Athira Pharma (LONA) FDA Approvals $11.26 +0.26 (+2.36%) Closing price 05/15/2026 04:00 PM EasternExtended Trading$11.18 -0.08 (-0.75%) As of 05/15/2026 07:05 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Massive. Learn more. Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsInsider TradesSEC FilingsShort InterestTrendsBuy This Stock Athira Pharma's Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by Athira Pharma (LONA). Over the past two years, Athira Pharma has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Lasofoxifene. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. Lasofoxifene FDA Regulatory Events Lasofoxifene is a drug developed by Athira Pharma for the following indication: Treatment-Resistant ER+/HER2-, ESR1-Mutated Metastatic Breast Cancer. 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. Provided Update - April 23,2026Provided Update Drug: LasofoxifeneAnnounced Date: April 23, 2026Indication: Treatment-Resistant ER+/HER2-, ESR1-Mutated Metastatic Breast CancerAnnouncementLeonaBio, Inc. announced that it will host a virtual Key Opinion Leader event with two leading physician experts in the breast cancer field to discuss the current and evolving treatment landscape in metastatic breast cancer and the potential for lasofoxifene to transform the standard of care for patients with treatment-resistant estrogen receptor-positive (ER+), HER2-negative, ESR1-mutated metastatic breast cancer.AI SummaryLeonaBio announced a virtual Key Opinion Leader webinar on Wednesday, April 29, 2026 at 12:00 p.m. ET. Management will be joined by two leading breast cancer physician experts and David Portman, M.D., CEO of Sermonix Pharmaceuticals, to discuss the current and evolving treatment landscape in metastatic breast cancer and the potential for lasofoxifene to change the standard of care for patients with treatment‑resistant estrogen receptor‑positive (ER+), HER2‑negative, ESR1‑mutated metastatic disease. The event will review how lasofoxifene might address unmet needs in this resistant subgroup and the program’s path forward. LeonaBio noted that the ELAINE‑3 Phase 3 registrational study is expected to complete enrollment in the fourth quarter of 2026, with topline data anticipated in the second half of 2027. The live webcast will be available on LeonaBio’s website, and the archived event will be posted under Events in the Investor Relations section for later viewing.Read Announcement Athira Pharma FDA Events - Frequently Asked Questions Has Athira Pharma received FDA approval? As of now, Athira Pharma (LONA) has not received any FDA approvals for its therapy in the last two years. What drugs has Athira Pharma submitted to the FDA? In the past two years, Athira Pharma (LONA) has reported FDA regulatory activity for Lasofoxifene. What is the most recent FDA event for Athira Pharma? The most recent FDA-related event for Athira Pharma occurred on April 23, 2026, involving Lasofoxifene. The update was categorized as "Provided Update," with the company reporting: "LeonaBio, Inc. announced that it will host a virtual Key Opinion Leader event with two leading physician experts in the breast cancer field to discuss the current and evolving treatment landscape in metastatic breast cancer and the potential for lasofoxifene to transform the standard of care for patients with treatment-resistant estrogen receptor-positive (ER+), HER2-negative, ESR1-mutated metastatic breast cancer." What conditions do Athira Pharma's current drugs treat? Currently, Athira Pharma has one therapy (Lasofoxifene) targeting the following condition: Treatment-Resistant ER+/HER2-, ESR1-Mutated Metastatic Breast Cancer. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Amylyx Pharmaceuticals FDA EventsBelite Bio FDA EventsINmune Bio FDA EventsKymera Therapeutics FDA EventsLigand Pharmaceuticals FDA EventsNatera FDA EventsProtara Therapeutics FDA EventsTenaya Therapeutics FDA EventsUrogen Pharma FDA EventsAardvark Therapeutics FDA EventsAgenus FDA EventsApyx Medical FDA EventsAtossa Genetics FDA EventsBiogen FDA EventsBioLineRx 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 DiaMedica Therapeutics FDA Events Silence Therapeutics FDA Events Abeona Therapeutics FDA Events Compass Therapeutics FDA Events Immuneering FDA Events Palisade Bio FDA Events Organogenesis FDA Events C4 Therapeutics FDA Events Greenwich LifeSciences FDA Events Protara Therapeutics FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NASDAQ:LONA last updated on 4/23/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data. From Our PartnersSpaceX eyes a 1.75 trillion valuation - here's what to knowElon Musk's team has quietly filed confidential paperwork with the SEC for what Bloomberg estimates could be a...Brownstone Research | Sponsored$30 stock to buy before Starlink goes public (WATCH NOW!)In the next 3 