Avalyn Pharma (AVLN) FDA Approvals $37.62 +0.23 (+0.62%) As of 04:00 PM Eastern Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsInsider TradesNews and TrendsOwnershipSEC FilingsShort Interest 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. New Data - September 8,2026New Data Drug: AP01Announced Date: September 8, 2026Indication: Patients with Progressive Pulmonary FibrosisAnnouncementAvalyn Pharma Inc. announced new data demonstrating predicted aerosol distribution of AP01 and survey data highlighting patient perspectives on participation in clinical studies for idiopathic pulmonary fibrosis (IPF).Read AnnouncementEnrollment 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 September 8, 2026, involving AP01. The update was categorized as "New Data," with the company reporting: "Avalyn Pharma Inc. announced new data demonstrating predicted aerosol distribution of AP01 and survey data highlighting patient perspectives on participation in clinical studies for idiopathic pulmonary fibrosis (IPF)." 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 Artiva Biotherapeutics FDA EventsAvalyn Pharma FDA EventsBriacell Therap FDA EventsBeam Therapeutics FDA EventsBioAge Labs FDA EventsBioVie FDA EventsBelite Bio FDA EventsDefinium Therapeutics FDA EventsDyne Therapeutics FDA EventsMonte Rosa Therapeutics FDA EventsNkarta FDA EventsIntellia Therapeutics FDA EventsQuoin Pharmaceuticals FDA EventsRoivant Sciences FDA EventsUpstream Bio 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 Belite Bio FDA Events Liquidia FDA Events Definium Therapeutics FDA Events Veradermics FDA Events Organon & Co. FDA Events MBX Biosciences FDA Events Tarsus Pharmaceuticals FDA Events Arcutis Biotherapeutics FDA Events Atai Beckley FDA Events Supernus Pharmaceuticals FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare Stocks FDA progress for NASDAQ:AVLN last updated on 9/8/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data. From Our PartnersThis looks like plywood. It's not.AI data centers have a power problem nobody likes to talk about. A single rack of computers can now use more e...Eagle Publishing | SponsoredModerna’s 177% Surge Puts Cancer Biotech Back in FocusModerna shares surged 177% in a single trading session on August 19, adding about $45 billion in market value ...The Tomorrow Investor | SponsoredThey're not buying gold. They're buying this.Bank of America raised its stake in a small gold company by 139%. 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New Data - September 8,2026New Data Drug: AP01Announced Date: September 8, 2026Indication: Patients with Progressive Pulmonary FibrosisAnnouncementAvalyn Pharma Inc. announced new data demonstrating predicted aerosol distribution of AP01 and survey data highlighting patient perspectives on participation in clinical studies for idiopathic pulmonary fibrosis (IPF).Read Announcement
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
