Cullinan Therapeutics Soars 11.59% on Clinical Trial Progress

On April 8, 2025, Cullinan Therapeutics' stock surged by 11.59% in pre-market trading, reflecting significant investor optimism and market confidence in the company's recent developments and future prospects.

Cullinan Therapeutics has been actively advancing its clinical trials and drug development programs. The company recently announced that it expects initial clinical data from its global Phase 1 study of CLN-978 in Systemic Lupus Erythematosus (SLE) to be available in the fourth quarter of 2025. This development is crucial as CLN-978 is the first and only development-stage CD19 T cell engager in its category, positioning Cullinan at the forefront of innovative treatments for autoimmune diseases.

In addition to its progress with CLN-978, Cullinan Therapeutics has also made significant strides in its oncology portfolio. The company, in collaboration with Taiho Pharmaceutical and Taiho Oncology, announced that the primary endpoint was met in a Phase 2b trial of Zipalertinib for patients with non-small cell lung cancer harboring EGFR Exon 20 insertion mutations. This achievement underscores the efficacy and safety of Zipalertinib, further bolstering investor confidence in Cullinan's pipeline.

Cullinan's recent FDA clearance for an Investigational New Drug (IND) application for CLN-978, administered subcutaneously in patients with moderate to severe SLE, is another milestone. This clearance allows the company to proceed with its global Phase 1 clinical trial, which is designed to assess the safety, pharmacokinetics, and initial clinical activity of CLN-978. The positive data from the pivotal Phase 2b REZILIENT1 study of Zipalertinib also highlights the company's commitment to developing targeted therapies for cancer patients.