Exicure (XCUR) FDA Approvals $2.76 -0.23 (-7.69%) Closing price 04:00 PM EasternExtended Trading$2.74 -0.01 (-0.54%) As of 06:15 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 EventsHeadlinesInsider TradesOwnershipSEC FilingsShort InterestTrendsBuy This Stock Exicure's Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by Exicure (XCUR). Over the past two years, Exicure has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as burixafor. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. Burixafor FDA Regulatory Timeline and Events Burixafor is a drug developed by Exicure for the following indication: In Multiple Myeloma. 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 - February 5,2026Publication Phase 2Drug: burixaforAnnounced Date: February 5, 2026Indication: In Multiple MyelomaAnnouncementExicure, Inc. announced the publication of results from a prior Phase 2 clinical study evaluating burixafor (GPC-100/TG-0054), a highly selective CXCR4 inhibitor, in the journal Annals of Hematology.AI SummaryExicure, Inc. announced publication in the Annals of Hematology of Phase 2 results for burixafor (GPC-100/TG-0054), a selective CXCR4 inhibitor. In 12 participants, 11 (92%) collected ≥5.0 × 10^6 CD34+ cells/kg within two leukapheresis sessions; six did so in one session. Median neutrophil and platelet engraftment were 12 and 22 days. Burixafor was generally well tolerated, with only two treatment‑related adverse events reported, both low grade. Peak CD34+ mobilization occurred within one hour, much faster than CXCR4 inhibitors that typically peak at 10–14 hours. This could enable same‑day leukapheresis, simplify logistics, and reduce hospital resource use and patient burden. Combined with G‑CSF, burixafor caused marked rises in white blood cells; lymphocytes increased up to 11‑fold in multiple myeloma participants. These findings support potential use in gene therapy, CAR‑T, and gene‑editing workflows that need efficient peripheral blood cell collection.Read AnnouncementPoster Presentation - January 21,2026Poster Presentation Drug: burixaforAnnounced Date: January 21, 2026Indication: In Multiple MyelomaAnnouncementExicure, Inc. announced that it will present a poster at the upcoming 2026 Tandem Meetings | Transplantation & Cellular Therapy Meetings of the American Society for Transplantation and Cellular Therapy (ASTCT) and Center for International Blood and Marrow Transplant Research (CIBMTR), taking place February 4-7, 2026, in Salt Lake City, UT.Read AnnouncementPositive Results - December 8,2025Positive Results Phase 2Drug: burixaforAnnounced Date: December 8, 2025Indication: In Multiple MyelomaAnnouncementExicure, Inc. announced positive results from its completed Phase 2 trial evaluating burixafor (GPC-100) in combination with propranolol and granulocyte colony-stimulating factor (G-CSF) for the mobilization of hematopoietic progenitor cells (HPCs) in patients with multiple myeloma undergoing autologous hematopoietic cell transplantation (AHCT).AI SummaryExicure reported positive Phase 2 results of burixafor (GPC-100) given with propranolol and G-CSF to mobilize hematopoietic progenitor cells (HPCs) in multiple myeloma patients preparing for autologous transplant. In the open-label, multicenter study (NCT05561751) presented at ASH, 17 of 19 participants (89.5%) collected ≥2 × 10^6 CD34+ cells/kg within two leukapheresis sessions; two needed a third session. Among those who proceeded to transplant, median time to neutrophil engraftment was 13 days and to platelet engraftment 17.5 days. Burixafor blocks CXCL12 binding to CXCR4, rapidly moving stem cells into the blood, with peak CD34+ levels seen within one hour—enabling same-day dosing and apheresis. Propranolol appeared to boost mobilization via β2-adrenergic receptor inhibition. Sixteen participants had prior daratumumab; 14 of those (87.5%) met the primary endpoint, including 12 of 14 (85.7%) who had also received lenalidomide. The regimen was well tolerated, with no burixafor-related adverse events above Grade 2.Read AnnouncementProvided Update - October 6,2025Provided Update Drug: burixaforAnnounced Date: October 6, 2025Indication: In Multiple MyelomaAnnouncementExicure's ongoing Phase 2 study (NCT05561751) is a randomized, open-label, multicenter trial evaluating burixafor, a small molecule CXCR4 antagonist, in autologous stem cell