minutes… James Altucher – legendary investor and venture capitalist… And someone who’s kno...Paradigm Press | SponsoredMy feud with Zohran MamdaniEmmy-winning analyst releases his next big story Whitney Tilson shocked the nation on 60 Minutes when he ac...Stansberry Research | SponsoredTrump's gold order: the announcement they won't put on the front pageOn August 15, 1971, Nixon interrupted prime-time television and ended the gold standard in 15 minutes - no deb...Reagan Gold Group | SponsoredIran War Shock: What I Was Told In That Private MeetingYou’re Being LIED To About The Iran War Forget EVERYTHING you’ve heard about the Iran war. Especially th...Banyan Hill Publishing | SponsoredWhy this tiny stock may move before the SpaceX IPO dropsThe projected SpaceX and xAI S-1 filing hits the SEC on June 1st - and analyst Dylan Jovine says $1.75 trillio...Behind the Markets | SponsoredSatellite Images Spot Potential $10 Trillion Discovery'Dark Energy': Elon Musk's Next Potential $10 Trillion Move A highly secure site in West Texas now houses a...Altimetry | SponsoredSpaceX Goes Public. Here's What Happens To Your IRA.When SpaceX goes public, fund managers will sell existing portfolio holdings to fund the move. Trillions in as...Americas Gold Company | Sponsored Adding Choose a watchlist: Watchlist Adding You have already added ten stocks to your watchlist. Upgrade to MarketBeat All Access to add more stocks to your watchlist. Adding Athira Pharma, Inc. Please log in to your account or sign up in order to add this asset to your watchlist. Share Athira Pharma With A Colleague Link copied to clipboard. Get 30 Days of MarketBeat All Access for Free Sign up for MarketBeat All Access to gain access to MarketBeat's full suite of research tools. Start Your 30-Day Trial MarketBeat All Access Features Best-in-Class Portfolio Monitoring Get personalized stock ideas. Compare portfolio to indices. Check stock news, ratings, SEC filings, and more. Stock Ideas and Recommendations See daily stock ideas from top analysts. Receive short-term trading ideas from MarketBeat. Identify trending stocks on social media. Advanced Stock Screeners and Research Tools Use our seven stock screeners to find suitable stocks. Stay informed with MarketBeat's real-time news. Export data to Excel for personal analysis. Sign in to your free account to enjoy these benefits In-depth profiles and analysis for 20,000 public companies. Real-time analyst ratings, insider transactions, earnings data, and more. Our daily ratings and market update email newsletter. Sign in to your free account to enjoy all that MarketBeat has to offer. Sign In Create Account Your Email Address: Email Address Required Your Password: Password Required Log In Email Me a Login Link or Sign in with Facebook Sign in with Google Forgot your password? Your Email Address: Please enter your email address. Please enter a valid email address Choose a Password: Please enter your password. Your password must be at least 8 characters long and contain at least 1 number, 1 letter, and 1 special character. Create My Account (Free) or Sign in with Facebook Sign in with Google By creating a free account, you agree to our terms of service. This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Provided Update - April 23,2026Provided Update Drug: LasofoxifeneAnnounced Date: April 23, 2026Indication: Treatment-Resistant ER+/HER2-, ESR1-Mutated Metastatic Breast CancerAnnouncementLeonaBio, Inc. announced that it will host a virtual Key Opinion Leader event with two leading physician experts in the breast cancer field to discuss the current and evolving treatment landscape in metastatic breast cancer and the potential for lasofoxifene to transform the standard of care for patients with treatment-resistant estrogen receptor-positive (ER+), HER2-negative, ESR1-mutated metastatic breast cancer.AI SummaryLeonaBio announced a virtual Key Opinion Leader webinar on Wednesday, April 29, 2026 at 12:00 p.m. ET. Management will be joined by two leading breast cancer physician experts and David Portman, M.D., CEO of Sermonix Pharmaceuticals, to discuss the current and evolving treatment landscape in metastatic breast cancer and the potential for lasofoxifene to change the standard of care for patients with treatment‑resistant estrogen receptor‑positive (ER+), HER2‑negative, ESR1‑mutated metastatic disease. The event will review how lasofoxifene might address unmet needs in this resistant subgroup and the program’s path forward. LeonaBio noted that the ELAINE‑3 Phase 3 registrational study is expected to complete enrollment in the fourth quarter of 2026, with topline data anticipated in the second half of 2027. The live webcast will be available on LeonaBio’s website, and the archived event will be posted under Events in the Investor Relations section for later viewing.Read Announcement
