$CGEM News

Last published 10h ago

10h agoCGEMNew Drug Application Submission Completed for Zipalertinib Plus Chemotherapy in First-Line EGFR Exon 20 Insertion Mutation Non-Small Cell Lung CancerGlobeNewswireSubmission is based on Phase 3 REZILIENT3 data in first-line EGFR ex20ins NSCLC...
2d agoCGEMSTIFEL 2026 HEALTHCARE CONFERENCE - CULLINAN THERAPEUTICS INCEarnings Call TranscriptsVery happy to have Colnan Therapeutics with us for the next Fireside Chat, CEO Nadeem Ahmed and Jeff Jones, CMO. Nadeim, do you want to kick it off with a brief overview of Colnan and then we'll get into the Q&A? Sure, y
2d agoCGEMCullinan Therapeutics, Inc. - EX-99.1Earnings ReleasesForm 8-K - Current report - Item 2.02 Item 9.01
3d agoCGEMCullinan Therapeutics to Participate in Upcoming Investor ConferencesGlobeNewswireCAMBRIDGE, Mass., Nov. 09, 2026 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (NASDAQ:CGEM, "Cullinan")), a clinical-stage biopharmaceutical company accelerating potential first- or best-in-class,
3d agoCGEMCullinan Therapeutics to Participate in Upcoming Investor ConferencesGlobeNewswireCAMBRIDGE, Mass., Nov. 09, 2026 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM; “Cullinan”), a clinical-stage biopharmaceutical company...
4d agoCGEMVelinotamig, a BCMAxCD3 T Cell Engager, Achieves Complete Renal Responses and Significantly Reduces Disease Activity in Systemic Lupus Erythematosus in Data Presented at ACR Convergence 2026GlobeNewswireClinically meaningful improvement in disease activity among 8 of 9 evaluable patients, including rapid and marked reductions in proteinuria with complete...
4d agoCGEMVelinotamig, a BCMAxCD3 T Cell Engager, Achieves Complete Renal Responses and Significantly Reduces Disease Activity in Systemic Lupus Erythematosus in Data Presented at ACR Convergence 2026GlobeNewswireClinically meaningful improvement in disease activity among 8 of 9 evaluable patients, including rapid and marked reductions in proteinuria with complete renal responses Deep and sustained reduction in pathogenic
1w agoCGEMCullinan Therapeutics Announces Presentations for CLN-049, a FLT3 T Cell Engager, and Velinotamig, a BCMA T Cell Engager, at the 68th ASH Annual MeetingGlobeNewswireCAMBRIDGE, Mass., Nov. 04, 2026 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (NASDAQ:CGEM), a clinical-stage biopharmaceutical company accelerating potential first- or best-in-class, disease-modifying T cell
2w agoCGEMCullinan Therapeutics Advances Velinotamig into Global Clinical Development for Autoimmune Cytopenias Following IND Clearance by the U.S. FDAGlobeNewswireGlobal regulatory clearances in the U.S. and Australia support initiation of a Phase 1b/2a study in relapsing and refractory ITP and wAIHA Study expands immunology portfolio into autoimmune cytopenias, evaluating a
3w agoCGEMZipalertinib Demonstrates Clinically Meaningful Intracranial Antitumor Activity in Patients with NSCLC with EGFR Exon 20 Insertion or Uncommon EGFR Mutations and Active CNS MetastasesBusiness WireIntracranial Objective Response Rate of 30.2% was observed in 43 evaluable patients Results to be shared in poster presentation at ESMO Congress 2026 Taiho Oncology, Inc. and Cullinan Therapeutics, Inc.
