Articles from Avalyn Pharma Inc.

Topline results for AP02 (inhaled nintedanib) confirmed safety and tolerability with limited systemic exposure and substantially improved lung exposure compared to oral nintedanib

CAMBRIDGE, Mass., April 10, 2025 (GLOBE NEWSWIRE) -- Avalyn Pharma Inc., a clinical-stage biopharmaceutical company focused on development of inhaled therapies for the treatment of life-threatening pulmonary diseases, today announced that management will participate in the Citi Biotech Private Access Day.

Topline data from the single- and multiple-ascending dose studies confirmed safety and favorable tolerability profile of AP02 at all dose levels

CAMBRIDGE, Mass., Feb. 25, 2025 (GLOBE NEWSWIRE) -- Avalyn Pharma Inc., a clinical-stage biopharmaceutical company focused on development of inhaled therapies for the treatment of life-threatening pulmonary diseases, today announced that Lyn Baranowski, chief executive officer, and Douglas Carlson, chief financial officer and chief business officer, will participate in the TD Cowen 45th Annual Health Care Conference.

CAMBRIDGE, Mass., Dec. 17, 2024 (GLOBE NEWSWIRE) -- Avalyn Pharma Inc., a clinical-stage biopharmaceutical company focused on development of inhaled therapies for the treatment of life-threatening pulmonary diseases, today announced that Lyn Baranowski, chief executive officer of Avalyn, will present at the 43rd Annual J.P. Morgan Healthcare Conference on Tuesday, January 14, 2025, at 3:00 p.m. PT in San Francisco. Ms. Baranowski, CEO; Douglas Carlson, CFO, CBO; Howard Lazarus, M.D., FCCP, CMO; and Melissa Rhodes, Ph.D., COO, will also participate in 1x1 meetings with investors.

CAMBRIDGE, Mass., Nov. 25, 2024 (GLOBE NEWSWIRE) -- Avalyn Pharma Inc., a clinical-stage biopharmaceutical company focused on development of inhaled therapies for the treatment of life-threatening pulmonary diseases, today announced that management will participate in the following upcoming investor conferences in December.

CAMBRIDGE, Mass., Nov. 14, 2024 (GLOBE NEWSWIRE) -- Avalyn Pharma Inc., a clinical-stage biopharmaceutical company focused on development of inhaled therapies for the treatment of life-threatening pulmonary diseases, today announced the appointment of Heather Turner, J.D., former chief executive officer of Carmot Therapeutics, as Chair of its Board of Directors. With the appointment, Niall O’Donnell, Ph.D., Managing Director, RiverVest Venture Partners and early investor in Avalyn, is stepping down as Chair and from the Board of Directors to transition to a Board Observer role.

CAMBRIDGE, Mass., Nov. 04, 2024 (GLOBE NEWSWIRE) -- Avalyn Pharma Inc., a clinical-stage biopharmaceutical company focused on development of inhaled therapies for the treatment of life-threatening pulmonary diseases, today announced that management will participate in the following upcoming investor conferences in November.

CAMBRIDGE, Mass., Oct. 08, 2024 (GLOBE NEWSWIRE) -- Avalyn Pharma Inc., a clinical-stage biopharmaceutical company focused on development of inhaled therapies for the treatment of life-threatening pulmonary diseases, today announced that Lyn Baranowski, Chief Executive Officer, has been named to the 2024 PharmaVoice 100 list – an annual recognition of the 100 most inspiring people in the life sciences industry.

CAMBRIDGE, Mass., Sept. 30, 2024 (GLOBE NEWSWIRE) -- Avalyn Pharma Inc., a clinical-stage biopharmaceutical company focused on development of inhaled therapies for the treatment of life-threatening pulmonary diseases, today announced multiple upcoming presentations at the 22nd International Colloquium on Lung and Airway Fibrosis (ICLAF). The congress will be held October 12-16, 2024, in Athens, Greece.

Trial Design Showcased for the MIST Study, a Recently Initiated Phase 2b Clinical Trial, Evaluating the Efficacy and Safety of AP01 (inhaled pirfenidone) Compared to Placebo in Patients with Progressive Pulmonary Fibrosis (PPF)

MIST Study designed to evaluate the safety and efficacy of AP01 compared to placebo in patients with progressive pulmonary fibrosis (PPF)

CAMBRIDGE, Mass., Aug. 29, 2024 (GLOBE NEWSWIRE) -- Avalyn Pharma Inc., a clinical-stage biopharmaceutical company focused on development of inhaled therapies for life-threatening pulmonary diseases, today announced that management will participate in the following upcoming investor conferences in September.

