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Cullinan Therapeutics, Inc.Bullish
Cullinan Therapeutics has initiated the New Drug Application (NDA) submission process for zipalertinib in combination with chemotherapy for NSCLC under the FDA's Real-Time Oncology Review (RTOR) program. The submission is supported by positive Phase 3 REZILIENT3 trial results and is expected to be completed by the end of 2026.…more
Cullinan Therapeutics, Inc.
Cullinan Therapeutics has confirmed its plans to release key clinical data for its immunology and oncology pipeline in the fourth quarter of 2026. The company will present Phase 1 data for velinotamig in SLE in November, followed by data for CLN-978 in SLE, RA, and Sjögren’s disease, as well as updated Phase 1 data for CLN-049 in AML in December.…more
Cullinan Therapeutics, Inc.
Cullinan Therapeutics announced that the Phase 3 REZILIENT3 trial met its primary endpoint, with the combination of zipalertinib and chemotherapy demonstrating a median progression-free survival (PFS) of 14.5 months compared to 8.5 months for chemotherapy alone. These results confirm the clinical efficacy of the combination therapy as a first-line treatment for patients with EGFR exon 20 insertion-positive non-small cell lung cancer.…more
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Cullinan Therapeutics Reports Positive Intracranial Activity for Zipalertinib in NSCLC Trial…more
Cullinan Therapeutics announced that its Phase 2 trial for zipalertinib demonstrated clinically meaningful intracranial antitumor activity in patients with EGFR-mutated NSCLC and active CNS metastases. The results support the continued development of the drug as a potential treatment for this difficult-to-treat patient population.…more
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Cullinan Therapeutics has initiated dosing for the first patient in its registrational Phase 2 study of CLN-049, a T cell engager for relapsed/refractory acute myeloid leukemia. This study marks a key step in the company's clinical development pipeline following discussions with the FDA.…more
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Cullinan Therapeutics has begun the FDA submission process for its lung cancer drug following successful Phase 3 trial results. The company expects to complete the NDA filing by the end of 2026.…more
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