Athira Pharma (LONA) FDA Approvals $8.22 -0.39 (-4.53%) Closing price 06/5/2026 04:00 PM EasternExtended Trading$8.23 +0.01 (+0.12%) As of 06/5/2026 04:10 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 BioCardia FDA EventsClimb Bio FDA EventsAxsome Therapeutics FDA EventsBiogen FDA EventsFate Therapeutics FDA EventsGH Research FDA EventsIncyte FDA EventsJazz Pharmaceuticals FDA EventsLyell Immunopharma FDA EventsMoleculin Biotech FDA EventsMirum Pharmaceuticals FDA EventsNextCure FDA EventsPharming Group FDA EventsRegeneron Pharmaceuticals FDA EventsTravere Therapeutics 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 Abeona Therapeutics FDA Events Rocket Pharmaceuticals FDA Events Adherex Technologies FDA Events Humacyte FDA Events Cellectis FDA Events Amarin FDA Events DiaMedica Therapeutics FDA Events Silence Therapeutics FDA Events Organogenesis FDA Events Immuneering 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. 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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