transplant (ASCT) for multiple myeloma.AI SummaryExicure’s Phase 2 trial (NCT05561751) is testing burixafor, a small molecule CXCR4 antagonist, in autologous stem cell transplant for multiple myeloma. This randomized, open-label, multicenter study aims to boost stem cell collection by moving cells from bone marrow into the blood. So far, all 10 patients have met the main goal of collecting enough CD34+ stem cells, including those previously treated with daratumumab. Burixafor works faster than other agents and allows same-day administration of the mobilizing drug and leukapheresis. The drug has a well-tolerated safety profile with no serious side effects reported to date. This differs from FDA-approved options like plerixafor and motixafortide, which require overnight pre-treatment. Enrollment is complete, and the study database is locked. Exicure expects topline results in Q4 2025 and is preparing for a Phase 3 trial if the data support further testing. A full data report is planned.Read AnnouncementTop-line results - August 1,2025Top-Line Results Drug: burixaforAnnounced Date: August 1, 2025Target Action Date: Q4 2025Estimated Target Date Range: October 1, 2025 - December 31, 2025Indication: In Multiple MyelomaAnnouncementExicure, Inc. announced that the Topline results from the study are expected in the fourth quarter of 2025.AI SummaryExicure, Inc. announced that it has completed the last patient’s final visit in its Phase 2 clinical trial of GPC-100 (burixafor) combined with propranolol and G-CSF for multiple myeloma patients undergoing autologous stem cell transplant (ASCT). Topline results from this study are expected in the fourth quarter of 2025. The randomized, open-label, multicenter trial is designed to see if GPC-100 can boost CD34+ hematopoietic stem cell mobilization from the bone marrow into the blood, making collection by leukapheresis more efficient. Early data presented at ASH 2024 showed that GPC-100 mobilizes stem cells faster than current treatments. Investigators noted that, unlike traditional methods requiring an injection the night before collection, GPC-100 is given only 45 minutes ahead of the procedure. This shorter timeline may reduce logistical challenges and improve the experience for frail patients. Exicure is also planning a Phase 1 study in acute myeloid leukemia and exploring collaborations to use GPC-100’s rapid mobilization in cell and gene therapy settings.Read AnnouncementProvided Update - August 1,2025Provided Update Phase 2Drug: burixaforAnnounced Date: August 1, 2025Indication: In Multiple MyelomaAnnouncementExicure, Inc announced it has completed the last patient, last visit in its ongoing Phase 2 clinical trial (NCT05561751) evaluating the safety and efficacy of GPC-100 (burixafor) in combination with propranolol and G-CSF in multiple myeloma patients undergoing autologous stem cell transplant (ASCT).AI SummaryExicure, Inc. announced it has completed the last patient, last visit in its ongoing Phase 2 clinical trial (NCT05561751) of GPC-100 (burixafor) combined with propranolol and G-CSF in multiple myeloma patients undergoing autologous stem cell transplant (ASCT). Topline results are expected in the fourth quarter of 2025. The randomized, open-label, multicenter study is testing whether GPC-100, a small molecule CXCR4 antagonist, can boost CD34+ hematopoietic stem cell mobilization from bone marrow into the blood for collection by leukapheresis. Early data presented at ASH 2024 showed GPC-100 mobilizes stem cells faster than current approved treatments. Dr. Muthalagu Ramanathan of UMass Memorial Health noted that GPC-100 only needs to be given 45 minutes before stem cell collection, simplifying scheduling and easing the experience for frail myeloma patients. Exicure is also exploring GPC-100 in acute myeloid leukemia and cell and gene therapy settings.Read AnnouncementTop-line results - May 5,2025Top-Line Results Drug: burixaforAnnounced Date: May 5, 2025Target Action Date: H2 2025Estimated Target Date Range: July 1, 2025 - December 31, 2025Indication: In Multiple MyelomaAnnouncementExicure, Inc announced that Topline results expected H2 2025AI SummaryExicure, Inc. announced that topline results for its Phase 2 clinical trial are expected in the second half of 2025. The study is evaluating the safety and efficacy of GPC-100 (burixafor) in combination with propranolol