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NEWS #PharmaBuzz
09 Jan 2026
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/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-302656811.html
07 Dec 2025
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/zenocutuzumab-zbco-bizengri-shows-durable-efficacy-in-patients-with-treatment-naive-nrg1nsclc-updated-enrgy-trial-results-presented-at-iaslc-asco-naclc-302634170.html
24 Oct 2025
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/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-302593179.html
21 Aug 2025
// EMA
https://www.ema.europa.eu/en/documents/overview/imreplys-epar-medicine-overview_en.pdf
05 Feb 2025
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/new-england-journal-of-medicine-publishes-results-of-global-multicenter-enrgy-study-evaluating-zenocutuzumab-zbco-bizengri-in-nrg1-cancer-302369431.html
09 Jan 2025
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/barda-and-partner-therapeutics-continue-partnership-around-development-of-leukine-sargramostim-rhu-gm-csf-to-potentially-improve-patient-care-for-sepsis-302347356.html
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32798
Submission : 2018-04-27
Status : Active
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32798
Submission : 2018-04-27
Status : Active
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
Details:
Zenocutuzumab, an unconjugated antibody targeting HER2 and HER3, shows promise in treating cholangiocarcinoma Key Focus Area.
Lead Product(s): Zenocutuzumab
Therapeutic Area: Oncology Brand Name: Bizengri
Study Phase: Approved FDFProduct Type: Antibody, Unconjugated
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 24, 2025
Lead Product(s) : Zenocutuzumab
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Zenocutuzumab Gets FDA Breakthrough for NRG1+ Cholangiocarcinoma
Details : Zenocutuzumab, an unconjugated antibody targeting HER2 and HER3, shows promise in treating cholangiocarcinoma Key Focus Area.
Product Name : Bizengri
Product Type : Antibody, Unconjugated
Upfront Cash : Inapplicable
October 24, 2025
Details:
The collaboration aims to fund a phase 2 in sepsis to assess the safety and enable dose selection of LEUKINE (sargramostim), a glycosylated recombinant human granulocyte-macrophage CSF.
Lead Product(s): Sargramostim
Therapeutic Area: Infections and Infectious Diseases Brand Name: Leukine
Study Phase: Phase IIProduct Type: Protein
Sponsor: BARDA
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration January 09, 2025
Lead Product(s) : Sargramostim
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : BARDA
Deal Size : Undisclosed
Deal Type : Collaboration
BARDA, Partner Therapeutics Develop LEUKINE® for Sepsis Care Improvement
Details : The collaboration aims to fund a phase 2 in sepsis to assess the safety and enable dose selection of LEUKINE (sargramostim), a glycosylated recombinant human granulocyte-macrophage CSF.
Product Name : Leukine
Product Type : Protein
Upfront Cash : Undisclosed
January 09, 2025
Details:
Under the terms of the license agreement, PTx will assume full rights to U.S. commercialization of Bizengri (Zenocutuzumab) for the treatment of NRG1+ cancer.
Lead Product(s): Zenocutuzumab
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Approved FDFProduct Type: Antibody, Unconjugated
Recipient: Merus
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement December 02, 2024
Lead Product(s) : Zenocutuzumab
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Recipient : Merus
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Merus & Partner Therapeutics License Zenocutuzumab for NRG1 Fusion Cancer US
Details : Under the terms of the license agreement, PTx will assume full rights to U.S. commercialization of Bizengri (Zenocutuzumab) for the treatment of NRG1+ cancer.
Product Name : Undisclosed
Product Type : Antibody, Unconjugated
Upfront Cash : Undisclosed
December 02, 2024
Details:
Sargmalin (sargramostim) is a glycosylated recombinant human granulocyte-macrophage colony-stimulating factor (rhu GM-CSF). It is approved for autoimmune pulmonary alveolar proteinosis.
Lead Product(s): Sargramostim
Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Sargmalin
Study Phase: Approved FDFProduct Type: Protein
Recipient: Nobelpharma
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 03, 2024
Lead Product(s) : Sargramostim
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Approved FDF
Recipient : Nobelpharma
Deal Size : Inapplicable
Deal Type : Inapplicable
Partner Therapeutics' Leukine® (sargramostim) Approved in Japan for aPAP
Details : Sargmalin (sargramostim) is a glycosylated recombinant human granulocyte-macrophage colony-stimulating factor (rhu GM-CSF). It is approved for autoimmune pulmonary alveolar proteinosis.
