Stock Taper 
Cullinan Therapeutics, Inc., a Cambridge-based clinical-stage biopharmaceutical company founded in 2016, develops oncology and immuno-oncology therapies, including CLN-978, CLN-619, and others.
Zipalertinib is an investigational oral inhibitor targeting EGFR exon 20 insertion-mutant NSCLC, with Taiho Oncology submitting a rolling NDA to the FDA for accelerated approval, expected in early 2026.
In November 2025, Cullinan Therapeutics and its partners, Taiho Oncology and Taiho Pharmaceutical, initiated a rolling New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) for zipalertinib. The submission seeks accelerated approval for the treatment of patients with locally advanced or metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations who have received prior chemotherapy. This key regulatory step, which followed a Breakthrough Therapy Designation, generated significant investor interest and was reported to have caused a more than 38% increase in the company's stock price.
In a significant strategic shift during its third quarter of 2025, Cullinan Therapeutics announced the discontinuation of two clinical-stage oncology programs, CLN-619 and CLN-617. This decision allows the company to reallocate resources and focus on its more promising T cell engager programs for autoimmune diseases and acute myeloid leukemia.
In the Phase 3 REZILIENT3 study, zipalertinib combination therapy demonstrated longest median progression-free survival observed to date in first-line EGFR exon20ins NSCLC
I think Cullinan Therapeutics' recent pullback is a compelling price entry ahead of their clinical updates. CGEM has scheduled updates for its autoimmune pipeline for December 2026. The combined CLN-978 results could help corroborate its earlier data. Additionally, if CLN-978 becomes viable for more patients with a manageable safety profile, the potential repeat dosing also seems promising for better efficacy.
Cullinan Therapeutics NASDAQ: CGEM outlined upcoming clinical milestones across its immunology and oncology pipeline, including a planned December update for its CD19-directed T-cell engager CLN-978 and data presentations for other programs in November and the fourth quarter.
Overall rating: C
| PEER | PRICE | |
|---|---|---|
 OMER | $18.61 | COMPARE |
 CBLL | $23.69 | COMPARE |
 VREX | $18.46 | COMPARE |
 SY | $2.75 | COMPARE |
 LAB | $0.74 | COMPARE |
 BCYC | $3.38 | COMPARE |
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 NMRA | $0.50 | COMPARE |