and G-CSF for patients with multiple myeloma who are undergoing autologous stem cell transplant. GPC-100 is designed to improve the mobilization of hematopoietic stem cells, which is key for a successful transplant procedure. The efficient collection of stem cells can help reduce delays and additional procedures, benefiting both patients and healthcare providers. Exicure’s trial focuses on improving stem cell mobilization, and the upcoming results could lead to new treatment approaches for various indications. The company is also exploring additional studies and potential applications of GPC-100 in other blood disorders, further highlighting its commitment to advancing innovative therapies in hematologic diseases.Read AnnouncementEnrollment Completion - May 5,2025Enrollment Completion Phase 2Drug: burixaforAnnounced Date: May 5, 2025Indication: In Multiple MyelomaAnnouncementExicure, Inc. announced it has completed patient enrollment in its ongoing Phase 2 clinical trial (NCT05561751) evaluating the safety and efficacy of GPC-100 (burixafor) in combination with propranolol and G-CSF in multiple myeloma patients undergoing autologous stem cell transplant (ASCT).AI SummaryExicure, Inc. announced it has finished enrolling patients for its ongoing Phase 2 clinical trial (NCT05561751), which is testing the safety and effectiveness of GPC-100 (burixafor) combined with propranolol and G-CSF in multiple myeloma patients undergoing autologous stem cell transplant (ASCT). This randomized, open-label, multicenter study focuses on improving the collection of CD34+ hematopoietic stem cells by mobilizing them from the bone marrow to the peripheral blood. The goal is to enhance the efficiency of stem cell collection during treatment, which can reduce delays, decrease the number of apheresis sessions needed, and lower overall treatment costs. Topline results from the trial are expected in Fall 2025, and the study highlights the potential for GPC-100 to provide a safer and more effective stem cell mobilization option for patients undergoing ASCT.Read AnnouncementDose Update - April 14,2025Dose Update Phase 2Drug: burixaforAnnounced Date: April 14, 2025Indication: In Multiple MyelomaAnnouncementExicure, Inc announced that GPCR Therapeutics USA, a subsidiary of Exicure Inc., has dosed the 19th patient in its ongoing Phase 2 clinical trial evaluating GPC-100 (burixafor), a small molecule CXCR4 inhibitor, for the mobilization of stem cells in multiple myeloma (MM) patients undergoing autologous stem cell transplant (ASCT) (NCT05561751).AI SummaryExicure, Inc. announced that GPCR Therapeutics USA, a subsidiary of Exicure, has dosed the 19th patient in its ongoing Phase 2 clinical trial. The study is evaluating GPC-100 (burixafor), a small molecule CXCR4 inhibitor, for mobilizing stem cells in multiple myeloma patients undergoing autologous stem cell transplant. The trial, identified as NCT05561751, is open-label and multi-center, and it tests the safety and effectiveness of GPC-100 combined with propranolol and G-CSF. Preliminary results are promising, with all patients achieving successful CD34+ stem cell mobilization. Notably, GPC-100 allows for same-day administration of the treatment and leukapheresis, offering faster mobilization compared to other approved agents. The trial is on track to complete patient recruitment at the end of April.Read Announcement Exicure FDA Events - Frequently Asked Questions Has Exicure received FDA approval? As of now, Exicure (XCUR) has not received any FDA approvals for its therapy in the last two years. What drugs has Exicure submitted to the FDA? In the past two years, Exicure (XCUR) has reported FDA regulatory activity for burixafor. What is the most recent FDA event for Exicure? The most recent FDA-related event for Exicure occurred on February 5, 2026, involving burixafor. The update was categorized as "Publication," with the company reporting: "Exicure, Inc. announced the publication of results from a prior Phase 2 clinical study evaluating burixafor (GPC-100/TG-0054), a highly selective CXCR4 inhibitor, in the journal Annals of Hematology." What conditions do Exicure's current drugs treat? Currently, Exicure has one therapy (burixafor) targeting the following condition: In Multiple Myeloma. