Zenocutuzumab Treatment Beyond Progression Demonstrates Continued Benefit in Patients with NRG1+ Non-Small Cell Lung Cancer: New Results from the eNRGy Trial

 

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 ...

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Zenocutuzumab‑zbco Receives FDA Orphan Drug Designation for Treatment of Cholangiocarcinoma

 

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 ...

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Continued Zenocutuzumab Treatment Beyond Progression Shows Benefit in Patients with NRG1+ Pancreatic Cancer and Cholangiocarcinoma: New Results from the eNRGy Trial Presented at ASCO GI

 

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 ...

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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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Partner Therapeutics Receives EMA Approval of IMREPLYS® (sargramostim, rhu GM-CSF) to Treat Exposure to Myelosuppressive Doses of Radiation (Hematopoietic Sub-syndrome of Acute Radiation Syndrome [H-ARS])

  • 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 ...

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European Medicines Agency CHMP Recommends EU Approval of Partner Therapeutics IMREPLYS® (sargramostim, rhu GM-CSF) to Treat Exposure to Myelosuppressive Doses of Radiation (Haematopoietic Sub-syndrome of Acute Radiation Syndrome)

 

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 ...

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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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Merus Announces FDA Approval of BIZENGRI® (zenocutuzumab-zbco) for NRG1+ Pancreatic Adenocarcinoma and NRG1+ Non–Small Cell Lung Cancer (NSCLC) Based on Safety and Efficacy Data From the eNRGy Study

  • BIZENGRI® is the first and only therapy approved by the FDA specifically for pancreatic adenocarcinoma and NSCLC that harbor NRG1 gene fusions and are advanced unresectable or metastatic1
  • Merus and Partner Therapeutics announced a license agreement for U.S. commercialization

Utrecht, The Netherlands, and Cambridge, Massachusetts Dec. 04, 2024 /Globe Newswire/ — Merus N.V. (Nasdaq: MRUS) [Merus, the Company, we, or our], a clinical-stage oncology company developing innovative, full-length, multispecific antibodies (Biclonics® and Triclonics®), announced today that the U.S. Food and ...

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