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Avalyn Pharma Inc. reports news about its clinical-stage development of inhaled therapies for serious, rare respiratory diseases. Recurring company updates cover AP01 and AP02, pulmonary fibrosis research, clinical presentations, peer-reviewed publications, patient-centered treatment research, and respiratory-disease conference activity.
Company news also includes public-company developments such as the closing of its initial public offering, Nasdaq listing of AVLN common stock, capital-structure updates, governance changes, leadership appointments, clinical or regulatory disclosures, and operating and financial results tied to its rare lung disease pipeline.
Avalyn Pharma (Nasdaq: AVLN) reported second quarter 2026 results and pipeline progress, highlighting completion of global enrollment in MIST, its Phase 2b trial of inhaled pirfenidone AP01 in progressive pulmonary fibrosis. The 52-week study overenrolled to 398 patients versus a 375 target, with topline data expected in the second half of 2027.
The AP02 AURA Phase 2 trial in idiopathic pulmonary fibrosis, targeting 160 patients over 12 weeks, has enrollment on track, with topline data anticipated in late 2027. A Phase 1 study of AP03, an inhaled fixed-dose combination of pirfenidone and nintedanib, is planned to start by year-end 2026.
As of June 30, 2026, Avalyn held $413.5 million in cash, cash equivalents and marketable securities, including approximately $316.6 million of IPO net proceeds, which is projected to fund operations into 2029. Second quarter 2026 R&D expenses were $24.7 million and G&A expenses were $6.6 million, leading to a net loss of $28.9 million.
Avalyn (Nasdaq: AVLN) completed target enrollment of 375 patients in its global Phase 2b MIST trial of AP01 (inhaled pirfenidone) for progressive pulmonary fibrosis (PPF). The randomized, double-blind, placebo-controlled study will assess lung function over 52 weeks, with topline 12‑month results expected in the second half of 2027.
Avalyn (Nasdaq: AVLN) reported Q1 2026 results and pipeline progress. Cash, cash equivalents, and marketable securities were $123.1 million on March 31, 2026, excluding IPO proceeds. An upsized IPO raised $345.0 million, with total liquidity projected to fund operations into 2029.
MIST Phase 2b AP01 enrollment is on track to complete mid‑2026, AURA Phase 2 AP02 enrollment is underway with topline data expected in 2027, and AP03 Phase 1 is planned by end‑2026.
Avalyn (Nasdaq: AVLN) will present a company overview at the Jefferies Global Healthcare Conference in New York on June 4, 2026, from 9:55–10:25 a.m. ET. A live webcast and archived recording will be available on Avalyn’s investor relations website.
Avalyn (Nasdaq: AVLN) announced an upcoming EULAR 2026 poster on AP01, inhaled pirfenidone, for progressive pulmonary fibrosis. Updated ATLAS open-label extension data will describe the long-term tolerability profile of AP01 at up to four years of treatment.
The poster, POS1150, will be presented June 6, 2026, in London and made available on Avalyn’s website.
Avalyn (Nasdaq: AVLN) will present two patient-centered research posters at the American Thoracic Society 2026 International Conference in Orlando, May 15-20, 2026.
Presentations cover a usability study of the eFlow® Nebulizer for AP01 (inhaled pirfenidone) and patient perspectives on supportive care in idiopathic pulmonary fibrosis. Posters P60 and P68 will be shown May 18, 11:30 a.m.-1:15 p.m.; abstracts appear in AJRCCM.
Two River and Vida Ventures acknowledged UCB's acquisition of Candid Therapeutics for up to $2.2 billion, including $2.0 billion upfront. Two River and Third Rock helped found Candid via the merger of TRC 2004 and Vignette Bio; Vida was an early investor. The announcement highlights Bellco Health's company-creation and investment track record, and notes Vida's 2025 M&A activity and two oversubscribed 2026 IPOs including Aktis Oncology (AKTS) and Avalyn Pharma (AVLN).
Avalyn (Nasdaq: AVLN) closed its initial public offering on May 1, 2026, selling an aggregate 19,166,667 shares of common stock, which includes the underwriters' full exercise of a 2,500,000-share overallotment option at $18.00 per share.
The aggregate gross proceeds were $345 million before underwriting discounts, commissions and offering expenses. Avalyn's common stock is listed on the Nasdaq Global Select Market under the ticker AVLN. Joint book-running managers were Morgan Stanley, Jefferies, Evercore ISI and Guggenheim Securities.
Avalyn (Nasdaq: AVLN) priced an upsized initial public offering of 16,666,667 common shares at $18.00 per share, expected to raise approximately $300 million in gross proceeds before underwriting discounts, commissions and expenses. The underwriters have a 30-day option to purchase an additional 2,500,000 shares.
Shares are expected to begin trading on the Nasdaq Global Select Market on April 30, 2026, with the offering expected to close on May 1, 2026, subject to customary conditions.
Avalyn (NYSE:AVLN) announced April 27, 2026 the appointments of Adam Golden as General Counsel and Head of Business Development and Frank Salisbury as Senior Vice President, Commercial.
Adam Golden brings over 30 years of legal and business development experience including senior roles at Freshfields, Hogan Lovells, and Kaye Scholer. Frank Salisbury brings 24+ years of commercial leadership and prior launches of therapies including ESBRIET and WINREVAIR. The hires target clinical advancement and commercial readiness ahead of future commercialization.