Eikon Therapeutics (EIKN) FDA Approvals $9.73 +0.44 (+4.74%) As of 04:00 PM Eastern Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsHeadlinesOwnershipSEC FilingsShort InterestTrendsBuy This Stock 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 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. 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 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 July 27, 2026, involving EIK1001. The update was categorized as "Dose Update," with the company reporting: "Eikon 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)." What conditions do Eikon Therapeutics' current drugs treat? Currently, Eikon Therapeutics has one therapy (EIK1001) targeting the following condition: patients with stage IV NSCLC. 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Common Stock FDA Events Lakefront Biotherapeutics American Depositary Shares FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare Stocks FDA progress for NASDAQ:EIKN last updated on 7/27/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data. 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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
