• 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 ...

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 ...

• 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 ...

UTRECHT, The Netherlands and CAMBRIDGE, Mass., December 2, 2024– 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^®) and Partner Therapeutics, Inc. (PTx), a private, fully-integrated biotechnology company with a focus in hematology and oncology, today announced they have entered into an agreement in which Merus has exclusively licensed to PTx the right to commercialize zenocutuzumab (Zeno) for the treatment of NRG1 fusion-positive (NRG1+) cancer ...

NCI sponsored, ECOG-ACRIN Phase 3 Study of Leukine in Combination with Ipilimumab and Nivolumab in Front Line Treatment of Melanoma Heads to Last Stages of Enrollment

Lexington, MA – April 18, 2024 — Partner Therapeutics, Inc. (PTx) announced publication of a comprehensive review by Dougan et al.¹ in Cancers summarizing the mechanistic rationale and pre-clinical and clinical data regarding the use of Leukine (sargramostim; glycosylated, yeast-derived recombinant human granulocyte-macrophage colony-stimulating factor [rhu GM-CSF]) to manage gastrointestinal ...

Treatment will be Marketed by Nobelpharma Co. Ltd. Under the Trade Name Sargmalin^®

PMDA Approval of Sargmalin is the first regulatory approval of an inhaled recombinant GM-CSF product for aPAP

Lexington, MA – April 3, 2024 — Partner Therapeutics, Inc. (PTx) announced that its partner Nobelpharma received approval from the Japanese Pharmaceuticals and Medical Device Agency (PMDA) for the inhaled use of Leukine (sargramostim), branded in Japan as Sargmalin, to treat aPAP. PTx licensed rights for certain indications ...

Lexington, MA – January 17, 2024 – Partner Therapeutics, Inc. (PTx) announced today the publication of a comprehensive review by Mora et al. in the International Journal of Cancer which summarizes the efficacy and safety of anti-GD2 monoclonal antibodies (mAbs) (dinutuximab, dinutuximab beta, and naxitamab) in children with high-risk neuroblastoma when given in combination with Leukine (sargramostim; glycosylated, yeast-derived recombinant human granulocyte-macrophage colony-stimulating factor [rhu GM-CSF]), recombinant human granulocyte colony-stimulating factor (G-CSF) or no cytokine.¹

The review provides ...