LGM Pharma API Sourcing. CDMO Services, Regulatory Expertise. LGM Pharma API Sourcing. CDMO Services, Regulatory Expertise.

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2023","url1":"","url2":"","graph1":"Oncology","graph2":"Discovery"},{"orgOrder":0,"company":"Leaps by Bayer","sponsor":"Boundless Bio","pharmaFlowCategory":"D","amount":"$100.0 million","upfrontCash":"Undisclosed","newsHeadline":"Boundless Bio Announces $100 Million Series C Financing co-led by Leaps by Bayer and RA Capital Management to Advance First ecDNA-Directed Therapies for Patients with Oncogene Amplified Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"GERMANY","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I"},{"orgOrder":0,"company":"Bayer AG","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Bayer Receives U.S. FDA Fast Track Designation for Asundexian Atrial Fibrillation Program","therapeuticArea":"Cardiology\/Vascular Diseases","highestDevelopmentStatus":"Phase III","country":"GERMANY","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2023","url1":"","url2":"","graph1":"Cardiology\/Vascular Diseases","graph2":"Phase III"},{"orgOrder":0,"company":"Leaps by Bayer","sponsor":"Indapta Therapeutics","pharmaFlowCategory":"D","amount":"$60.0 million","upfrontCash":"Undisclosed","newsHeadline":"Indapta Therapeutics Announces U.S. FDA Clearance of IND for IDP-023, an Allogeneic Natural Killer (NK) Cell Therapy for Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"IND Enabling","country":"GERMANY","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"May 2023","url1":"","url2":"","graph1":"Oncology","graph2":"IND Enabling"},{"orgOrder":0,"company":"Bayer AG","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Kerendia\u2122 (finerenone) Granted Expanded Indication in China for Broad Range of Patients with Chronic Kidney Disease and Type 2 Diabetes","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Approved","country":"GERMANY","productType":"Small molecule","productStatus":"Approved","date":"May 2023","url1":"","url2":"","graph1":"Nephrology","graph2":"Approved"},{"orgOrder":0,"company":"Bayer AG","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Bayer initiates phase III study to investigate aflibercept 8 mg in retinal vein occlusion","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Approved","country":"GERMANY","productType":"Large molecule","productStatus":"Approved","date":"May 2023","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Approved"},{"orgOrder":0,"company":"Bayer AG","sponsor":"Cedilla Therapeutics","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Bayer to Acquire Exclusive License from Cedilla Therapeutics on Selective Inhibitors in Pre-Clinical Precision Oncology","therapeuticArea":"Oncology","highestDevelopmentStatus":"Preclinical","country":"GERMANY","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Preclinical"},{"orgOrder":0,"company":"Bayer AG","sponsor":"Merck & Co","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Bayer Starts Phase II\/III Study with Vericiguat in Children with Heart Failure","therapeuticArea":"Cardiology\/Vascular Diseases","highestDevelopmentStatus":"Approved","country":"GERMANY","productType":"Small molecule","productStatus":"Approved","date":"June 2023","url1":"","url2":"","graph1":"Cardiology\/Vascular Diseases","graph2":"Approved"}]

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            Details:

            The collaboration strengthens Bayer’s early pipeline in precision oncology by gaining rights to develop and commercialize Cedilla’s CyclinE1/CDK2 complex inhibitors which selectively address oncogenic drivers.

            Lead Product(s): Undisclosed

            Therapeutic Area: Oncology Product Name: Undisclosed

            Highest Development Status: Preclinical Product Type: Small molecule

            Recipient: Cedilla Therapeutics

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Licensing Agreement June 01, 2023

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            Verquvo (vericiguat) is an oral once daily stimulator of soluble guanylate cyclase (sGC), an important enzyme in the NO-sGC-cGMP signaling pathway and currently in pediatric patients aged > 28 days to 18 years with heart failure.

            Lead Product(s): Vericiguat

            Therapeutic Area: Cardiology/Vascular Diseases Product Name: Verquvo

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Merck & Co

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 01, 2023

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            The financing will be used for the first-in-human phase 1 trial of DP-023, an Allogeneic Natural Killer (NK) Cell Therapy in patients with multiple myeloma and lymphoma.

            Lead Product(s): IDP-023,Antibody

            Therapeutic Area: Oncology Product Name: IDP-023

            Highest Development Status: IND Enabling Product Type: Cell and Gene therapy

            Recipient: Indapta Therapeutics

            Deal Size: $60.0 million Upfront Cash: Undisclosed

            Deal Type: Series A Financing May 17, 2023

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            Kerendia (finerenone) is a non-steroidal, selective mineralocorticoid receptor antagonist that has been shown to block harmful effects of MR overactivation. It has been granted marketing authorization for expanded indication in China for chronic kidney disease and T2D.

            Lead Product(s): Finerenone

            Therapeutic Area: Nephrology Product Name: Kerendia

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 17, 2023

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            Boundless Bio will use the financing to advance BBI-355, a potentially best-in-class checkpoint kinase 1 inhibitor and the first ecDNA-directed therapy, through meaningful clinical readouts from its ongoing Phase 1/2 clinical trial in patients with oncogene-amplified cancers.

            Lead Product(s): ecDNA-directed Therapy

            Therapeutic Area: Oncology Product Name: BBI-355

            Highest Development Status: Phase I Product Type: Small molecule

            Recipient: Boundless Bio

            Deal Size: $100.0 million Upfront Cash: Undisclosed

            Deal Type: Series C Financing May 16, 2023

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            BAY2433334 (asundexian) is as an oral direct, potent inhibitor of activated coagulation factor XI (FXIa), acts selectively on the coagulation cascade, thereby offering the potential to prevent events like stroke without a corresponding increase in bleeding risk.

            Lead Product(s): Asundexian

            Therapeutic Area: Cardiology/Vascular Diseases Product Name: BAY2433334

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 16, 2023

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            The collaboration will leverage Bicycle Therapeutic’s proprietary bicyclic peptides technology (Bicycle®), for the discovery and development, manufacture, and commercialize Bicycle radioconjugates for multiple agreed upon oncology targets.

            Lead Product(s): Bicyclic Peptide-based Radio Conjugate

            Therapeutic Area: Oncology Product Name: Undislcosed

            Highest Development Status: Discovery Product Type: Peptide

            Recipient: Bicycle Therapeutics

            Deal Size: $1,745.0 million Upfront Cash: $45.0 million

            Deal Type: Collaboration May 10, 2023

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            Eylea (aflibercept) is a vascular endothelial growth factor (VEGF) inhibitor used to treat Neovascular (Wet) Age-Related Macular Degeneration (AMD), various types of macular edema and diabetic retinopathy.

            Lead Product(s): Aflibercept

            Therapeutic Area: Ophthalmology Product Name: Eylea

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 10, 2023

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            Under the agreement, Telix will suppy Illuccix (TLX591-CDx, kit for the preparation of gallium Ga 68 gozetotide injection) for the Phase III ARASTEP study, investigating Bayer's ARi Nubeqa (darolutamide) plus ADT versus ADT alone in hormone-sensitive prostate cancer.

            Lead Product(s): Darolutamide,Androgen Deprivation Therapy

            Therapeutic Area: Oncology Product Name: Nubeqa

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Telix Pharmaceuticals

            Deal Size: Undisclosed Upfront Cash: Undisclosed