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Cullinan Therapeutics
CGEM.US
Cullinan Therapeutics, Inc., a clinical-stage biopharmaceutical company, develops therapies for autoimmune diseases and cancer in the United States. The company develops zipalertinib, a bioavailable small molecule in Phase 3 trial for the treatment of patients with non-small cell lung cancer; CLN-978, a T cell engager to treat systemic lupus erythematosus and rheumatoid arthritis; and CLN-619, a monoclonal antibody in Phase 1 trial for the treatment of solid tumors and multiple myeloma. Its development products also include CLN-049, a humanized bispecific antibody in Phase 1 trial for the treatment of acute myeloid leukemia (AML) or myelodysplastic syndrome, as well as measurable residual disease positive AML; and CLN-617, a fusion protein in Phase 1 trial for the treatment of solid tumors. It has a collaboration agreement with Adimab, LLC to discover and/or optimize antibodies; and co-development agreement with Taiho Pharmaceutical Co., Ltd to develop zipalertinib.
1.875 T
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    News
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    Optimistic Buy Rating for Cullinan Management Driven by Promising Drug Pipeline and Upcoming Catalysts

    Analyst Robert Burns from H.C. Wainwright reiterated a Buy rating for Cullinan Management, raising the price target to $26 due to promising drug pipeline developments and upcoming catalysts. The company, in collaboration with Taiho Oncology, is advancing a New Drug Application for zipalertinib, supported by positive trial results. Upcoming catalysts include Phase 1 results for CLN-049. Despite potential risks, the outlook remains optimistic. JonesTrading also maintained a Buy rating with a $34 target.

    Tip Ranks·
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    CGEM
    +3.20%
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    Taiho Oncology, Taiho Pharmaceutical And Cullinan Therapeutics initiate rolling submission of new drug application to US FDA

    Nov 20 (Reuters) - Cullinan Therapeutics Inc:TAIHO ONCOLOGY, TAIHO PHARMACEUTICAL AND CULLINAN THERAPEUTICS INITIATE ROLLING SUBMISSION OF NEW DRUG APPLICATION TO U.S. FOOD AND DRUG ADMINISTRATION FOR ZIPALERTINIB FOR TREATMENT OF LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER WITH EGFR EXON 20 INSERTION MUTATIONSTAIHO ONCOLOGY INC: ANTICIPATE COMPLETION OF NDA SUBMISSION IN Q1 2026 WITH ASSOCIATED REQUEST FOR PRIORITY REVIEW Source text: Further company coverage:

    Reuters·
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    +3.20%
    Reuters·
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    +3.20%

    Cullinan Therapeutics and Partners Begin FDA Rolling Submission for Zipalertinib in EGFR-Mutant NSCLC

    Cullinan Therapeutics Inc., in collaboration with Taiho Oncology and Taiho Pharmaceutical, has started a rolling submission of a New Drug Application (NDA) to the FDA for zipalertinib. The drug targets EGFR-mutant NSCLC and seeks accelerated approval based on positive Phase 1/2 trial results. The submission is expected to be completed in Q1 2026, including a request for priority review.

    Reuters·
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    Cullinan Management’s Promising Pipeline and Strategic Collaborations Drive Buy Rating

    Soumit Roy from JonesTrading has maintained a Buy rating on Cullinan Management with a price target of $34.00, citing promising developments in its pipeline, including the CLN-978 T-cell engager in Phase 1 trials and collaboration with Taiho on the Zipalertinib program. Initial data for CLN-978 is expected in 2026, while a New Drug Application filing for Zipalertinib is anticipated by the end of 2025. H.C. Wainwright also reiterated a Buy rating with a $24.00 price target, reflecting confidence in Cullinan's innovative therapies.

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    CGEM
    +3.20%
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    +3.20%

    Cullinan Therapeutics to Host Analyst and Investor Event at ASH Annual Meeting

    Cullinan Therapeutics Inc. will host an in-person event for analysts and institutional investors on December 8, 2025, during the ASH Annual Meeting in Orlando, FL. This event will follow an oral presentation of Phase 1 study results of CLN-049 in AML or MDS patients earlier that morning.

    Reuters·
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