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Adagio Medical FDA EventsBioCardia FDA EventsCognition Therapeutics FDA EventsCorbus Pharmaceuticals FDA EventsPrecision BioSciences FDA EventsHUTCHMED FDA EventsEli Lilly and Company FDA EventsTeleflex FDA EventsBioMarin Pharmaceutical FDA EventsDiaMedica Therapeutics FDA EventsDyne Therapeutics FDA EventsGuardant Health FDA EventsLigand Pharmaceuticals FDA EventsMadrigal Pharmaceuticals FDA EventsMetaVia 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 Gossamer Bio FDA Events Spruce Biosciences FDA Events Gain Therapeutics FDA Events Seres Therapeutics FDA Events Pliant Therapeutics FDA Events PDS Biotechnology FDA Events Actuate Therapeutics FDA Events PMV Pharmaceuticals FDA Events Prima BioMed FDA Events MediciNova FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NASDAQ:XCUR last updated on 2/5/2026 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 | SponsoredIran's New Leader Just Said Something That Should Terrify Every AmericanIran's Supreme Leader has declared the Strait of Hormuz closed as leverage against the U.S. - and with 40% of ...American Alternative | 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 | 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 | 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 | 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 | SponsoredYour book attachedBill Poulos is giving away his 'Safe Trade Options Formula' book for free - but only for a limited time throug...Profits Run | 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 Exicure, Inc. Please log in to your account or sign up in order to add this asset to your watchlist. Share Exicure 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.
Publication - February 5,2026Publication Phase 2Drug: burixaforAnnounced Date: February 5, 2026Indication: In Multiple MyelomaAnnouncementExicure, Inc. announced the publication of results from a prior Phase 2 clinical study evaluating burixafor (GPC-100/TG-0054), a highly selective CXCR4 inhibitor, in the journal Annals of Hematology.AI SummaryExicure, Inc. announced publication in the Annals of Hematology of Phase 2 results for burixafor (GPC-100/TG-0054), a selective CXCR4 inhibitor. In 12 participants, 11 (92%) collected ≥5.0 × 10^6 CD34+ cells/kg within two leukapheresis sessions; six did so in one session. Median neutrophil and platelet engraftment were 12 and 22 days. Burixafor was generally well tolerated, with only two treatment‑related adverse events reported, both low grade. Peak CD34+ mobilization occurred within one hour, much faster than CXCR4 inhibitors that typically peak at 10–14 hours. This could enable same‑day leukapheresis, simplify logistics, and reduce hospital resource use and patient burden. Combined with G‑CSF, burixafor caused marked rises in white blood cells; lymphocytes increased up to 11‑fold in multiple myeloma participants. These findings support potential use in gene therapy, CAR‑T, and gene‑editing workflows that need efficient peripheral blood cell collection.Read Announcement
Poster Presentation - January 21,2026Poster Presentation Drug: burixaforAnnounced Date: January 21, 2026Indication: In Multiple MyelomaAnnouncementExicure, Inc. announced that it will present a poster at the upcoming 2026 Tandem Meetings | Transplantation & Cellular Therapy Meetings of the American Society for Transplantation and Cellular Therapy (ASTCT) and Center for International Blood and Marrow Transplant Research (CIBMTR), taking place February 4-7, 2026, in Salt Lake City, UT.Read Announcement
Positive Results - December 8,2025Positive Results Phase 2Drug: burixaforAnnounced Date: December 8, 2025Indication: In Multiple MyelomaAnnouncementExicure, Inc. announced positive results from its completed Phase 2 trial evaluating burixafor (GPC-100) in combination with propranolol and granulocyte colony-stimulating factor (G-CSF) for the mobilization of hematopoietic progenitor cells (HPCs) in patients with multiple myeloma undergoing autologous hematopoietic cell transplantation (AHCT).AI SummaryExicure reported positive Phase 2 results of burixafor (GPC-100) given with propranolol and G-CSF to mobilize hematopoietic progenitor cells (HPCs) in multiple myeloma patients preparing for autologous transplant. In the open-label, multicenter study (NCT05561751) presented at ASH, 17 of 19 participants (89.5%) collected ≥2 × 10^6 CD34+ cells/kg within two leukapheresis sessions; two