Product Name : Sargmalin
Product Type : Protein
Upfront Cash : Inapplicable
April 03, 2024
Details:
Sargramostim is a Protein drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Parkinson Disease.
Lead Product(s): Sargramostim
Therapeutic Area: Neurology Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Protein
Recipient: University of Nebraska
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 10, 2023
Biomarker Validation Following Sargramostim Treatment in Parkinson's Disease
Details : Sargramostim is a Protein drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Parkinson Disease.
Product Name : Undisclosed
Product Type : Protein
Upfront Cash : Inapplicable
January 10, 2023
Details:
Leukine (sargramostim) is a glycosylated recombinant human granulocyte-macrophage colony-stimulating factor (rhu GM-CSF) produced by recombinant DNA technology in yeast.
Lead Product(s): Sargramostim
Therapeutic Area: Oncology Brand Name: Leukine
Study Phase: Phase IIIProduct Type: Protein
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 15, 2022
Partner Therapeutics Announces Publication of a Retrospective Cohort Review of 15 LEUKINE® Treate...
Details : Leukine (sargramostim) is a glycosylated recombinant human granulocyte-macrophage colony-stimulating factor (rhu GM-CSF) produced by recombinant DNA technology in yeast.
Product Name : Leukine
Product Type : Protein
Upfront Cash : Inapplicable
December 15, 2022
Details:
Sargramostim is a Protein drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Physiological Effects of Drugs.
Lead Product(s): Sargramostim
Therapeutic Area: Pharmacology/Toxicology Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Protein
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 09, 2022
Lead Product(s) : Sargramostim
Therapeutic Area : Pharmacology/Toxicology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Sargramostim is a Protein drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Physiological Effects of Drugs.
Product Name : Undisclosed
Product Type : Protein
Upfront Cash : Inapplicable
May 09, 2022
Details:
People with Down syndrome are at higher risk for Alzheimer’s, and showed that GM-CSF improves cognition and brain pathology in AD mice and that Leukine® (sargramostim, glycosylated, yeast-derived rhuGM-CSF) improved cognition and reduced blood biomarkers of neuronal damage.
Lead Product(s): Sargramostim
Therapeutic Area: Genetic Disease Brand Name: Leukine
Study Phase: PreclinicalProduct Type: Protein
Sponsor: University of Colorado
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 29, 2022
Lead Product(s) : Sargramostim
Therapeutic Area : Genetic Disease
Highest Development Status : Preclinical
Partner/Sponsor/Collaborator : University of Colorado
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : People with Down syndrome are at higher risk for Alzheimer’s, and showed that GM-CSF improves cognition and brain pathology in AD mice and that Leukine® (sargramostim, glycosylated, yeast-derived rhuGM-CSF) improved cognition and reduced blood biomark...
Product Name : Leukine
Product Type : Protein
Upfront Cash : Inapplicable
March 29, 2022
Details:
Sargramostim is a Protein drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Neoplasms.
Lead Product(s): Sargramostim,Ipilimumab
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Protein
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 17, 2022
Lead Product(s) : Sargramostim,Ipilimumab
Therapeutic Area : Oncology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Sargramostim With Ipilimumab Containing Therapy in Patients With Solid Tumors
Details : Sargramostim is a Protein drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Neoplasms.
Product Name : Undisclosed
Product Type : Protein
Upfront Cash : Inapplicable
March 17, 2022
Details:
Safety and efficacy of inhaled sargramostim for the treatment of COVID-19 has not been established and sargramostim is not approved for treatment of COVID-19. Sargramostim has a different mechanism of action from recombinant G-CSFs products and data should not be extrapolated.
Lead Product(s): Sargramostim
Therapeutic Area: Infections and Infectious Diseases Brand Name: Leukine
Study Phase: Phase IVProduct Type: Protein
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 28, 2021
Lead Product(s) : Sargramostim
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Second Randomized Trial of Leukine® (sargramostim) in COVID-19 Demonstrates Improvement in Lung F...
Details : Safety and efficacy of inhaled sargramostim for the treatment of COVID-19 has not been established and sargramostim is not approved for treatment of COVID-19. Sargramostim has a different mechanism of action from recombinant G-CSFs products and data shou...
Product Name : Leukine
Product Type : Protein
Upfront Cash : Inapplicable
June 28, 2021
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