Bora CDMO Bora CDMO

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[{"orgOrder":0,"company":"Puma Biotechnology","sponsor":"Bixink Therapeutics","pharmaFlowCategory":"D","amount":"$6.0 million","upfrontCash":"Undisclosed","newsHeadline":"Puma Biotechnology and Bixink Therapeutics Enter into Exclusive Licensing Agreement to Commercialize NERLYNX\u00ae (neratinib) in South Korea","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"April 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Puma Biotechnology","sponsor":"Acentrus Specialty","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Acentrus Specialty Partners with Puma Biotechnology to Bring Nerlynx\u00ae (neratinib) to Health Systems and Hospitals in the Acentrus Network","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"July 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Puma Biotechnology","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Puma Biotechnology Publishes Results from Phase II SUMMIT Trial Evaluating Neratinib in HER2-Mutant, Metastatic Cervical Cancers","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"July 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"Puma Biotechnology","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Puma Biotechnology Announces Publication of Interim Results of Phase II CONTROL Trial in Annals of Oncology","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"August 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Puma Biotechnology","sponsor":"Puma Biotechnology","pharmaFlowCategory":"D","amount":"$2.0 million","upfrontCash":"Undisclosed","newsHeadline":"NCCN Oncology Research Program and Puma Biotechnology, Inc. 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Applicable","upfrontCash":"Not Applicable","newsHeadline":"Puma Biotechnology Presents Updated Results from the Phase II SUMMIT Trial of Neratinib at SABCS 2020","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"December 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"Puma Biotechnology","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Puma Biotechnology Presents Efficacy and Safety Outcomes from the Phase III NALA Trial at the 2020 SABCS","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"December 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Puma Biotechnology","sponsor":"Not 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Meeting","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"Puma Biotechnology","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Puma Biotechnology Presents Outcomes from the Metastatic Breast Cancer Cohort of the SUMMIT Trial at the ASCO 2022 Annual Meeting","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"Puma Biotechnology","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Puma Biotechnology Presents Updated Findings from the Phase II SUMMIT Basket Trial of Neratinib for HER2-Mutant, Recurrent\/Metastatic Cervical Cancer at the ESMO Congress 2022","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"September 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"Puma Biotechnology","sponsor":"Takeda Pharmaceutical","pharmaFlowCategory":"D","amount":"$294.3 million","upfrontCash":"$7.0 million","newsHeadline":"Puma Biotechnology Announces Exclusive License Agreement with Takeda for the Development and Commercialization of Alisertib, an Investigational Aurora Kinase A Inhibitor","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"September 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I"},{"orgOrder":0,"company":"Puma Biotechnology","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Puma Biotechnology Presents Updated Findings from the Phase II SUMMIT Basket Trial of Neratinib in EGFR Exon 18-Mutant NSCLC at the 2022 EORTC\/NCI\/AACR Symposium","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"October 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"Puma Biotechnology","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Puma Biotechnology Presents Updated Findings from the TBCRC-022 Trial at the 2022 San Antonio Breast Cancer Symposium","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"December 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"Puma Biotechnology","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Puma Biotechnology\u2019s Nerlynx\u00ae Included in NCCN Clinical Practice Guidelines for the Treatment of Breast Cancer with a HER2 Mutation","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"February 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"Puma Biotechnology","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Puma Biotechnology Announces FDA Clearance of IND for Alisertib in Small Cell Lung Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"August 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I"},{"orgOrder":0,"company":"Puma Biotechnology","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Puma Biotechnology Receives FDA Orphan Drug Designation for Alisertib for the Treatment of Small Cell Lung Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"September 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"Puma Biotechnology","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Puma Biotechnology Announces Initiation of ALISCA-Lung1 Phase II Trial of Alisertib in Small Cell Lung Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"February 2024","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"Puma Biotechnology","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Puma Biotechnology Announces FDA Allowance to Proceed Under IND for Alisertib in HER2-Negative, Hormone Receptor-Positive Metastatic Breast Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"March 2024","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I"},{"orgOrder":0,"company":"Puma Biotechnology","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Puma Biotechnology Announces Phase II Clinical Trial Design for Alisertib in HER2-Negative, Hormone Receptor-Positive Metastatic Breast Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"December 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"}]

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            MLN8237 (alisertib) is a high affinity, selective, orally bioavailable inhibitors of Aurora A. It is being developed for the treatment of HER2-negative, HR-positive metastatic breast cancer.

