Avalyn Pharma (AVLN) FDA Approvals $30.57 +2.50 (+8.91%) As of 02:39 PM Eastern Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsHeadlinesInsider TradesSEC FilingsShort InterestTrendsBuy This Stock Avalyn Pharma's Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by Avalyn Pharma (AVLN). Over the past two years, Avalyn Pharma has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as AP01. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. AP01 FDA Regulatory Events AP01 is a drug developed by Avalyn Pharma for the following indication: Patients with Progressive Pulmonary Fibrosis. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy. Enrollment Update - June 17,2026Enrollment Update Drug: AP01Announced Date: June 17, 2026Indication: Patients with Progressive Pulmonary FibrosisAnnouncementAvalyn Pharma Inc announced that it has completed target enrollment of 375 patients in the Phase 2b MIST clinical trial of AP01 (inhaled pirfenidone) in patients with progressive pulmonary fibrosis (PPF). Additional patients currently in screening remain eligible for randomization and may be enrolled in the trial over the next several weeks.AI SummaryAvalyn Pharma Inc. said it has reached the planned enrollment target of 375 patients in its Phase 2b MIST clinical trial of AP01, an inhaled form of pirfenidone, for people with progressive pulmonary fibrosis (PPF). The study is testing two doses of AP01 against placebo in a global, randomized, double-blind design. MIST assigns patients in a 2:1:2 ratio to AP01 100 mg twice daily, AP01 50 mg twice daily, or placebo. The main goal is to see whether AP01 can improve or slow decline in lung function, measured by forced vital capacity, after 52 weeks. Avalyn said patients still in screening may continue to be enrolled over the next several weeks if they remain eligible.Read Announcement Avalyn Pharma FDA Events - Frequently Asked Questions Has Avalyn Pharma received FDA approval? As of now, Avalyn Pharma (AVLN) has not received any FDA approvals for its therapy in the last two years. What drugs has Avalyn Pharma submitted to the FDA? In the past two years, Avalyn Pharma (AVLN) has reported FDA regulatory activity for AP01. What is the most recent FDA event for Avalyn Pharma? The most recent FDA-related event for Avalyn Pharma occurred on June 17, 2026, involving AP01. The update was categorized as "Enrollment Update," with the company reporting: "Avalyn Pharma Inc announced that it has completed target enrollment of 375 patients in the Phase 2b MIST clinical trial of AP01 (inhaled pirfenidone) in patients with progressive pulmonary fibrosis (PPF). Additional patients currently in screening remain eligible for randomization and may be enrolled in the trial over the next several weeks." What conditions do Avalyn Pharma's current drugs treat? Currently, Avalyn Pharma has one therapy (AP01) targeting the following condition: Patients with Progressive Pulmonary Fibrosis. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events AngioDynamics FDA EventsAvalyn Pharma FDA EventsConnect Biopharma FDA EventsErnexa Therapeutics FDA EventsMIRA Pharmaceuticals FDA EventsNeonc Technologies FDA EventsOcular Therapeutix FDA EventsAvalo Therapeutics FDA EventsBioAge Labs FDA EventsBioMarin Pharmaceutical FDA EventsDiaMedica Therapeutics FDA EventsEdgewise Therapeutics FDA EventsFibroBiologics FDA EventsHCW Biologics FDA EventsOncobiologics FDA Events FDA Event Stage Terminology & Abbreviation Guide NDA: New Drug Application ANDA: Abbreviated New Drug Application sNDA: Supplemental New Drug Application BLA: Biologics License Application sBLA: Supplemental Biologics License Application FDA Approved: Approved by the FDA EMA: European Medicines Agency CE Mark: European Union Certification NMPA: China National Medical Products Administration MHLW: Japanese Ministry of Health FDA Meeting: Consultation with FDA Pre-IND: Pre-Investigational New Drug Meeting Breakthrough Therapy: Special FDA designation for promising therapies Fast Track: Accelerated FDA approval pathway Orphan Drug: Designation for rare disease treatments RPD: Rare Pediatric Disease Designation RMAT: Regenerative Medicine Advanced Therapy DSMB Review: Data Safety Monitoring Board Review IDMC Review: Independent Data Monitoring Committee MAA: MHRA Marketing Authorization Application RTF: Refusal to File (Rejected Application) 510(k): FDA Clearance for Medical Devices Rolling Submission: Staggered regulatory review process Related Companies Xenon Pharmaceuticals FDA Events CRISPR Therapeutics FDA Events Travere Therapeutics FDA Events Erasca FDA Events Tango Therapeutics FDA Events Oruka Therapeutics FDA Events Veradermics FDA Events Kiniksa Pharmaceuticals International FDA Events Catalyst Pharmaceuticals FDA Events ACADIA Pharmaceuticals FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NASDAQ:AVLN last updated on 6/17/2026 by MarketBeat.com Staff. 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Enrollment Update - June 17,2026Enrollment Update Drug: AP01Announced Date: June 17, 2026Indication: Patients with Progressive Pulmonary FibrosisAnnouncementAvalyn Pharma Inc announced that it has completed target enrollment of 375 patients in the Phase 2b MIST clinical trial of AP01 (inhaled pirfenidone) in patients with progressive pulmonary fibrosis (PPF). Additional patients currently in screening remain eligible for randomization and may be enrolled in the trial over the next several weeks.AI SummaryAvalyn Pharma Inc. said it has reached the planned enrollment target of 375 patients in its Phase 2b MIST clinical trial of AP01, an inhaled form of pirfenidone, for people with progressive pulmonary fibrosis (PPF). The study is testing two doses of AP01 against placebo in a global, randomized, double-blind design. MIST assigns patients in a 2:1:2 ratio to AP01 100 mg twice daily, AP01 50 mg twice daily, or placebo. The main goal is to see whether AP01 can improve or slow decline in lung function, measured by forced vital capacity, after 52 weeks. Avalyn said patients still in screening may continue to be enrolled over the next several weeks if they remain eligible.Read Announcement
