Every material Form 8-K Cullinan Therapeutics, Inc. has filed with the SEC since September 24, 2026, read and summarized by AI: what happened, the key figures, whether it reads positive or negative for shareholders, and how big a deal it is (impact 1-5). Newest first; each brief links to its own page and to the filing on SEC.gov.
Cullinan Therapeutics furnished a press release and 8-K describing interim clinical data from a Phase 1b/2a trial of velinotamig in patients with refractory systemic lupus erythematosus. The trial is run by Genrix in China, and Cullinan holds the global (ex-Greater China) license, so the results bear on the company's lead clinical asset, though the data are early and based on a small number of patients.
As of the September 8, 2026 data cutoff, 12 patients had been treated across three multi-dose cohorts, with no dose-limiting toxicities and no ICANS reported
Cytokine release syndrome occurred in two patients, limited to Grade 1 or 2 events; no Grade 3 or higher CRS was observed
Eight of nine evaluable patients achieved a reduction of at least four points in SLEDAI-2K
Four of seven evaluable patients with proteinuria above 500 mg/24 hours at baseline achieved a complete renal response within 24 weeks
Cullinan Therapeutics disclosed updated Phase 1 dose escalation data for CLN-049, an investigational FLT3xCD3 T cell engager, in relapsed or refractory AML or MDS, and will present it at the 68th ASH Annual Meeting in December 2026. The data show an objective response rate of 45% at the 12 µg/kg target dose and cytokine release syndrome reduced to 26% under a two step-up dosing regimen, but the complete remission rates were 19% to 21% and the data come from a small, early-stage trial.
Study enrolled 87 patients (76 AML, 11 MDS) across 13 cohorts as of the data cutoff.
At 12 µg/kg, the CRc rate was 21% (6/29 patients, 2 CR) and the ORR was 45%; at 6 µg/kg, the CRc rate was 19% (3/16) and the ORR was 25%.
With a two step-up regimen, CRS incidence fell to 26% (7/27 patients) from 36% (13/36), and ICANS was 6% (5/87).
Cullinan Therapeutics announced on October 1, 2026 that it has initiated a New Drug Application submission to the FDA for zipalertinib plus platinum-based chemotherapy in previously untreated EGFR exon 20 insertion NSCLC, under the FDA's Real-Time Oncology Review program. The company expects to complete the submission by year-end 2026, and the filing does not disclose financial results or a change in guidance. For shareholders, this is a regulatory milestone that also keeps milestone payments from partner Taiho in view.
NDA submission initiated on October 1, 2026 under the FDA's Real-Time Oncology Review program; completion expected by year-end 2026
Submission is based on Phase 3 REZILIENT3 trial data, which met its primary endpoint for median progression-free survival
A separate NDA for zipalertinib monotherapy remains under FDA review with a PDUFA target action date of February 27, 2027
Company is eligible for a $30.0 million payment from Taiho on U.S. approval in second-line treatment and up to $100.0 million on first-line approval
Cullinan Therapeutics said it plans to share clinical data for three T cell engager programs in the fourth quarter of 2026, including velinotamig data at the ACR Convergence 2026 meeting in November and CLN-978 and CLN-049 updates in December. The filing is a pipeline timing update with no financial results, guidance, or financial figures, so it does not change the company's reported financial position.
Velinotamig multi-dose data in SLE to be presented in a poster session at ACR Convergence 2026 on November 8, 2026
CLN-978 multi-dose and single target dose data in SLE, RA, and Sjögren's disease planned for December
CLN-049 updated dose escalation data in relapsed/refractory AML planned for December, following a meeting with the FDA that the CEO called successful
Briefs are written by AI from the filing text and can contain mistakes — open the filing before acting on anything. Impact (1-5) and tone are the AI's reading of the filing for shareholders, not a price forecast. Not investment advice.
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