CAMBRIDGE, Mass., Aug. 26, 2024 (GLOBE NEWSWIRE) -- Avalyn Pharma Inc., a clinical-stage biopharmaceutical company focused on development of inhaled therapies for the treatment of life-threatening pulmonary diseases, today announced multiple upcoming presentations at the European Respiratory Society (ERS) International Congress 2024. The congress will be held September 7-11, 2024, in Vienna, Austria.

Single and Multiple Ascending Study Designed to Evaluate the Safety, Tolerability, and Pharmacokinetics of AP02 in Healthy Volunteers

CAMBRIDGE, Mass., Aug. 05, 2024 (GLOBE NEWSWIRE) -- Avalyn Pharma Inc., a clinical-stage biopharmaceutical company focused on development of inhaled therapies for life-threatening pulmonary diseases, today announced the appointment of Erin Lavelle, former chief operating officer and chief financial officer of ProfoundBio, as an independent member of its Board of Directors. Ms. Lavelle will also serve as Chair of the Audit Committee.

CAMBRIDGE, Mass., Aug. 01, 2024 (GLOBE NEWSWIRE) -- Avalyn Pharma Inc., a clinical-stage biopharmaceutical company focused on development of inhaled therapies for life-threatening pulmonary diseases, today announced that management will participate in the following upcoming investor conferences in August.

CAMBRIDGE, Mass., May 28, 2024 (GLOBE NEWSWIRE) -- Avalyn Pharma Inc., a clinical-stage biopharmaceutical company focused on development of inhaled therapies for life-threatening pulmonary diseases, today announced that management will participate in the Jefferies Global Healthcare Conference.

AP01 (Inhaled Pirfenidone) Treatment Demonstrated Substantially Improved Efficacy and Tolerability Out to 3.5 Years Compared to Historical Data with Oral Pirfenidone

Presentations to Include Long-term Safety and Efficacy Data from the ATLAS Trial Extension Study of AP01 (Inhaled Pirfenidone) for Pulmonary Fibrosis

Industry veteran Douglas Carlson to steer Avalyn’s finance and business functions as company nears late-stage clinical development for lead programs

CAMBRIDGE, Mass., March 06, 2024 (GLOBE NEWSWIRE) -- Avalyn Pharma Inc., a clinical-stage biopharmaceutical company focused on development of inhalation therapies for life-threatening pulmonary diseases, today announced that Lyn Baranowski, chief executive officer of Avalyn, and members of management will participate in the Leerink Partners Global Biopharma Conference.

CAMBRIDGE, Mass., Feb. 06, 2024 (GLOBE NEWSWIRE) -- Avalyn Pharma Inc., a clinical-stage biopharmaceutical company focused on development of inhalation therapies for life-threatening pulmonary diseases, today announced that Lyn Baranowski, chief executive officer of Avalyn, will participate in three upcoming investor conferences:

SEATTLE, Dec. 06, 2023 (GLOBE NEWSWIRE) -- Avalyn Pharma Inc., a clinical-stage biopharmaceutical company focused on development of targeted inhalation therapies for life-threatening pulmonary diseases, today announced that it will participate in the 2023 RBC Capital Markets Healthcare Private Company Conference, being held virtually December 13-14, 2023.

Preclinical data that supported initiation of the completed Phase 1a AP02 inhaled nintedanib study to be presented for the first time at the PFF Summit

Bolstered clinical operations and medical affairs teams as Avalyn prepares to advance its inhaled candidates for pulmonary fibrosis into later stage clinical trials

SEATTLE, Oct. 05, 2023 (GLOBE NEWSWIRE) -- Avalyn Pharma Inc., a clinical-stage biopharmaceutical company focused on development of targeted inhalation therapies for life-threatening pulmonary diseases, today announced that Lyn Baranowski, chief executive officer of Avalyn, will provide a corporate overview and be available for 1x1 meetings at three upcoming investor conferences:

SEATTLE, Sept. 29, 2023 (GLOBE NEWSWIRE) -- Avalyn Pharma Inc., a clinical-stage biopharmaceutical company focused on development of targeted inhalation therapies for life-threatening pulmonary diseases, today announced that Stephen Pham, Ph.D., senior vice president of product development at Avalyn, will give a keynote address during the Formulation & Delivery U.S. 2023 Conference being held October 2-3, 2023, in San Diego, CA. Dr. Pham will discuss the development of inhaled drug-device combinations for the treatment of pulmonary fibrosis.