1mo agoCGEMCullinan Therapeutics Announces First Patient Dosed in Planned Registrational Phase 2 Study of CLN-049 in Relapsed/Refractory Acute Myeloid LeukemiaGlobeNewswireCAMBRIDGE, Mass., Oct. 08, 2026 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (NASDAQ:CGEM, "Cullinan")), a clinical-stage biopharmaceutical company accelerating potential first- or best-in-class,
1mo agoCGEMSTIFEL 2026 VIRTUAL IMMUNOLOGY AND INFLAMMATION FORUM - CULLINAN THERAPEUTICS INCEarnings Call TranscriptsHey, everyone. We're back. Really happy to have Colonin Therapeutics with us this afternoon for another Fireside. We have CEO Nadeem Ahmed and Jeff Jones, CMO, joining us. Maybe I'll kick it over to Nadeim for sort of a
1mo agoCGEMSTIFEL 2026 VIRTUAL IMMUNOLOGY AND INFLAMMATION FORUM - CULLINAN THERAPEUTICS INCEarnings Call TranscriptsHey, everyone. We're back. Really happy to have Colonin Therapeutics with us this afternoon for another Fireside. We have CEO Nadeem Ahmed and Jeff Jones, CMO, joining us. Maybe I'll kick it over to Nadeim for sort of a
1mo agoCGEMCullinan Therapeutics to Participate in the Stifel 2026 Virtual Immunology and Inflammation ForumGlobeNewswireCAMBRIDGE, Mass., Sept. 21, 2026 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (NASDAQ:CGEM, "Cullinan")), a clinical-stage biopharmaceutical company accelerating potential first- or best-in-class,
1mo agoCGEMZIPALERTINIB REZILIENT3 Results - CULLINAN THERAPEUTICS INCEarnings Call TranscriptsGood morning. Thank you for standing by, and welcome to the Cullinan Therapeutics Zip Alert and App Resilient 3 Results Conference Call. As a reminder, this call is being recorded. A slide deck that you may find helpful
1mo agoCGEMCullinan Therapeutics to Host Virtual Analyst and Investor Event Today to Feature Zipalertinib Plus Chemotherapy Phase 3 REZILIENT3 Data Presented at the IASLC 2026 World Conference on Lung CancerGlobeNewswireCAMBRIDGE, Mass., Sept. 14, 2026 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (NASDAQ:CGEM), a clinical-stage biopharmaceutical company accelerating potential first- or best-in-class, disease-modifying T cell
2mo agoCGEMZipalertinib Plus Chemotherapy Demonstrates 6-Month Median Progression-Free Survival Benefit in REZILIENT3 Phase 3 Trial in First-Line EGFR Exon 20 Insertion Mutation Non-Small Cell Lung CancerBusiness WireResults from the Phase 3 REZILIENT3 trial were featured in a Presidential Symposium at WCLC 2026 and demonstrated a statistically significant improvement in progression-free survival in first-line EGFR exon 20
2mo agoCGEMCullinan Therapeutics to Host Virtual Analyst and Investor Event to Showcase Zipalertinib Plus Chemotherapy Phase 3 REZILIENT3 Data Presented at the IASLC 2026 World Conference on Lung CancerGlobeNewswireResults from the planned interim analysis of the Phase 3 REZILIENT3 trial of zipalertinib plus chemotherapy in first-line EGFR exon 20 insertion mutation NSCLC to be presented in Presidential Symposium 2 on Sunday,
2mo agoCGEMZipalertinib Plus Chemotherapy First-Line Phase 3 REZILIENT3 Trial Data Selected for Presidential Symposium Presentation at the IASLC 2026 World Conference on Lung CancerBusiness WirePresentation will feature results from the planned interim analysis of the Phase 3 REZILIENT3 trial, which met its primary endpoint of progression-free survival in first line EGFR exon 20 insertion mutation
