Name in SEC filings: Cullinan Therapeutics, Inc.
| Program | Event | Stage | Stated timing | Filing |
|---|---|---|---|---|
| velinotamig | /data readout | Stage not stated | November 2026 | 8-K · |
| CLN-049 | Topline/data readout | Phase 1 | December 2026 | 8-K · |
| CLN-978 | Topline/data readout | Phase 1 | December 2026 | 8-K · |
| zipalertinib + platinum-based chemotherapy | submission | — | year-end 2026 | 8-K · |
| zipalertinib | target date (company stated) | PDUFA | February 27, 2027 | 8-K · |
Source: ORION, orionbiotechai.com/company/CGEM, data as of Oct 18, 2026
https://www.orionbiotechai.com/company/CGEM
velinotamig · Topline/data readout · November 2026
SEC sources last checked .
○ Quote matched to filing (not yet reviewed by founder) · ✓ Checked by founder.
Topline/data readoutNovember 2026
Stage: Not stated
Public float: $442,200,000 · as of · SEC filing
in a poster session at American College of Rheumatology Convergence 2026 in November.
SEC timing context:
On September 24, 2026, the Company outlined its plans to share the following immunology and oncology pipeline updates in the fourth quarter of 2026.
8-K · Filed · Last checked
Alert me · Calendar: same stage and window-end month (2026-11)
Topline/data readoutDecember 2026
Stage: Phase 1SEC filing · “Phase 1”
Public float: $442,200,000 · as of · SEC filing
The Company plans to share updated data from the dose escalation portion of its ongoing Phase 1 trial of CLN-049 in patients with relapsed/refractory acute myeloid leukemia in December.
SEC timing context:
On September 24, 2026, the Company outlined its plans to share the following immunology and oncology pipeline updates in the fourth quarter of 2026.
8-K · Filed · Last checked
Alert me · Calendar: same stage and window-end month (2026-12)
Topline/data readoutDecember 2026
Stage: Phase 1SEC filing · “Phase 1”
Public float: $442,200,000 · as of · SEC filing
The Company plans to share both multi-dose and single target dose regimen data from each of its ongoing Phase 1 clinical trials of CLN-978 in patients with (i) treatment-refractory moderate to severe systemic lupus erythematosus ("SLE"), (ii) difficult-to-treat rheumatoid arthritis ("RA") and (iii) treatment-refractory moderate to severe Sjögren's disease in December.
SEC timing context:
On September 24, 2026, the Company outlined its plans to share the following immunology and oncology pipeline updates in the fourth quarter of 2026.
8-K · Filed · Last checked
Alert me · Calendar: same stage and window-end month (2026-12)
NDA/BLA submissionyear-end 2026
Stage: —
Public float: $442,200,000 · as of · SEC filing
Completion of the Company's NDA submission is expected by year-end 2026.
8-K · Filed · Last checked
Alert me · Calendar: same stage and window-end month (2026-12)
PDUFA target date (company stated)February 27, 2027
Stage: PDUFASEC filing · “PDUFA) target action date”
Public float: $442,200,000 · as of · SEC filing
An NDA seeking accelerated approval for zipalertinib monotherapy in this indication remains under FDA review, with a Prescription Drug User Fee Act (PDUFA) target action date of February 27, 2027.
8-K · Filed · Last checked
Alert me · Calendar: same stage and window-end month (2027-02)
Company periods and sentences are quoted as written. A matching disclosure uses the SEC filing date for the same program and event type. As of .
| Program / event | Stated period and SEC wording | Disclosure in stated period |
|---|---|---|
| zipalertinibFDA decision | February 27, 2027“An NDA seeking accelerated approval for zipalertinib monotherapy in this indication remains under FDA review, with a Prescription Drug User Fee Act (PDUFA) target action date of February 27, 2027.” Filed · EX-99.1 | Period not started The stated period has not started yet, so there is nothing to compare. |
| zipalertinib + platinum-based chemotherapySubmission | year-end 2026“Completion of the Company's NDA submission is expected by year-end 2026.” Filed · 8-K | Still within period As of Oct 19, 2026 |
| CLN-049Clinical results | December 2026“The Company plans to share updated data from the dose escalation portion of its ongoing Phase 1 trial of CLN-049 in patients with relapsed/refractory acute myeloid leukemia in December.” Filed · 8-K | Period not started The stated period has not started yet, so there is nothing to compare. |
| CLN-978Clinical results | December 2026“The Company plans to share both multi-dose and single target dose regimen data from each of its ongoing Phase 1 clinical trials of CLN-978 in patients with (i) treatment-refractory moderate to severe systemic lupus erythematosus ("SLE"), (ii) difficult-to-treat rheumatoid arthritis ("RA") and (iii) treatment-refractory moderate to severe Sjögren's disease in December.” Filed · 8-K | Period not started The stated period has not started yet, so there is nothing to compare. |
| velinotamigClinical results | November 2026“in a poster session at American College of Rheumatology Convergence 2026 in November.” Filed · 8-K | Period not started The stated period has not started yet, so there is nothing to compare. |
| CLN-978Clinical results | 2026“• OUTRACE SjD o In Q4 2026, the Company plans to share initial data from the single target dose escalation portion of the study.” Filed · EX-99.1 | Not compared ORION has no confirmed start and end dates for this wording, so it is not compared with filings. |
| velinotamigClinical results | fourth quarter of 2026“Additional multi-dose regimen data from the trial are expected to be shared in the fourth quarter of 2026.” Filed · 10-Q | Not compared ORION has no confirmed start and end dates for this wording, so it is not compared with filings. |
| velinotamigClinical results | Q4 2026“Additional multi-dose regimen data from the study are expected to be shared in Q4 2026.” Filed · EX-99.1 | Not compared ORION has no confirmed start and end dates for this wording, so it is not compared with filings. |
| zipalertinibFDA decision | February 27, 2027“FDA assigned a Prescription Drug User Fee Act target action date of February 27, 2027.” Filed · 10-Q | Period not started The stated period has not started yet, so there is nothing to compare. |
| zipalertinibFDA decision | February 27, 2027“The Prescription Drug User Fee Act (PDUFA) target action date is February 27, 2027.” Filed · EX-99.1 | Period not started The stated period has not started yet, so there is nothing to compare. |
| velinotamigClinical results | fourth quarter of 2026“Additional multi-dose regimen data in patients with SLE” Filed · 8-K | Not compared ORION has no confirmed start and end dates for this wording, so it is not compared with filings. |
| zipalertinibFDA decision | February 27, 2027“The Prescription Drug User Fee Act target action date is February 27, 2027.” Filed · 10-Q | Period not started The stated period has not started yet, so there is nothing to compare. |
| zipalertinibFDA decision | February 27, 2027“The Prescription Drug User Fee Act (PDUFA) target action date is February 27, 2027.” Filed · EX-99.1 | Period not started The stated period has not started yet, so there is nothing to compare. |
“Not compared” means ORION has not matched this wording against a complete set of SEC filings for its period. It says nothing either way about whether a matching filing exists. Wording without exact dates is not given calendar dates.
Suggest an SEC timing statement to add for CGEM. You can include the original filing link in your note. The founder reads each request by hand.
Or email ORION.
See CGEM in the calendar · Review labels and methodology