CGEM SEC Filings, Earnings & Splits

Cullinan Therapeutics announced positive interim Phase 1b/2a clinical data for velinotamig in patients with active, refractory, moderate-to-severe systemic lupus erythematosus (SLE), showing a favorable safety profile and clinical activity across disease activity, serologic markers, and renal function measures.

Cullinan Therapeutics announced updated Phase 1 dose escalation data for CLN-049 in relapsed/refractory AML and MDS, showing a two step-up dosing regimen reduced cytokine release syndrome incidence and severity while demonstrating anti-leukemic activity, with the program advancing to an ongoing Phase 2 trial.

Cullinan Therapeutics announced the initiation of a New Drug Application (NDA) submission to the FDA for zipalertinib in combination with platinum-based chemotherapy for first-line treatment of EGFR exon 20 insertion NSCLC under the Real-Time Oncology Review program, with completion expected by year-end 2026.

Cullinan Therapeutics announced anticipated immunology and oncology pipeline milestones for Q4 2026, including data readouts for CLN-978, velinotamig, and CLN-049.

Cullinan Therapeutics announced positive Phase 3 REZILIENT3 trial results for zipalertinib plus chemotherapy in first-line EGFR ex20ins NSCLC, showing significant improvement in progression-free survival (14.5 vs 8.5 months, HR 0.50).

An institutional holder filed an amended Schedule 13G for Cullinan Therapeutics, Inc. (CGEM), indicating a change in beneficial ownership position.

A Schedule 13G was filed indicating a passive ownership position in Cullinan Therapeutics, Inc. The filing text provided contains only the EDGAR directory listing and does not disclose the holder's identity, ownership percentage, or share count.

Cullinan Therapeutics announced that its global Phase 3 REZILIENT3 trial of zipalertinib plus chemotherapy met the primary endpoint of progression-free survival in first-line NSCLC with EGFR exon 20 insertion mutations, with plans to pursue U.S. regulatory approval.