[{"orgOrder":0,"company":"Orion Corporation","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Positive CHMP opinion for darolutamide as a new treatment for men with non-metastatic castration-resistant prostate cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"FINLAND","productType":"Small molecule","productStatus":"Approved","date":"January 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Orion Corporation","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"ARAMIS Phase III Data to be Presented at ASCO 2020 Reveals Nubeqa Linked with Improved Overall Survival in Non-Metastatic Prostate Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"FINLAND","productType":"Small molecule","productStatus":"Approved","date":"May 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of Ganaxolone","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"FINLAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"August 2021","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase III"},{"orgOrder":0,"company":"Orion Corporation","sponsor":"Alligator Bioscience","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Alligator Bioscience Announces Immuno-Oncology Research Collaboration and License Agreement with Orion Corporation","therapeuticArea":"Oncology","highestDevelopmentStatus":"Discovery","country":"FINLAND","productType":"Large molecule","productStatus":"Undisclosed","date":"August 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Discovery"},{"orgOrder":0,"company":"Orion Corporation","sponsor":"Bayer AG","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"ARASENS Trial with Darolutamide in Combination 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Patients with Pulmonary Hypertension and Heart Failure with Preserved Ejection Fraction (PH-HFpEF)","therapeuticArea":"Cardiology\/Vascular Diseases","highestDevelopmentStatus":"Phase II","country":"FINLAND","productType":"Small molecule","productStatus":"Approved","date":"October 2022","url1":"","url2":"","graph1":"Cardiology\/Vascular Diseases","graph2":"Phase II"},{"orgOrder":0,"company":"Orion Corporation","sponsor":"Amneal Pharmaceuticals","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Amneal Announces Strategic European Partnership with Orion Corporation","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"FINLAND","productType":"Small molecule","productStatus":"Approved","date":"January 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"}]
Find Clinical Drug Pipeline Developments & Deals by Fermion Oy
Abiraterone acetate is a medication used to treat prostate cancer. Specifically it is used together with a corticosteroid for metastatic castration-resistant prostate cancer and metastatic high-risk castration-sensitive prostate cancer.
Levosimendan (TNX-102 and TNX-103) is a unique potassium ATP channel activator and calcium sensitizer that affects the heart and vascular system through multiple mechanisms of action.
ODM-208 is an oral, non-steroidal inhibitor of CYP11A1 currently being evaluated in a Phase 2 clinical trial for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC).
The sNDA is based on positive results from pivotal Phase III ARASENS trial demonstrating a statistically significant improvement in overall survival for Nubeqa (darolutamide) plus androgen deprivation therapy and docetaxel in men with mHSPC compared to ADT plus docetaxel.
Submission based on data ARASENS trial, showing that use of darolutamide plus androgen deprivation therapy and docetaxel led to a statistically significant improvement in overall survival compared to ADT plus docetaxel.
The submissions are supported by positive results from the Phase III ARASENS trial, showing a statistically significant improvement in overall survival (OS) for darolutamide plus ADT and docetaxel in men with mHSPC.
Lead Product(s):Darolutamide,Androgen Deprivation Therapy
ODM-208 is a novel, oral, non-steroidal and selective inhibitor of CYP11A1 enzyme developed by Orion for the treatment of prostate cancer. ODM-208 suppresses the production of all steroid hormones and their precursors that may activate AR signalling pathway.
Darolutamide is an oral androgen receptor inhibitor (ARi) with a distinct chemical structure that binds to the receptor with high affinity and exhibits strong antagonistic activity, thereby inhibiting the receptor function and the growth of prostate cancer cells.
The research collaboration is based on new innovations to improve the structure of the CAR T-cell product. In CAR T-cell therapy, the patient's own white blood cells are genetically modified to attack the cancer and kill it.
The ARASENS trial, Nubeqa (darolutamide) in combination with docetaxel and androgen deprivation therapy significantly increased overall survival for patients with metastatic hormone-sensitive prostate cancer.
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