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Cullinan Therapeutics, Inc. develops clinical-stage therapies for autoimmune diseases and cancer, with a pipeline centered on T cell engagers and targeted oncology programs. Recurring news includes updates on CLN-978, a CD19xCD3 T cell engager for autoimmune diseases; velinotamig, a BCMAxCD3 program; CLN-049, a FLT3xCD3 bispecific T cell engager for relapsed or refractory AML and MDS; and zipalertinib for EGFR exon 20 insertion-mutated non-small cell lung cancer.
Company announcements commonly cover clinical data presentations, regulatory submissions and FDA communications, portfolio prioritization, collaborations involving zipalertinib, quarterly financial results, cash runway commentary and healthcare investor conference participation.
Cullinan Therapeutics (Nasdaq: CGEM), together with Taiho Oncology and Taiho Pharmaceutical, reported that the global Phase 3 REZILIENT3 trial in first-line EGFR exon 20 insertion mutation non-small cell lung cancer met its primary endpoint of progression-free survival at a planned interim analysis. Zipalertinib plus platinum-based chemotherapy showed a statistically significant and clinically meaningful improvement in progression-free survival versus chemotherapy alone, with manageable safety, leading the Independent Data Monitoring Committee to recommend unblinding. The open-label trial enrolled 285 previously untreated adults with locally advanced or metastatic non-squamous NSCLC. The companies plan to present full data at a future medical conference and, following discussions with the FDA, pursue U.S. regulatory approval for zipalertinib plus chemotherapy in this first-line setting. Zipalertinib remains an investigational, oral, next-generation irreversible EGFR inhibitor and is not approved by any health authority.
Cullinan Therapeutics (Nasdaq: CGEM) reported second quarter 2026 results and detailed clinical and regulatory milestones across its immunology and oncology T cell engager pipeline. CLN-978 in SLE and RA will deliver additional multi-dose data in Q3–Q4 2026, with Phase 2 expansions planned for early 2027, and initial Sjögren’s disease data expected in Q4 2026. Velinotamig multi-dose data in SLE are also expected in Q4 2026, ahead of a planned global Phase 1/2 basket study in autoimmune cytopenias in early 2027.
In oncology, a potentially registrational Phase 2 CLN-049 study in relapsed/refractory AML is set to begin in Q3 2026, with a combination Phase 1/2 trial planned in Q4 2026. The FDA has accepted the NDA for zipalertinib in EGFR ex20ins NSCLC, with a PDUFA date of February 27, 2027. According to Cullinan, cash and investments totaled $356 million as of June 30, 2026, providing runway into 2029, while Q2 2026 R&D expenses were $44.4 million, G&A $12.8 million, and net loss $53.7 million.
Cullinan Therapeutics (Nasdaq: CGEM) reported positive feedback from the U.S. FDA following an End-of-Phase 1 meeting for CLN-049, a FLT3xCD3 T cell engager in acute myeloid leukemia (AML). Based on this interaction, Cullinan plans to start a potentially registrational Phase 2 study in relapsed/refractory AML in Q3 2026, using a design that includes a short dose-optimization phase and seamless transition to a single-arm cohort at the recommended Phase 2 dose.
CLN-049 has shown promising clinical activity and a favorable safety profile in relapsed/refractory AML and holds Orphan Drug and Fast Track designations for this indication. Cullinan expects an update from the dose-escalation portion of the ongoing Phase 1 trial in Q4 2026 and plans a Phase 1/2 combination study with venetoclax and azacitidine in previously untreated AML. CLN-049 targets FLT3-expressing leukemia cells, including both mutated and non-mutated FLT3, and is also being evaluated in AML with measurable residual disease and in myelodysplastic syndrome.
Cullinan Therapeutics (Nasdaq: CGEM) reported new clinical data for its T cell engagers CLN-978 (CD19xCD3) and velinotamig (BCMAxCD3) in autoimmune diseases.
Results included clinical remissions and deep B cell depletion in refractory SLE and RA, complete renal responses in lupus nephritis, favorable safety, and defined timelines for further data and Phase 2a expansions through 2027.
Cullinan Therapeutics (Nasdaq: CGEM) reported initial Phase 1 data for CLN-978, a CD19xCD3 T cell engager, in refractory SLE and difficult-to-treat RA at EULAR 2026.
Among 29 patients, single-dose treatment showed clinical activity, deep B cell depletion in blood and tissue, and a generally manageable safety profile up to 30 µg. Further multi-dose data are expected at Immunology Day on June 10.
Cullinan Therapeutics (Nasdaq: CGEM) will host an in-person Immunology Day for analysts and institutional investors on June 10, 2026, at 8:30 a.m. ET in New York City.
The event will showcase new and updated clinical data for CLN-978 in systemic lupus erythematosus and rheumatoid arthritis, and velinotamig in treatment‑refractory autoimmune diseases driven by long‑lived plasma cells, including first multi‑dose cohort results and global development plans.
Cullinan Therapeutics (Nasdaq: CGEM) announced that the FDA granted Orphan Drug Designation to CLN-049, an investigational FLT3xCD3 T cell engager, for treating relapsed/refractory acute myeloid leukemia (AML). According to Cullinan, this recognizes the unmet need in AML, including TP53-mutated disease, and aligns with promising Phase 1 results.
Cullinan Therapeutics (Nasdaq: CGEM) will present initial Phase 1 clinical data for CLN-978, a subcutaneous CD19xCD3 T cell engager, at the EULAR 2026 Congress in London on June 3-6, 2026.
Data from the OUTRACE RA and OUTRACE SLE studies in treatment-refractory rheumatoid arthritis (RA) and moderate to severe systemic lupus erythematosus (SLE) show single target doses with a favorable safety profile at initial dose levels, robust B cell depletion in blood and tissue, and early signals of clinical activity. Updated data, including additional patients, will be shared in Poster POS1179 on June 6, 2026.
MindWalk Holdings (NASDAQ: HYFT) reported that over 20 drug candidates in partner pipelines originated from its antibody discovery work, with 10 programs now in active Phase 1–3 clinical trials across oncology, immunology, neurology, and infectious disease.
The company highlighted its HYFT® and LensAI™ biological intelligence infrastructure, built on a Knowledge Graph indexing 660 million biological patterns and 25 billion relationships, and a record of 400+ peer-reviewed publications and patents supporting collaborations with firms such as Annexon, argenx, Xencor, Cullinan Oncology, and others.
Cullinan Therapeutics (Nasdaq: CGEM) reported first-quarter 2026 results and provided a corporate update on clinical and regulatory milestones. Cash, cash equivalents, short- and long-term investments, and interest receivable were $393.3 million as of March 31, 2026, providing runway into 2029. Key near-term clinical readouts include initial single-dose CLN-978 data in SLE and RA to be presented at EULAR on June 6, 2026, CLN-049 dose-escalation updates in H2 2026 and RP2D by Q4 2026, and velinotamig multi-dose data in Q4 2026. The U.S. FDA accepted an NDA for zipalertinib with a PDUFA date of February 27, 2027; Cullinan is eligible for up to $130 million in U.S. regulatory milestone payments and a 50/50 U.S. profit share.