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Cullinan Therapeutics to Host Immunology Day to Showcase Promising Initial Clinical Data in Autoimmune Diseases for CLN-978, a CD19 T Cell Engager, and Velinotamig, a BCMA T Cell Engager

Tue, 26 May 2026 07:00:00 -0400

New and updated clinical data to be presented from over 30 patients across systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA) studies

Initial data from the first multi-dose cohort of RA study to be presented

Initial data from the first multi-dose cohort of velinotamig study also to be shared

Leading key opinion leaders Dr. Ricardo Grieshaber-Bouyer and Dr. John Tesser to share clinical perspectives

The Company will host the in-person event for analysts and institutional investors on Wednesday, June 10, starting at 8:30 a.m. ET in New York City

CAMBRIDGE,

Cullinan Therapeutics to Host Immunology Day to Showcase Promising Initial Clinical Data in Autoimmune Diseases for CLN-978, a CD19 T Cell Engager, and Velinotamig, a BCMA T Cell Engager

Tue, 26 May 2026 07:00:00 -0400

New and updated clinical data to be presented from over 30 patients across systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA) studies

Initial data from the first multi-dose cohort of RA study to be presented

Initial data from the first multi-dose cohort of velinotamig study also to be shared

Leading key opinion leaders Dr. Ricardo Grieshaber-Bouyer and Dr. John Tesser to share clinical perspectives

The Company will host the in-person event for analysts and institutional investors on Wednesday, June 10, starting at 8:30 a.m. ET in New York City

CAMBRIDGE,

Cullinan Therapeutics receives FDA orphan drug status for leukemia drug

Tue, 19 May 2026 07:01:00 -0400

Cullinan Therapeutics Inc. (NASDAQ: CGEM) announced that the U.S. Food and Drug Administration granted Orphan Drug Designation to CLN-049 for treating relapsed/refractory acute myeloid leukemia.

CLN-049 is an investigational FLT3xCD3 T cell engager designed to target FLT3-expressing leukemia cells. The drug binds to both mutated and non-mutated FLT3, enabling targeted action regardless of FLT3 mutational status.

The FDA's Orphan Drug Designation applies to drugs intended to treat rare diseases affecting fewer than 200,000 people in the United States. The designation provides development incentives including tax credits for clinical trials, exemption from certain FDA user fees, and potential seven-year market exclusivity following approval.

"FDA

Cullinan Therapeutics receives FDA orphan drug status for leukemia drug

Tue, 19 May 2026 07:01:00 -0400

Cullinan Therapeutics Inc. (NASDAQ: CGEM) announced that the U.S. Food and Drug Administration granted Orphan Drug Designation to CLN-049 for treating relapsed/refractory acute myeloid leukemia.

"FDA

Cullinan Therapeutics Receives FDA Orphan Drug Designation for CLN-049, a Novel FLT3xCD3 T Cell Engager, in Relapsed/Refractory Acute Myeloid Leukemia

Tue, 19 May 2026 07:00:00 -0400

Orphan Drug Designation underscores the potential of CLN-049, a novel FLT3xCD3 T cell engager, to address significant unmet need in AML

CAMBRIDGE, Mass., May 19, 2026 (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 Orphan Drug Designation to CLN-049, a novel, investigational FLT3xCD3 T cell engager, for the treatment of relapsed/refractory (R/R) acute myeloid leukemia (AML).

“FDA Orphan Drug Designation for CLN-049 emphasizes both the

Cullinan Therapeutics Receives FDA Orphan Drug Designation for CLN-049, a Novel FLT3xCD3 T Cell Engager, in Relapsed/Refractory Acute Myeloid Leukemia

Tue, 19 May 2026 07:00:00 -0400

Orphan Drug Designation underscores the potential of CLN-049, a novel FLT3xCD3 T cell engager, to address significant unmet need in AML

“FDA Orphan Drug Designation for CLN-049 emphasizes both the

Cullinan Oncology (CGEM) Reiterated at Buy by Stifel on CLN-978 Data

Tue, 19 May 2026 06:51:21 -0400

Stifel analyst Alex Thompson reiterated a Buy rating and $28.00 price target on Cullinan Oncology Inc. (NASDAQ: CGEM).

The analyst commented, "The ABSTRACT for the CLN-978 (CD19xCD3 TCE) data at EULAR on 6/6 was posted. Data with a cut-off of 1/14/26 included 9 SLE and 5 RA patients across 3 cohorts. Details are limited, though note that only GR1 CRS occurred within 24hrs of the 10mcg step up dose with no CRS at a target dose and no ICANs. B-cell depletion appears to trend towards a dose response with trends of clinical activity in both SLE and RA. Of note, no

Cullinan Therapeutics to Present Initial Clinical Data for CLN-978 in Treatment-Refractory Rheumatoid Arthritis and Systemic Lupus Erythematosus at EULAR 2026 Congress

Mon, 18 May 2026 17:00:00 -0400

CAMBRIDGE, Mass., May 18, 2026 (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 initial clinical data from two ongoing Phase 1 studies evaluating CLN-978, a subcutaneously administered CD19xCD3 T cell engager, will be presented at the European Alliance of Associations for Rheumatology (EULAR) European Congress of Rheumatology being held June 3-6, 2026 in London, United Kingdom.