Cullinan Therapeutics Receives FDA Fast Track Designation for CLN-049, a Novel FLT3xCD3 T Cell Engager, in Relapsed/Refractory Acute Myeloid Leukemia
Cullinan Oncology, Inc. (CGEM)
NASDAQ:AMEX Investor Relations:
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Source: GlobeNewswire
Promising efficacy and favorable safety data from the Phase 1 study in heavily pre-treated patients show potential of CLN-049 to address a broad population of AML patients CAMBRIDGE, Mass., Dec. 01, 2025 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM), a clinical-stage biopharmaceutical company accelerating potential first- or best-in-class, high-impact therapies in autoimmune diseases and cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to CLN-049 for the treatment of relapsed/refractory (R/R) acute myeloid leukemia (AML). Data from the Phase 1 clinical trial of CLN-049 will be presented at the upcoming 67th American Society of Hematology (ASH) Annual Meeting and Exposition in an oral presentation on December 8. “Fast Track designation underscores both the urgent need for new options in relapsed and refractory acute myeloid leukemia and the promise of CLN-049,” said Jeffrey Jones, MD, MBA, Chief Medical Off
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News
- Cullinan Therapeutics (NASDAQ:CGEM) had its "buy" rating reaffirmed by analysts at HC Wainwright.MarketBeat
- Cullinan Therapeutics (NASDAQ:CGEM) had its "overweight" rating reaffirmed by analysts at Morgan Stanley.MarketBeat
- Cullinan Therapeutics Provides Corporate Update and Highlights Anticipated 2026 MilestonesGlobeNewswire
- Cullinan Therapeutics (NASDAQ:CGEM) had its price target raised by analysts at Wedbush from $25.00 to $34.00. They now have an "outperform" rating on the stock.MarketBeat
- Cullinan Therapeutics Showcases Compelling Clinical Data in AML for CLN-049, Novel FLT3xCD3 T Cell Engager, in Oral Presentation at the 67th ASH MeetingGlobeNewswire
CGEM
Earnings
- 11/6/25 - Beat
CGEM
Sec Filings
- 1/8/26 - Form 8-K
- 1/5/26 - Form 4
- 12/29/25 - Form 4
- CGEM's page on the SEC website