3mo agoCGEMZipalertinib Plus Chemotherapy Meets Primary Endpoint of Progression-Free Survival in Planned Interim Analysis of Phase 3 REZILIENT3 Trial in First-Line EGFR Exon 20 Insertion Mutation Non-Small Cell Lung CancerBusiness WireTaiho Oncology, Inc., Taiho Pharmaceutical Co., Ltd., and Cullinan Therapeutics, Inc. (NASDAQ:CGEM) today announced that the REZILIENT3 trial, a global Phase 3 clinical trial evaluating the combination of zipalertinib
3mo agoCGEMCullinan Therapeutics Provides Corporate Update and Reports Second Quarter 2026 Financial ResultsGlobeNewswireCLN-978 (CD19 TCE) multi-dose regimen data in RA in Q3 2026 and SLE in Q4 2026; Phase 2 expansion studies to begin early 2027 Velinotamig (BCMA TCE) multi-dose regimen data in SLE in Q4 2026; Phase 1/2 basket study in
3mo agoCGEMCullinan Therapeutics Announces Positive End-of-Phase 1 Meeting with FDA for CLN-049 and Advances Program to a Potentially Registrational Phase 2 Study in AMLGlobeNewswireCAMBRIDGE, Mass., July 28, 2026 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (NASDAQ:CGEM, "Cullinan")), a clinical-stage biopharmaceutical company accelerating potential first- or best-in-class,
5mo agoCGEMCullinan Therapeutics Shares New Clinical Data Across Its Portfolio of T Cell Engager Programs Targeting CD19 and BCMA in Autoimmune DiseasesGlobeNewswireCLN-978 (CD19 TCE) EULAR data demonstrated potential for immune reset, including remissions, in both systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA) CLN-978 data from the first RA multi-dose regimen
5mo agoCGEMCullinan Therapeutics Presents Initial Clinical Data for CLN-978, a CD19xCD3 T Cell Engager, at the EULAR 2026 CongressGlobeNewswireClinical benefit, including remissions, demonstrated in both systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA) patients following a single target dose of CLN-978 Deep, dose-dependent B cell depletion
5mo agoCGEMCullinan Therapeutics to Host Immunology Day to Showcase Promising Initial Clinical Data in Autoimmune Diseases for CLN-978, a CD19 T Cell Engager, and Velinotamig, a BCMA T Cell EngagerGlobeNewswireNew and updated clinical data to be presented from over 30 patients across systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA) studies Initial data from the first multi-dose cohort of RA study to be
5mo agoCGEMCullinan Therapeutics Receives FDA Orphan Drug Designation for CLN-049, a Novel FLT3xCD3 T Cell Engager, in Relapsed/Refractory Acute Myeloid LeukemiaGlobeNewswireOrphan Drug Designation underscores the potential of CLN-049, a novel FLT3xCD3 T cell engager, to address significant unmet need in AML CAMBRIDGE, Mass., May 19, 2026 (GLOBE NEWSWIRE) -- Cullinan Therapeutics,
5mo agoCGEMCullinan Therapeutics to Present Initial Clinical Data for CLN-978 in Treatment-Refractory Rheumatoid Arthritis and Systemic Lupus Erythematosus at EULAR 2026 CongressGlobeNewswireCAMBRIDGE, Mass., May 18, 2026 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (NASDAQ:CGEM), a clinical-stage biopharmaceutical company accelerating potential first- or best-in-class, high-impact therapies in
5mo agoARGX CGEM HYFT IDXX+2The Biology Came First.Business WireOver 20 partner-owned drug programs have reached clinical trials as a result of antibody discovery work performed by MindWalk scientists — ten currently in active Phase 1–3. The same scientific depth and biological
6mo agoCGEMCullinan Therapeutics Provides Corporate Update and Reports First Quarter 2026 Financial ResultsGlobeNewswireInitial clinical data in SLE and RA for CLN-978, a CD19 T cell engager, to be presented at the EULAR 2026 Congress in June; multi-dose regimen data in RA expected in Q3 2026 Zipalertinib NDA for relapsed EGFR ex20ins
