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Details:
Nubeqa (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.
Lead Product(s): Darolutamide,Docetaxel
Therapeutic Area: Oncology Product Name: Nubeqa
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Bayer AG
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 23, 2023
Iran Expo
Not Confirmed
Contact SupplierDetails:
Nubeqa (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.
Lead Product(s): Darolutamide,Docetaxel
Therapeutic Area: Oncology Product Name: Nubeqa
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 20, 2023
Iran Expo
Not Confirmed
Contact SupplierDetails:
Nubeqa (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.
Lead Product(s): Darolutamide,Docetaxel
Therapeutic Area: Oncology Product Name: Nubeqa
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 01, 2023
Iran Expo
Not Confirmed
Contact SupplierDetails:
Nubeqa (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.
Lead Product(s): Darolutamide,Docetaxel
Therapeutic Area: Oncology Product Name: Nubeqa
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Bayer AG
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 27, 2023
Iran Expo
Not Confirmed
Contact SupplierDetails:
Nubeqa (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.
Lead Product(s): Darolutamide,Docetaxel
Therapeutic Area: Oncology Product Name: Nubeqa
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 27, 2023
Iran Expo
Not Confirmed
Contact SupplierDetails:
Nubeqa (darolutamide) is an oral androgen receptor inhibitor with a unique chemical structure developed to inhibit the growth of cancer cells. FDA has approved its use in combination with docetaxel for treating metastatic hormone-sensitive prostate cancer.
Lead Product(s): Darolutamide,Docetaxel
Therapeutic Area: Oncology Product Name: Nubeqa
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 08, 2022
Iran Expo
Not Confirmed
Contact SupplierDetails:
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.
Lead Product(s): Darolutamide,Docetaxel
Therapeutic Area: Oncology Product Name: Nubeqa
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Bayer AG
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 03, 2022
Iran Expo
Not Confirmed
Contact SupplierDetails:
Nubeqa (darolutamide) is an oral androgen receptor inhibitor with a unique chemical structure developed to inhibit the growth of cancer cells. FDA has approved its use in combination with docetaxel for treating metastatic hormone-sensitive prostate cancer.
Lead Product(s): Darolutamide,Docetaxel
Therapeutic Area: Oncology Product Name: Nubeqa
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 24, 2022
Iran Expo
Not Confirmed
Contact SupplierDetails:
Nubeqa (darolutamide) is an oral androgen receptor inhibitor with a unique chemical structure developed to inhibit the growth of cancer cells. FDA has approved its use in combination with docetaxel for treating metastatic hormone-sensitive prostate cancer.
Lead Product(s): Darolutamide
Therapeutic Area: Oncology Product Name: Nubeqa
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Bayer AG
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 08, 2022
Iran Expo
Not Confirmed
Contact SupplierDetails:
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.
Lead Product(s): Darolutamide,Docetaxel
Therapeutic Area: Oncology Product Name: Nubeqa
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Bayer AG
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 03, 2021
Iran Expo
Not Confirmed
Contact SupplierDetails:
Darolutamide significantly reduced risk of death by 31 percent in men with non-metastatic castration-resistant prostate cancer (nmCRPC).
Lead Product(s): Darolutamide
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 14, 2020
Iran Expo
Not Confirmed
Contact SupplierDetails:
The CHMP recommendation is based on the results of the Phase III ARAMIS trial evaluating darolutamide plus androgen deprivation therapy (ADT) compared to placebo plus ADT.
Lead Product(s): Darolutamide
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 31, 2020
Iran Expo
Not Confirmed
Contact Supplier
Details:
The collaboration aims to develop next-generation sequencing-based companion diagnostic assays to identify patients who may benefit from Bayer’s portfolio of precision cancer therapies, including Nubeqa (darolutamide), a medication for certain prostate cancers (mHSPC, nmCRPC).
Lead Product(s): Darolutamide
Therapeutic Area: Oncology Product Name: Nubeqa
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Bayer AG
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration March 20, 2024
Details:
PKI-587 (gedatolisib) is an investigational, intravenously administered pan-class I isoform PI3K and mTOR inhibitor. It is being evaluated in combination with Nubeqa (darolutamide) for the treatment of metastatic castration resistant prostate cancer.
Lead Product(s): Gedatolisib,Darolutamide
Therapeutic Area: Oncology Product Name: PKI-587
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 22, 2024
Details:
Under the agreement, Bayer will provide Nubeqa to Celcuity for its Phase 1b/2 trial of PKI-587 (gedatolisib), a potent inhibitor that selectively targets all Class I isoforms of PI3K and mTOR, in combination with darolutamide in metastatic castration resistant prostate cancer.
