Eikon Therapeutics (EIKN) FDA Approvals $8.12 +0.12 (+1.44%) As of 03:04 PM Eastern This is a fair market value price provided by Massive. Learn more. Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsInsider TradesNews and TrendsOwnershipSEC FilingsShort Interest Eikon Therapeutics' Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by Eikon Therapeutics (EIKN). Over the past two years, Eikon Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as EIK1001. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. EIK1001 FDA Regulatory Timeline and Events EIK1001 is a drug developed by Eikon Therapeutics for the following indication: patients with stage IV NSCLC. 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. Publication - October 18,2026Publication Drug: EIK1001Announced Date: October 18, 2026Indication: patients with stage IV NSCLCAnnouncementEikon Therapeutics, Inc announced the publication of full-text abstracts from its four clinical candidates to be presented at the 2026 European Society for Medical Oncology (ESMO) Congress in Madrid, Spain beginning on October 23, 2026..Read AnnouncementDose Update - August 11,2026Dose Update Drug: EIK1001Announced Date: August 11, 2026Indication: patients with stage IV NSCLCAnnouncementEikon Therapeutics, Inc. announced the selection of a dose of 0.60 mg/m2 that will be employed in future for all patients randomized to receive EIK1001 in the TeLuRide-006 trial.Read AnnouncementDose Update - July 27,2026Dose Update Phase 2/3Drug: EIK1001Announced Date: July 27, 2026Indication: patients with stage IV NSCLCAnnouncementEikon Therapeutics, Inc. announced that the first patient has been dosed in TeLuRide-008, a Phase 2/3 registrational study evaluating EIK1001 in combination with pembrolizumab and histology-appropriate chemotherapy as first-line therapy for treatment-naïve patients with stage 4 Non-Small Cell Lung Cancer (NSCLC).AI SummaryEikon Therapeutics, Inc. announced that the first patient has been dosed in TeLuRide-008, a Phase 2/3 registrational clinical trial of EIK1001. The study is evaluating EIK1001 in combination with pembrolizumab and chemotherapy selected for the patient’s cancer type. It is designed for patients with newly diagnosed, stage 4 non-small cell lung cancer (NSCLC) who have not previously received treatment for advanced disease. The trial will assess whether this combination can provide a meaningful treatment option for people with advanced NSCLC. As a registrational study, its results could support future regulatory applications if the treatment is shown to be safe and effective. Eikon noted that statements about the trial and EIK1001’s potential are forward-looking and involve risks and uncertainties. The company said these statements reflect information available at the time of the announcement and may not be updated unless required by law.Read AnnouncementAbstract - July 20,2026Abstract Drug: EIK1001Announced Date: July 20, 2026Indication: patients with stage IV NSCLCAnnouncementEikon Therapeutics, Inc. announced the acceptance of seven abstracts covering progress across its lead programs at the 2026 European Society of Medical Oncology (ESMO) Congress in Madrid, Spain.AI SummaryEikon Therapeutics announced that seven abstracts from its clinical pipeline were accepted for presentation at the 2026 European Society of Medical Oncology (ESMO) Congress in Madrid. The updates cover several lead programs, including EIK1001, EIK1003, EIK1004, and EIK1005, across a range of cancers. For EIK1001, the company will share Phase 2 results in stage IV non-small cell lung cancer, including data from the squamous cohort, as well as a Phase 2/3 study combining the drug with pembrolizumab and chemotherapy. EIK1003 data will include studies in metastatic prostate cancer and advanced solid tumors. EIK1004 will be presented as a first-in-human study in patients with advanced solid tumors carrying HRR mutations. EIK1005 presentations will cover its use as a monotherapy and with pembrolizumab, along with safety, tolerability, and pharmacokinetic findings. The company said the abstracts reflect progress across its pipeline, but noted that forward-looking statements should not be relied on too heavily.Read Announcement Eikon Therapeutics FDA Events - Frequently Asked Questions Has Eikon Therapeutics received FDA approval? As of now, Eikon Therapeutics (EIKN) has not received any FDA approvals for its therapy in the last two years. What drugs has Eikon Therapeutics submitted to the FDA? In the past two years, Eikon Therapeutics (EIKN) has reported FDA regulatory activity for EIK1001. What is the most recent FDA event for Eikon Therapeutics? The most recent FDA-related event for Eikon Therapeutics occurred on October 18, 2026, involving EIK1001. The update was categorized as "Publication," with the company reporting: "Eikon Therapeutics, Inc announced the publication of full-text abstracts from its four clinical candidates to be presented at the 2026 European Society for Medical Oncology (ESMO) Congress in Madrid, Spain beginning on October 23, 2026.." What conditions do Eikon Therapeutics' current drugs treat? Currently, Eikon Therapeutics has one therapy (EIK1001) targeting the following condition: patients with stage IV NSCLC. