.12, a quick ratio of 33.12 and a debt-to-equity ratio of 0.04. Avalyn Pharma (NASDAQ:AVLN - Get Free Report) last issued its quarterly earnings results on Wednesday, August 12th. The company reported ($0.98) earnings per share (EPS) for the quarter, topping analysts' consensus estimates of ($1.03) by $0.05. Sell-side analysts predict that Avalyn Pharma Inc. will post -3.81 earnings per share for the current year. Hedge funds weigh in on Avalyn Pharma. Several institutional investors and hedge funds have recently added to or reduced their stakes in the business. Montanova Capital LLC purchased a new position in shares of Avalyn Pharma during the 2nd quarter worth approximately $82,402,000. Braidwell LP acquired a new position in Avalyn Pharma during the second quarter worth $26,382,000. State Street Corp acquired a new position in Avalyn Pharma during the second quarter worth $10,501,000. Finally, Bank of New York Mellon Corp purchased a new position in Avalyn Pharma in the second quarter worth $1,321,000. About Avalyn Pharma. Avalyn Pharma is a clinical-stage biopharmaceutical company focused on developing inhaled therapies for serious and progressive pulmonary diseases. The company is working to deliver established antifibrotic medicines directly to the lungs through proprietary inhalation technologies, with the goal of improving treatment and potentially reducing systemic exposure and related side effects. Discover more Derivatives Avalyn's lead program, AP01, is an inhaled formulation of pirfenidone being developed for patients with idiopathic pulmonary fibrosis, a chronic lung disease characterized by progressive scarring and declining respiratory function. Further reading. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. Before you consider Avalyn Pharma, you'll want to hear this. MarketBeat keeps track of Wall Street's top-rated and best performing research analysts and the stocks they recommend to their clients on a daily basis. MarketBeat has identified the five stocks that top analysts are quietly whispering to their clients to buy now before the broader market catches on... and Avalyn Pharma wasn't on the list. While Avalyn Pharma currently has a Moderate Buy rating among analysts, top-rated analysts believe these five stocks are better buys. The AI boom is creating opportunities across semiconductors, cloud computing, enterprise software, infrastructure, cybersecurity, and automation. Inside this report, you'll find 10 companies positioned to benefit as artificial intelligence moves from hype to real-world deployment and becomes a core growth driver for corporate America. Continue following MarketBeat

Yahoo Finance
Sep 16th, 2026
Avalyn appoints former FDA leader Robert J. Meyer to board of directors

Avalyn Pharma has appointed Robert J. Meyer, MD, to its board of directors. Meyer is a former senior FDA leader and distinguished pulmonary physician who most recently served as Principal of Drug and Biologics Products at Greenleaf Health, now Eliquent Life Sciences. Meyer brings over 25 years of leadership experience across regulatory, academic, and industry roles. At the FDA, he served as Director of the Office of Drug Evaluation II within the Center for Drug Evaluation and Research, overseeing the review of pulmonary and allergy drug products. He later held senior positions at Merck Research Laboratories, including Vice President, Global Regulatory Strategy, Policy and Safety. Avalyn is a clinical-stage biopharmaceutical company developing inhaled therapies for serious, rare respiratory diseases.

GlobeNewswire
Sep 16th, 2026
Avalyn appoints Robert J. Meyer, MD, to its Board of Directors.

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

Avalyn Pharma Inc.
Sep 16th, 2026
Avalyn appoints Robert J. Meyer, MD, to its Board of Directors.

Avalyn appoints Robert J. Meyer, MD, to its Board of Directors. Sep 16, 2026 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]

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