Lead Product(s): Gedatolisib,Darolutamide
Therapeutic Area: Oncology Product Name: PF-05212384
Highest Development Status: IND EnablingProduct Type: Small molecule
Partner/Sponsor/Collaborator: Bayer AG
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration August 22, 2023
Details:
PKI-587 (gedatolisib) is a potent inhibitor that selectively targets all Class I isoforms of PI3K and mTOR, and investigating in ombination with darolutamide for the treatment of patients with metastatic castration resistant prostate cancer.
Lead Product(s): Gedatolisib,Darolutamide
Therapeutic Area: Oncology Product Name: PF-05212384
Highest Development Status: IND EnablingProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 22, 2023
Details:
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 IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Telix Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement May 08, 2023
Details:
Nubeqa (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.
Lead Product(s): Darolutamide,Docetaxel
Therapeutic Area: Oncology Product Name: Nubeqa
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 01, 2023
Details:
Nubeqa™ (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.
Lead Product(s): Darolutamide,Docetaxel
Therapeutic Area: Oncology Product Name: Nubeqa
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 27, 2023
Details:
Darolutamide (nubeqa) 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.
Lead Product(s): Darolutamide,Docetaxel
Therapeutic Area: Oncology Product Name: Nubeqa
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 05, 2022
Details:
Nubeqa (darolutamide), is an oral androgen receptor inhibitor with distinct chemical structure that binds to receptor with high affinity and exhibits strong antagonistic activity, thereby inhibiting receptor function and the growth of prostate cancer cells.
Lead Product(s): Darolutamide,Docetaxel
Therapeutic Area: Oncology Product Name: Nubeqa
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 11, 2022
Details:
NUBEQA (darolutamide) is also being investigated in further studies across various stages of prostate cancer, including in the ARANOTE Phase III trial evaluating NUBEQA plus androgen deprivation therapy (ADT) versus ADT alone for mHSPC.
Lead Product(s): Darolutamide
Therapeutic Area: Oncology Product Name: Nubeqa
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 30, 2022
Details:
Approval is based on results trial that demonstrated statistically significant increase in overall survival (OS), trial’s primary endpoint, with reduction in risk of death by 32% for those treated with NUBEQA (darolutamide) plus ADT and docetaxel compared to ADT and docetaxel.
Lead Product(s): Darolutamide,Docetaxel
Therapeutic Area: Oncology Product Name: Nubeqa
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 08, 2022
Details:
The ARASENS trial demonstrated that Nubeqa (darolutamide) plus androgen deprivation therapy (ADT) and docetaxel significantly reduced the risk of death by 32.5% compared to ADT plus docetaxel.
Lead Product(s): Darolutamide,Docetaxel
Therapeutic Area: Oncology Product Name: Nubeqa
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 08, 2022
Details:
Data from Phase III ARASENS trial in patients with mHSPC, showed that Nubeqa (darolutamide) plus ADT and docetaxel provides consistently favorable OS benefits across patient subgroups with various types of metastatic disease, compared to placebo plus ADT and docetaxel.
Lead Product(s): Darolutamide,Androgen Deprivation Therapy,Docetaxel
Therapeutic Area: Oncology Product Name: Nubeqa
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 04, 2022
Details:
Nubeqa (darolutamide) is an androgen receptor inhibitor (ARi) with a distinct chemical structure that competitively inhibits androgen binding, AR nuclear translocation, and AR-mediated transcription.
Lead Product(s): Darolutamide
Therapeutic Area: Oncology Product Name: Nubeqa
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 19, 2022
Details:
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.
Lead Product(s): Darolutamide,Docetaxel
Therapeutic Area: Oncology Product Name: Nubeqa
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Orion Corporation
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 22, 2022
Details:
The CDE submission is supported by positive results from Phase III ARASENS trial, showing a statistically significant improvement in overall survival for darolutamide plus androgen deprivation therapy and docetaxel in men with mHSPC.
Lead Product(s): Darolutamide
Therapeutic Area: Oncology Product Name: Nubeqa
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 22, 2022
Details:
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
Therapeutic Area: Oncology Product Name: Nubeqa
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Orion Corporation
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 09, 2022
Details:
The submissions are supported by positive results from the Phase III ARASENS trial, showing a statistically significant improvement in overall survival (OS) for Nubeqa (darolutamide) plus androgen deprivation therapy (ADT) and docetaxel in men with mHSPC.