Financing led by Perceptive Xontogeny Venture Funds, SR One, and Eventide Asset Management, with participation by new and current healthcare investors

Seattle, Sept. 18, 2023 (GLOBE NEWSWIRE) -- Avalyn Pharma Inc., a clinical-stage biopharmaceutical company focused on development of targeted therapies for life-threatening pulmonary diseases, announced thatCEO Lyn Baranowski will lead a workshop during the annual Hanson & Wade IPF Summit on September 19, 2023. Ms. Baranowski and Timothy Whelan, MD, a pulmonologist and professor of medicine at the Medical University of South Carolina, will facilitate a discussion with attending medical and industry professionals on clinical trial strategies that could be employed to improve the development of therapies for pulmonary fibrosis. Topics will include the selection and optimization of drug delivery methods, the impact of dosing regimens and administration routes on clinical studies, and the impact formulations have on immunogenicity and compliance.

Seattle, Sept. 12, 2023 (GLOBE NEWSWIRE) -- Avalyn Pharma Inc., a clinical-stage biopharmaceutical company focused on development of targeted therapies for life-threatening pulmonary diseases, and collaborators made several presentations at the congress of the European Respiratory Society (ERS), demonstrating that treatment with AP01 (inhaled pirfenidone) preserved forced vital capacity in participants with different forms of pulmonary fibrosis in the ongoing AP01-005 open label extension study, which followed the successful Phase 1b ATLAS study in idiopathic pulmonary fibrosis (IPF) patients. Forced vital capacity (FVC) measures the amount of air a person can forcibly exhale and is used by physicians to monitor progression of pulmonary fibrosis.

Seattle, Sept. 11, 2023 (GLOBE NEWSWIRE) -- Avalyn Pharma Inc., a clinical-stage biopharmaceutical company focused on development of targeted therapies for life-threatening pulmonary diseases, today announced the appointment of Melissa Rhodes, Ph.D., D.A.B.T to the newly created position of chief operating officer (COO). Dr. Rhodes has amassed operational and clinical development expertise through her career working with life sciences companies to develop technologies to improve drug delivery for a variety of indications, including respiratory medicines.

Interstitial Lung Disease Experts Present Forced Vital Capacity Results from ATLAS Study

Seattle, Aug. 07, 2023 (GLOBE NEWSWIRE) -- Avalyn Pharma Inc., a clinical-stage biopharmaceutical company focused on development of targeted therapies for life-threatening pulmonary diseases, today announced that it has appointed Howard M. Lazarus, M.D., FCCP, to the newly created position of chief medical officer. Dr. Lazarus brings valuable clinical and drug-development experience to the Avalyn executive team.

SEATTLE , July 27, 2023 (GLOBE NEWSWIRE) -- Avalyn Pharma Inc., a clinical-stage biopharmaceutical company focused on development of targeted therapies for life-threatening pulmonary diseases, announced that CEO Lyn Baranowski will participate in the 43rd annual Canaccord Genuity Growth Conference, which is being held August 7-10, 2023 in Boston, MA. During her scheduled fireside chat, Ms. Baranowski will provide a corporate and clinical update and her strategy for bringing the company’s pipeline of inhaled pulmonary therapies through clinical development. Details of Ms. Baranowski’s presentation are as follows:

SEATTLE, June 15, 2023 (GLOBE NEWSWIRE) -- Avalyn Pharma Inc., a clinical-stage biopharmaceutical company focused on development of targeted therapies for life-threatening pulmonary diseases, announced that CFO Marc Schneebaum will present at the H.C. Wainwright 2nd Annual Private Company Showcase, which is taking place June 20-22, 2023 on Kiawah Island, SC. Mr. Schneebaum will provide a corporate and clinical update and will discuss Avalyn’s targeted approach to treating severe and rare lung diseases with inhaled therapeutics.

SEATTLE, May 23, 2023 (GLOBE NEWSWIRE) -- Avalyn Pharma Inc., a clinical-stage biopharmaceutical company developing inhaled therapies to treat life-threatening pulmonary diseases, today presented safety and tolerability data from the ongoing AP01-005 open-label extension (OLE) trial of AP01 (inhaled pirfenidone), an experimental inhaled drug candidate in development for the treatment of pulmonary fibrosis. The oral presentation reviewed safety and tolerability findings from AP01-naïve participants in the OLE trial as well as data from participants who continued into the OLE study from the Phase 1b ATLAS study, some of whom have been on therapy for at least 3 years. The long-term efficacy and tolerability profile of the AP01-005 roll-over participants indicates a durable and consistent response to AP01 therapy.