6mo agoCGEMU.S. Food and Drug Administration Accepts New Drug Application for Zipalertinib for the Treatment of Locally Advanced or Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion MutationsBusiness WireNDA submission based on the Phase 2b REZILIENT1 clinical trial, which demonstrated clinically meaningful and durable responses in patients with relapsed EGFR exon 20 insertion–mutated NSCLC Prescription Drug User
8mo agoCGEMCullinan Therapeutics Provides Corporate Update and Reports Fourth Quarter and Full Year 2025 Financial ResultsGlobeNewswireInitial clinical data for CLN-978 in SLE and RA confirmed for Q2 2026; repeat dosing data in RA confirmed for Q3 2026 Zipalertinib rolling NDA submission completed; enrollment of REZILIENT3 frontline study completed
8mo agoCGEMCullinan Therapeutics to Participate in Upcoming Investor ConferencesGlobeNewswireCAMBRIDGE, Mass., Feb. 24, 2026 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (NASDAQ:CGEM, "Cullinan")), a clinical-stage biopharmaceutical company accelerating potential first- or best-in-class, high-impact
8mo agoCGEMCullinan Therapeutics to Participate in Fireside Chat at the Citi 2026 Virtual Oncology Leadership SummitGlobeNewswireCAMBRIDGE, Mass., Feb. 18, 2026 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (NASDAQ:CGEM, "Cullinan")), a clinical-stage biopharmaceutical company accelerating potential first- or best-in-class, high-impact
9mo agoAVBP SMMT MRUS MRK+9EGFR-NSCLC Market to Observe Stunning Growth at a CAGR of 9.6% During the Forecast Period (2025-2034) | DelveInsightPR NewswireDelveInsight's EGFR-NSCLC Market Insights report includes a comprehensive understanding of current treatment practices, EGFR-NSCLC emerging drugs,...
9mo agoCGEMCullinan Therapeutics to Participate in Fireside Chat at the Guggenheim Emerging Outlook: Biotech Summit 2026GlobeNewswireCAMBRIDGE, Mass., Feb. 05, 2026 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (NASDAQ:CGEM, "Cullinan")), a clinical-stage biopharmaceutical company accelerating potential first- or best-in-class, high-impact
10mo agoCGEMCullinan Therapeutics Provides Corporate Update and Highlights Anticipated 2026 MilestonesGlobeNewswireData readouts planned for CLN-978 across all three autoimmune indications in 2026, including single dose and repeat dosing data Company to complete monotherapy expansion cohorts to determine recommended Phase 2 dose
11mo agoCGEMCullinan Therapeutics Showcases Compelling Clinical Data in AML for CLN-049, Novel FLT3xCD3 T Cell Engager, in Oral Presentation at the 67th ASH MeetingGlobeNewswireCLN-049 monotherapy demonstrates promising efficacy, including multiple complete responses and encouraging response durability, in a heavily pretreated all-comer population of patients with R/R AML 31% CR/CRh rate
11mo agoCGEMCullinan Therapeutics Receives FDA Fast Track Designation for CLN-049, a Novel FLT3xCD3 T Cell Engager, in Relapsed/Refractory Acute Myeloid LeukemiaGlobeNewswirePromising efficacy and favorable safety data from the Phase 1 study in heavily pre-treated patients show potential of CLN-049 to address a broad population of AML patients CAMBRIDGE, Mass., Dec. 01, 2025 (GLOBE
11mo agoCGEMTaiho Oncology, Taiho Pharmaceutical and Cullinan Therapeutics Initiate Rolling Submission of New Drug Application to U.S. Food and Drug Administration for Zipalertinib for Treatment of Locally Advanced or Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion MutationsPR NewswireTaiho Oncology, Inc., Taiho Pharmaceutical Co., Ltd., and Cullinan Therapeutics, Inc. (Nasdaq: CGEM) today announced the companies have initiated the ...
