Partner Therapeutics announces submission of supplemental Biologics License Application (sBLA) to FDA for BIZENGRI® (zenocutuzumab-zbco) in NRG1 Fusion Positive Cholangiocarcinoma and Inclusion in updated NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®)

 

Lexington, MA – April 14, 2026 – Partner Therapeutics, Inc. (PTx), a private, fully integrated biotechnology company, announces the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for BIZENGRI (zenocutuzumab-zbco), seeking approval for the treatment of adults with advanced unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 (NRG1) gene fusion. Cholangiocarcinoma is a rare, aggressive malignancy of the bile ducts with few effective treatment options. There are no approved therapies specifically targeting ...

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Zenocutuzumab-zbco Granted FDA Breakthrough Therapy Designation for NRG1+ Cholangiocarcinoma; Data Highlighting Potential of Zenocutuzumab-zbco in NRG1+ Cholangiocarcinoma to be Presented at AACR-NCI-EORTC

• Investigational treatment with zenocutuzumab-zbco in adults with advanced unresectable or metastatic NRG1+ cholangiocarcinoma showed a 37% ORR, median time to response of 1.9 months, and median duration of response of 7.4 months

Lexington, MA – Oct. 23, 2025 – Partner Therapeutics, Inc. (PTx), a private, fully-integrated biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) to zenocutuzumab-zbco for the treatment of adults with advanced unresectable or ...

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BARDA and Partner Therapeutics continue partnership around development of LEUKINE® (sargramostim, rhu GM-CSF) to potentially improve patient care for sepsis

 

Lexington, MA – January 9, 2025 /PRNewswire/ – Partner Therapeutics, Inc. (PTx) today announced a collaboration with the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services to fund a phase 2 study in patients with sepsis to assess the safety and enable dose selection of LEUKINE (sargramostim, rhu GM-CSF). The partners also will evaluate monocyte human leukocyte antigen-DR (mHLA-DR) and other ...

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