- Avalyn CEO to Present in Company Showcase and Moderate Panel Discussion at ATS RIS -

Seattle, WA, May 10, 2023 (GLOBE NEWSWIRE) -- Avalyn Pharma Inc., a clinical-stage biopharmaceutical company developing inhaled therapies to treat life-threatening pulmonary diseases, today announced that Lyn Baranowski, CEO, is planning to present a corporate update during the BioEquity Europe conference being held May 14-16, 2023. The presentation will be made in-person in Dublin, Ireland.

Seattle, April 11, 2023 (GLOBE NEWSWIRE) -- Avalyn Pharma Inc., a clinical-stage biopharmaceutical company developing inhaled therapies to treat life-threatening pulmonary diseases, today reported top-line results from the company’s ongoing open-label extension (OLE) trial for investigational drug AP01 (inhaled pirfenidone). The study (AP01-005) enrolled a total of 41 individuals with idiopathic pulmonary fibrosis (IPF) who had completed the AP01-002 Phase 1b ATLAS study. In addition, Avalyn enrolled two new cohorts of patients who had diagnoses of either IPF or progressive pulmonary fibrosis (PPF), a poorly served segment of the ILD market with high mortality rates. Top-line results for all cohorts after 48 weeks of open-label treatment are consistent with the tolerability and efficacy findings reported in the ATLAS study, data from which were recently published in the journal, Thorax.

Seattle, March 30, 2023 (GLOBE NEWSWIRE) -- Avalyn Pharma Inc., a clinical-stage biopharmaceutical company focused on development of targeted therapies for life-threatening pulmonary diseases, today reported top-line results from the company’s Phase 1 trial for AP02 (inhaled nintedanib). AP02 was generally well tolerated, with no serious adverse events (SAEs) reported among the participants who were administered AP02.

SEATTLE , March 23, 2023 (GLOBE NEWSWIRE) -- Avalyn Pharma Inc., a clinical-stage biopharmaceutical company focused on the development of targeted therapies for life-threatening pulmonary diseases, today reported that results from the Phase 1b ATLAS study were published online in Thorax, an official journal of the British Thoracic Society. The study assessed safety and efficacy of AP01 (inhaled pirfenidone) in adults with idiopathic pulmonary fibrosis (IPF) through 72 weeks. Efficacy and safety results at weeks 24 and 48 are also reported. 

SEATTLE , Nov. 28, 2022 (GLOBE NEWSWIRE) -- Avalyn Pharma Inc., a clinical-stage biopharmaceutical company focused on development of targeted therapies for life-threatening pulmonary diseases, announced that Lyn Baranowski and Marc Schneebaum, Avalyn Pharma’s chief executive and chief financial officers will participate in the 5th Annual Evercore ISI HealthCONx Conference being held virtually November 29 – December 1, 2022.  

Avalyn Pharma Inc., a clinical-stage biopharmaceutical company focused on development of targeted therapies for life-threatening pulmonary diseases, announced the appointment of Lyn Baranowski as chief executive officer. Ms. Baranowski brings more than two decades of experience leading a vast array of functions in biotech, big pharma and venture capital firms.

Avalyn Pharma Inc., a biopharmaceutical company focused on development of improved therapies for life threatening pulmonary diseases, announced today that Marc Schneebaum has joined the company as Chief Financial Officer.

Avalyn Pharma Inc., a biopharmaceutical company focused on development of improved therapies for life threatening pulmonary diseases, presented at the ISAM conference in Boise, Idaho today, the results of the 24 week data of a Phase I/II clinical study of two dose regimens of AP01 (a formulation of pirfenidone optimized for delivery via inhalation) in patients with idiopathic pulmonary fibrosis (IPF). Ninety-one patients with IPF were randomized to 50 mg once daily (n=46) or 100 mg twice daily (n=45), administered by an investigational eFlow® nebulizer (PARI Pharma GmbH). During the first 24 weeks, the high dose group had, on average, no loss of lung function as measured by forced vital capacity (FVC). The low dose group had a progressive loss of lung function. The differences in FVC between the two groups was statistically significant (p=0.049). AP01 was safe and well tolerated at both doses. Flu-like symptoms and GI adverse events most commonly attributed to oral pirfenidone were seen in less than 10% of patients treated with AP01. Adverse events with a frequency of greater that 10% were rash 18%, upper respiratory tract infection 18%, cough 24%. Most subjects have opted to continue in the 12 month extension. Longer term efficacy and safety data will be presented at an upcoming scientific meeting.