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Arbutus Biopharma FDA EventsAcumen Pharmaceuticals FDA EventsCognition Therapeutics FDA EventsCorbus Pharmaceuticals FDA EventsDiaMedica Therapeutics FDA EventsGilead Sciences FDA EventsSCYNEXIS FDA EventsSciSparc FDA EventsAbbVie FDA EventsMedtronic FDA EventsTeleflex FDA EventsAchieve Life Sciences FDA EventsBioCryst Pharmaceuticals FDA EventsHeartBeam FDA EventsCardiff Oncology 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 Stoke Therapeutics FDA Events Immunocore FDA Events uniQure FDA Events Ultragenyx Pharmaceutical FDA Events Ascentage Pharma Group International FDA Events Omeros FDA Events Hemab Therapeutics FDA Events Kailera Therapeutics FDA Events AnaptysBio FDA Events Nektar Therapeutics FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare Stocks FDA progress for NASDAQ:EIKN last updated on 10/19/2026 by MarketBeat.com Staff. 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Publication - October 18,2026Publication Drug: EIK1001Announced Date: October 18, 2026Indication: patients with stage IV NSCLCAnnouncementEikon Therapeutics, Inc announced the publication of full-text abstracts from its four clinical candidates to be presented at the 2026 European Society for Medical Oncology (ESMO) Congress in Madrid, Spain beginning on October 23, 2026..Read Announcement
Dose Update - August 11,2026Dose Update Drug: EIK1001Announced Date: August 11, 2026Indication: patients with stage IV NSCLCAnnouncementEikon Therapeutics, Inc. announced the selection of a dose of 0.60 mg/m2 that will be employed in future for all patients randomized to receive EIK1001 in the TeLuRide-006 trial.Read Announcement
Dose Update - July 27,2026Dose Update Phase 2/3Drug: EIK1001Announced Date: July 27, 2026Indication: patients with stage IV NSCLCAnnouncementEikon Therapeutics, Inc. announced that the first patient has been dosed in TeLuRide-008, a Phase 2/3 registrational study evaluating EIK1001 in combination with pembrolizumab and histology-appropriate chemotherapy as first-line therapy for treatment-naïve patients with stage 4 Non-Small Cell Lung Cancer (NSCLC).AI SummaryEikon Therapeutics, Inc. announced that the first patient has been dosed in TeLuRide-008, a Phase 2/3 registrational clinical trial of EIK1001. The study is evaluating EIK1001 in combination with pembrolizumab and chemotherapy selected for the patient’s cancer type. It is designed for patients with newly diagnosed, stage 4 non-small cell lung cancer (NSCLC) who have not previously received treatment for advanced disease. The trial will assess whether this combination can provide a meaningful treatment option for people with advanced NSCLC. As a registrational study, its results could support future regulatory applications if the treatment is shown to be safe and effective. Eikon noted that statements about the trial and EIK1001’s potential are forward-looking and involve risks and uncertainties. The company said these statements reflect information available at the time of the announcement and may not be updated unless required by law.Read Announcement
Abstract - July 20,2026Abstract Drug: EIK1001Announced Date: July 20, 2026Indication: patients with stage IV NSCLCAnnouncementEikon Therapeutics, Inc. announced the acceptance of seven abstracts covering progress across its lead programs at the 2026 European Society of Medical Oncology (ESMO) Congress in Madrid, Spain.AI SummaryEikon Therapeutics announced that seven abstracts from its clinical pipeline were accepted for presentation at the 2026 European Society of Medical Oncology (ESMO) Congress in Madrid. The updates cover several lead programs, including EIK1001, EIK1003, EIK1004, and EIK1005, across a range of cancers. For EIK1001, the company will share Phase 2 results in stage IV non-small cell lung cancer, including data from the squamous cohort, as well as a Phase 2/3 study combining the drug with pembrolizumab and chemotherapy. EIK1003 data will include studies in metastatic prostate cancer and advanced solid tumors. EIK1004 will be presented as a first-in-human study in patients with advanced solid tumors carrying HRR mutations. EIK1005 presentations will cover its use as a monotherapy and with pembrolizumab, along with safety, tolerability, and pharmacokinetic findings. The company said the abstracts reflect progress across its pipeline, but noted that forward-looking statements should not be relied on too heavily.Read Announcement
