First Targeted Therapy Approved for NRG1+ Cholangiocarcinoma

BIZENGRI Now Approved for Patients Harboring NRG1 Gene Fusions in Non-small Cell Lung Cancer, Pancreatic Adenocarcinoma, and Cholangiocarcinoma

LEXINGTON, Mass. – May 11, 2026 – Partner Therapeutics, Inc. (PTx), a private, fully integrated biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) has approved BIZENGRI^® (zenocutuzumab-zbco) for the treatment of adults with advanced, unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior ...

Voucher Recognizes High Unmet Medical Need in Ultra-Rare, Molecularly Defined Cholangiocarcinoma  

LEXINGTON, Mass. – May 06, 2026 – Partner Therapeutics, Inc. (PTx), a private, fully integrated biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) has awarded a Commissioner’s National Priority Voucher (CNPV) pilot program voucher for BIZENGRI^® (zenocutuzumab-zbco) for the treatment of adults with advanced, unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic ...

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 ...

LEXINGTON, Mass.—February 20, 2026—Partner Therapeutics, Inc. (PTx) announced findings from a post hoc analysis of the eNRGy trial (NCT02912949) evaluating treatment beyond progression with zenocutuzumab in patients with advanced neuregulin 1 fusion-positive (NRG1+) non-small cell lung cancer (NSCLC). Results were presented at the 2026 International Association for the Study of Lung Cancer (IASLC) Targeted Therapies of Lung Cancer (TTLC) meeting. NRG1+ NSCLC is associated with low response rates and poor outcomes with non-targeted therapies, underscoring the need for effective targeted treatment ...

Designation strengthens BIZENGRI® development program in rare cholangiocarcinoma

LEXINGTON, Mass. —February 5, 2026—Partner Therapeutics, Inc. (PTx), a privately held, fully integrated biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to zenocutuzumab‑zbco for the treatment of adults with advanced unresectable or metastatic cholangiocarcinoma. Zenocutuzumab-zbco is being developed in a subset of patients with cholangiocarcinoma harboring a neuregulin 1 (NRG1) gene fusion.

Cholangiocarcinoma (CCA) is a rare, aggressive malignancy of the bile ducts, typically ...

Lexington, MA – January 9, 2026 – Partner Therapeutics, Inc. (PTx), a private, fully integrated biotechnology company, announced new data from a post hoc analysis of the eNRGy trial (NCT02912949), evaluating zenocutuzumab in patients with advanced neuregulin 1 fusion-positive (NRG1+) pancreatic adenocarcinoma (PDAC) and cholangiocarcinoma (CCA) who continued therapy beyond progression. Results were presented in a poster session at the 2026 ASCO Gastrointestinal Cancers Symposium in San Francisco, California.

“These findings highlight an important therapeutic opportunity for patients with NRG1 ...

• 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 ...

• IMREPLYS^® is the first treatment for H-ARS approved in Europe
• Approval based upon IMREPLYS^® significantly improving survival, accelerating recovery of white blood cells and platelets, and reducing rates of infection and sepsis after radiation exposure without the need for supportive care such as blood products.²

Lexington, MA – September 9, 2025 – Partner Therapeutics, Inc. (PTx) today announced that the European Commission has granted a marketing authorization in the European Union (EU) for IMREPLYS^® (sargramostim, rhu GM-CSF), the ...

Lexington, MA – June 20, 2025 – Partner Therapeutics, Inc. (PTx) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of PTx’s Marketing Authorisation Application (MAA) for IMREPLYS® (sargramostim, rhu GM-CSF), the same formulation that was approved by the U.S. Food and Drug Administration (FDA) under the brand name LEUKINE® in 2018. IMPREPLYS would be indicated for treatment of patients of all ages acutely exposed to myelosuppressive ...