            Lead Product(s): Alisertib,Anastrozole

            Therapeutic Area: Oncology Product Name: MLN8237

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 20, 2024

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            MLN8237 (alisertib) is a high affinity, selective, orally bioavailable inhibitors of Aurora A. It is being developed for the treatment of small cell lung cancer.

            Lead Product(s): Alisertib

            Therapeutic Area: Oncology Product Name: MLN8237

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 13, 2024

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            MLN8237 (alisertib) is a high affinity, selective, orally bioavailable inhibitors of Aurora A. It is being developed for the treatment of HER2-negative, HR-positive metastatic breast cancer.

            Lead Product(s): Alisertib,Anastrozole

            Therapeutic Area: Oncology Product Name: MLN8237

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable December 11, 2023

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            MLN8237 (alisertib), a selective, small molecule, orally administered inhibitor of aurora kinase A. Initially, Puma intends to focus the development of alisertib on the treatment of small cell lung cancer and breast cancer.

            Lead Product(s): Alisertib

            Therapeutic Area: Oncology Product Name: MLN8237

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 21, 2023

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            ALI-4201 (alisertib), a selective, small molecule, orally administered inhibitor of aurora kinase A. Initially, Puma intends to focus the development of alisertib on the treatment of small cell lung cancer and breast cancer.

            Lead Product(s): Alisertib

            Therapeutic Area: Oncology Product Name: MLN8237

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 08, 2023

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            Nerlynx (neratinib) is a kinase inhibitor that irreversibly binds to EGFR, HER2, and HER4. It reduces EGFR and HER2 autophosphorylation, downstream MAPK and AKT signaling pathways, and showed antitumor activity in EGFR and/or HER2 expressing carcinoma cell lines.

            Lead Product(s): Neratinib,Fulvestrant,Trastuzumab

            Therapeutic Area: Oncology Product Name: Nerlynx

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 01, 2023

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            As a small molecule that can cross the blood brain barrier, Nerlynx (neratinib) potentially offers patients with HER2-positive metastatic breast cancer that has metastasized to the CNS a novel HER2 targeted treatment option.

            Lead Product(s): Neratinib,Capecitabine,Trastuzumab

            Therapeutic Area: Oncology Product Name: Nerlynx

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable December 07, 2022

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            NERLYNX® (neratinib) tablets, for oral use, is a kinase inhibitor indicated as a single agent, for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer, to follow adjuvant trastuzumab-based therapy.

            Lead Product(s): Neratinib,Fulvestrant,Trastuzumab

            Therapeutic Area: Oncology Product Name: Nerlynx

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 27, 2022

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            Alisertib (MLN8237), is an adenosine triphosphate–competitive and reversible inhibitor of aurora kinase A and results in disruption of mitosis leading to apoptosis of rapidly proliferating tumor cells that are dependent on aurora kinase A.

            Lead Product(s): Alisertib

            Therapeutic Area: Oncology Product Name: MLN8237

            Highest Development Status: Phase I Product Type: Small molecule

            Recipient: Takeda Pharmaceutical

            Deal Size: $294.3 million Upfront Cash: $7.0 million

            Deal Type: Licensing Agreement September 20, 2022

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            NERLYNX® (neratinib) tablets, for oral use, is a kinase inhibitor indicated as a single agent, for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer, to follow adjuvant trastuzumab-based therapy.

            Lead Product(s): Neratinib,Trastuzumab

            Therapeutic Area: Oncology Product Name: Nerlynx

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 11, 2022

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