1y agoCGEMCullinan Therapeutics to Participate in Upcoming Investor Conferences and Host Analyst and Investor Event at 2025 ASH Annual MeetingGlobeNewswireCAMBRIDGE, Mass., Nov. 10, 2025 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (NASDAQ:CGEM, "Cullinan")), a biopharmaceutical company accelerating potential high-impact therapies in autoimmune diseases and cancer,
1y agoCGEMCullinan Therapeutics Provides Corporate Update and Reports Third Quarter 2025 Financial ResultsGlobeNewswirePromising Phase 1 clinical data for CLN-049, a FLT3xCD3 bispecific T cell engager, demonstrating ~30% CRc rate in heavily pretreated, all-comer population of patients with relapsed/refractory AML to be presented in oral
1y agoCGEMCullinan Therapeutics to Showcase New Data Demonstrating Compelling Clinical Activity for CLN-049, a Novel FLT3xCD3 T Cell Engager, in AML Patients in an Oral Presentation at the 67th ASH Annual MeetingGlobeNewswireCLN-049 demonstrated anti-leukemic activity, including multiple complete responses, in a heavily pretreated population of patients with r/r AML, regardless of FLT3 mutational status ~30% CRc rate observed at clinically
1y agoCGEMCullinan Therapeutics Shares Additional Preclinical B Cell Depletion Data for CLN-978, Supporting Clinical Development Across Multiple Autoimmune Diseases, at ACR Convergence 2025GlobeNewswireCLN-978 led to rapid and deep B cell depletion in vitro and in vivo in multiple autoimmune diseases CAMBRIDGE, Mass., Oct. 25, 2025 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (NASDAQ:CGEM), a clinical-stage
1y agoCGEMTaiho Oncology and Cullinan Therapeutics Present Data on Zipalertinib in Patients with NSCLC with EGFR mutations and Active Brain Metastases at the ESMO Congress 2025PR NewswireTaiho Oncology, Inc., and Cullinan Therapeutics, Inc., today announced new data from the central nervous system (CNS) involvement cohort of the...
1y agoCGEMCullinan Therapeutics to Participate in Fireside Chat at the Stifel 2025 Virtual Immunology and Inflammation ForumGlobeNewswireCAMBRIDGE, Mass., Sept. 12, 2025 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (NASDAQ:CGEM, "Cullinan")), a biopharmaceutical company focused on developing modality-agnostic targeted therapies, today announced that
1y agoCGEMCullinan Therapeutics, Inc. (CGEM) Presents At Morgan Stanley 23rd Annual Global Healthcare Conference TranscriptEarnings Call Transcripts
1y agoCGEMTaiho Oncology and Cullinan Therapeutics Present Data on Zipalertinib at the IASLC 2025 World Conference on Lung CancerPR NewswireTaiho Oncology, Inc., and Cullinan Therapeutics, Inc., today announced new data from the REZILIENT1 and REZILIENT2 trials of zipalertinib, an oral...
1y agoCGEMCullinan Therapeutics to Participate in Upcoming Investor ConferencesGlobeNewswireCAMBRIDGE, Mass., Aug. 21, 2025 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (NASDAQ:CGEM, "Cullinan")), a biopharmaceutical company focused on developing modality-agnostic targeted therapies, today announced its
1y agoCGEMCullinan Therapeutics Provides Corporate Update and Reports Second Quarter 2025 Financial ResultsGlobeNewswireCLN-978 program now actively enrolling across Phase 1 studies in systemic lupus erythematosus (SLE), rheumatoid arthritis (RA) and Sjögren's disease BCMA-directed bispecific T cell engager velinotamig in-licensed from
1y agoCGEMTaiho Oncology and Cullinan Therapeutics Announce Acceptance of Abstracts for Zipalertinib at the IASLC 2025 World Conference on Lung CancerPR NewswireTaiho Oncology, Inc., and Cullinan Therapeutics, Inc., today announced the presentation of new data from zipalertinib REZILIENT1 and REZILIENT2...