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Home › PDUFA Calendar › CGEM

Cullinan Therapeutics, Inc. (CGEM) FDA catalysts & readout calendar

Page updated ·next FDA decision on the calendar ·Data as of Oct 16, 2026 12:20 PM ET
Cullinan Therapeutics, Inc. · 1 upcoming · 1 past FDA decision

Upcoming FDA catalysts

CGEM · Feb 27, 2027CLN-081: Non Small Cell Lung Cancer

FDA decision history (1)

Oct 13, 2025unverifiedFDA decision

Clinical readouts (2)

2026-11CLN-0812026-09CLN-081

Conference presentations (1)

Sep 12, 2026Zipalertinib (with Taiho Oncology) at IASLC World Conference on Lung Cancer (Presidential Symposium oral)
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This page aggregates CGEM's FDA catalysts from pdufa.bio's own calendar and decision archive. Each item links to its source page. Facts and dates only; verify against primary FDA / SEC / company filings.

CGEM run-up, measured

Computed from this stock's own daily closing prices, on the same T-120 basis as the run-up study: the baseline is the close 120 trading sessions before the eve of the decision. These are measurements of what already happened, not predictions.

Run-up so far, this catalyst
Since its T-120 baseline on 2026-09-04 ($22.09), CGEM is -39.3% to $13.40 at the close on 2026-10-16. The highest close since that baseline is +0.0% above it.
30 of 120 sessions elapsed, 90 to go. Cohort context: across 1,875 past decisions the median peak from T-120 was 18.1% and the median move to the day before the decision was 2.4%.
CGEM's past FDA decisions (n=1)
DecisionOutcomeT-120 to eveT-120 to peak
2025-10-13CRL-8.6%+12.1%
With only one decision on record, no median is shown: an average of 1 event would not be a meaningful statistic. The individual figures above are exact. For a statistical base see the run-up study, built on 1,875 decisions.

Common questions

When is the next FDA decision or readout for Cullinan Therapeutics, Inc. (CGEM)?

November 2026. The next catalyst for Cullinan Therapeutics, Inc. is CLN-081 (readout). That date is known to the month only. One further catalyst is scheduled after it. Dates are taken from FDA notices, company filings or ClinicalTrials.gov, and we do not publish a specific day when the source only gives a month or a quarter.

Has Cullinan Therapeutics, Inc. (CGEM) had an FDA decision before?

Yes, 1 in our archive: 0 approval(s) and 1 Complete Response Letter(s). The most recent was on October 13, 2025 and was a Complete Response Letter. Each one has its own page with the source document and the share-price reaction we measured.

How has CGEM stock moved into its FDA decisions?

Measured from this company's own daily closing prices: Since its T-120 baseline on 2026-09-04 ($22.09), CGEM is -39.3% to $13.40 at the close on 2026-10-16. The highest close since that baseline is +0.0% above it. These are historical measurements of what already happened, not forecasts, and we publish no price targets or probability of approval.

Where does this CGEM data come from?

FDA publications, company filings with the SEC, company press releases and ClinicalTrials.gov, with share prices measured from daily closing data. Every date and outcome links the document it came from. Where an outcome was inferred from the price reaction rather than read from a filing, the page says so on its face.