Avalyn Pharma (AVLN) FDA Approvals $28.92 -0.02 (-0.07%) As of 07/9/2026 04:00 PM Eastern Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsHeadlinesInsider TradesSEC FilingsTrendsBuy 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. 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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