needed a third session. Among those who proceeded to transplant, median time to neutrophil engraftment was 13 days and to platelet engraftment 17.5 days. Burixafor blocks CXCL12 binding to CXCR4, rapidly moving stem cells into the blood, with peak CD34+ levels seen within one hour—enabling same-day dosing and apheresis. Propranolol appeared to boost mobilization via β2-adrenergic receptor inhibition. Sixteen participants had prior daratumumab; 14 of those (87.5%) met the primary endpoint, including 12 of 14 (85.7%) who had also received lenalidomide. The regimen was well tolerated, with no burixafor-related adverse events above Grade 2.Read Announcement
Provided Update - October 6,2025Provided Update Drug: burixaforAnnounced Date: October 6, 2025Indication: In Multiple MyelomaAnnouncementExicure's ongoing Phase 2 study (NCT05561751) is a randomized, open-label, multicenter trial evaluating burixafor, a small molecule CXCR4 antagonist, in autologous stem cell transplant (ASCT) for multiple myeloma.AI SummaryExicure’s Phase 2 trial (NCT05561751) is testing burixafor, a small molecule CXCR4 antagonist, in autologous stem cell transplant for multiple myeloma. This randomized, open-label, multicenter study aims to boost stem cell collection by moving cells from bone marrow into the blood. So far, all 10 patients have met the main goal of collecting enough CD34+ stem cells, including those previously treated with daratumumab. Burixafor works faster than other agents and allows same-day administration of the mobilizing drug and leukapheresis. The drug has a well-tolerated safety profile with no serious side effects reported to date. This differs from FDA-approved options like plerixafor and motixafortide, which require overnight pre-treatment. Enrollment is complete, and the study database is locked. Exicure expects topline results in Q4 2025 and is preparing for a Phase 3 trial if the data support further testing. A full data report is planned.Read Announcement
Top-line results - August 1,2025Top-Line Results Drug: burixaforAnnounced Date: August 1, 2025Target Action Date: Q4 2025Estimated Target Date Range: October 1, 2025 - December 31, 2025Indication: In Multiple MyelomaAnnouncementExicure, Inc. announced that the Topline results from the study are expected in the fourth quarter of 2025.AI SummaryExicure, Inc. announced that it has completed the last patient’s final visit in its Phase 2 clinical trial of GPC-100 (burixafor) combined with propranolol and G-CSF for multiple myeloma patients undergoing autologous stem cell transplant (ASCT). Topline results from this study are expected in the fourth quarter of 2025. The randomized, open-label, multicenter trial is designed to see if GPC-100 can boost CD34+ hematopoietic stem cell mobilization from the bone marrow into the blood, making collection by leukapheresis more efficient. Early data presented at ASH 2024 showed that GPC-100 mobilizes stem cells faster than current treatments. Investigators noted that, unlike traditional methods requiring an injection the night before collection, GPC-100 is given only 45 minutes ahead of the procedure. This shorter timeline may reduce logistical challenges and improve the experience for frail patients. Exicure is also planning a Phase 1 study in acute myeloid leukemia and exploring collaborations to use GPC-100’s rapid mobilization in cell and gene therapy settings.Read Announcement
Provided Update - August 1,2025Provided Update Phase 2Drug: burixaforAnnounced Date: August 1, 2025Indication: In Multiple MyelomaAnnouncementExicure, Inc announced it has completed the last patient, last visit in its ongoing Phase 2 clinical trial (NCT05561751) evaluating the safety and efficacy of GPC-100 (burixafor) in combination with propranolol and G-CSF in multiple myeloma patients undergoing autologous stem cell transplant (ASCT).AI SummaryExicure, Inc. announced it has completed the last patient, last visit in its ongoing Phase 2 clinical trial (NCT05561751) of GPC-100 (burixafor) combined with propranolol and G-CSF in multiple myeloma patients undergoing autologous stem cell transplant (ASCT). Topline results are expected in the fourth quarter of 2025. The randomized, open-label, multicenter study is testing whether GPC-100, a small molecule CXCR4 antagonist, can boost CD34+ hematopoietic stem cell mobilization from bone marrow into the blood for collection by leukapheresis. Early data presented at ASH 2024 showed GPC-100 mobilizes stem cells faster than current approved treatments. Dr. Muthalagu Ramanathan of UMass Memorial Health noted that GPC-100 only needs to be given 45 minutes before stem cell collection, simplifying scheduling and easing the experience for frail myeloma patients. Exicure is also exploring GPC-100 in acute myeloid leukemia and cell and gene therapy settings.Read Announcement
Top-line results - May 5,2025Top-Line Results Drug: burixaforAnnounced Date: May 5, 2025Target Action Date: H2 2025Estimated Target Date Range: July 1, 2025 - December 31, 2025Indication: In Multiple MyelomaAnnouncementExicure, Inc announced that Topline results expected H2 2025AI SummaryExicure, Inc. announced that topline results for its Phase 2 clinical trial are expected in the second half of 2025. The study is evaluating the safety and efficacy of GPC-100 (burixafor) in combination with propranolol and G-CSF for patients with multiple myeloma who are undergoing autologous stem cell transplant. GPC-100 is designed to improve the mobilization of hematopoietic stem cells, which is key for a successful transplant procedure. The efficient collection of stem cells can help reduce delays and additional procedures, benefiting both patients and healthcare providers. Exicure’s trial focuses on improving stem cell mobilization, and the upcoming results could lead to new treatment approaches for various indications. The company is also exploring additional studies and potential applications of GPC-100 in other blood disorders, further highlighting its commitment to advancing innovative therapies in hematologic diseases.Read Announcement
Enrollment Completion - May 5,2025Enrollment Completion Phase 2Drug: burixaforAnnounced Date: May 5, 2025Indication: In Multiple MyelomaAnnouncementExicure, Inc. announced it has completed patient enrollment in its ongoing Phase 2 clinical trial (NCT05561751) evaluating the safety and efficacy of GPC-100 (burixafor) in combination with propranolol and G-CSF in multiple myeloma patients undergoing autologous stem cell transplant (ASCT).AI SummaryExicure, Inc. announced it has finished enrolling patients for its ongoing Phase 2 clinical trial (NCT05561751), which is testing the safety and effectiveness of GPC-100 (burixafor) combined with propranolol and G-CSF in multiple myeloma patients undergoing autologous stem cell transplant (ASCT). This randomized, open-label, multicenter study focuses on improving the collection of CD34+ hematopoietic stem cells by mobilizing them from the bone marrow to the peripheral blood. The goal is to enhance the efficiency of stem cell collection during treatment, which can reduce delays, decrease the number of apheresis sessions needed, and lower overall treatment costs. Topline results from the trial are expected in Fall 2025, and the study highlights the potential for GPC-100 to provide a safer and more effective stem cell mobilization option for patients undergoing ASCT.Read Announcement
Dose Update - April 14,2025Dose Update Phase 2Drug: burixaforAnnounced Date: April 14, 2025Indication: In Multiple MyelomaAnnouncementExicure, Inc announced that GPCR Therapeutics USA, a subsidiary of Exicure Inc., has dosed the 19th patient in its ongoing Phase 2 clinical trial evaluating GPC-100 (burixafor), a small molecule CXCR4 inhibitor, for the mobilization of stem cells in multiple myeloma (MM) patients undergoing autologous stem cell transplant (ASCT) (NCT05561751).AI SummaryExicure, Inc. announced that GPCR Therapeutics USA, a subsidiary of Exicure, has dosed the 19th patient in its ongoing Phase 2 clinical trial. The study is evaluating GPC-100 (burixafor), a small molecule CXCR4 inhibitor, for mobilizing stem cells in multiple myeloma patients undergoing autologous stem cell transplant. The trial, identified as NCT05561751, is open-label and multi-center, and it tests the safety and effectiveness of GPC-100 combined with propranolol and G-CSF. Preliminary results are promising, with all patients achieving successful CD34+ stem cell mobilization. Notably, GPC-100 allows for same-day administration of the treatment and leukapheresis, offering faster mobilization compared to other approved agents. The trial is on track to complete patient recruitment at the end of April.Read Announcement