Lead Product(s): Darolutamide,Docetaxel
Therapeutic Area: Oncology Product Name: Nubeqa
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 09, 2022
Details:
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.
Lead Product(s): Darolutamide,Docetaxel
Therapeutic Area: Oncology Product Name: Nubeqa
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Orion Corporation
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 17, 2022
Details:
Darolutamide plus ADT and docetaxel also showed consistent benefits for secondary endpoints and pre-specified subgroups. Adverse event (AE) rates were not increased by the addition of darolutamide.
Lead Product(s): Darolutamide,Docetaxel
Therapeutic Area: Oncology Product Name: Nubeqa
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 17, 2022
Details:
The Phase III ARASENS trial investigating the use of the oral androgen receptor inhibitor (ARi) Nubeqa™ (darolutamide) in metastatic hormone-sensitive prostate cancer (mHSPC) has met its primary endpoint.
Lead Product(s): Darolutamide,Docetaxel
Therapeutic Area: Oncology Product Name: Nubeqa
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 03, 2021
Details:
The Phase III trial showed that Nubeqa (darolutamide) in combination with chemotherapeutic agent docetaxel and ADT increases overall survival,an established treatment for advanced hormone-sensitive prostate cancer.
Lead Product(s): Darolutamide,Docetaxel
Therapeutic Area: Oncology Product Name: Nubeqa
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 03, 2021
Details:
EPI-7386 is currently being studied in a Phase 1 clinical trial in men with metastatic castration-resistant prostate cancer ("mCRPC") whose tumors have progressed on current standard-of-care therapies.
Lead Product(s): Masofaniten,Darolutamide
Therapeutic Area: Oncology Product Name: EPI-7386
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 07, 2021
Details:
Post-hoc analysis of the Phase III ARAMIS trial showed NUBEQA® (darolutamide) was associated with delayed deterioration in patient quality of life (QoL) related to urinary and bowel symptoms in men with non-metastatic castration-resistant prostate cancer (nmCRPC).
Lead Product(s): Darolutamide
Therapeutic Area: Oncology Product Name: Nubeqa
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 14, 2021
Details:
Bayer may sponsor and conduct a Phase 1/2 study to evaluate the safety, pharmacokinetics and efficacy of the combination of EPI-7386 and darolutamide in mCRPC patients. ESSA will supply EPI-7386 for the trial and will retain all rights to EPI-7386.
Lead Product(s): Masofaniten,Darolutamide
Therapeutic Area: Oncology Product Name: EPI-7386
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Bayer AG
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration April 28, 2021
Details:
Nubeqa (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.
Lead Product(s): Darolutamide,Androgen Deprivation Therapy
Therapeutic Area: Oncology Product Name: Nubeqa
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Bayer AG
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 08, 2021
Details:
NUBEQA significantly reduced the risk of death by 31%, offering men with non-metastatic castration-resistant prostate cancer (nmCRPC) extended survival for a greater chance of living longer.
Lead Product(s): Darolutamide
Therapeutic Area: Oncology Product Name: Nubeqa
Highest Development Status: Phase IVProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 08, 2021
Details:
Men with non-metastatic castration-resistant prostate cancer (nmCRPC) receiving darolutamide plus androgen deprivation therapy (ADT) had a significant improvement in overall survival (OS) compared to placebo plus ADT.
Lead Product(s): Darolutamide
Therapeutic Area: Oncology Product Name: Nubeqa
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Orion Corporation
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 09, 2020
Details:
The study was double-blind until metastases or unacceptable toxicity occurred. After unblinding, the patients could choose to continue their darolutamide plus ADT treatment or receive darolutamide instead of placebo.
Lead Product(s): Darolutamide
Therapeutic Area: Oncology Product Name: Nubeqa
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 03, 2020
Details:
The transaction follows the Sales of Nubeqa® (darolutamide), jointly developed by Orion Corporation and Bayer for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC), started in the EU and Japan.
Lead Product(s): Darolutamide
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Bayer AG
Deal Size: $31.3 million Upfront Cash: Undisclosed
Deal Type: Agreement May 20, 2020
Details:
The approval is based on Phase III ARAMIS trial results showing a statistically significant improvement in metastasis-free survival (MFS) for darolutamide plus androgen deprivation therapy (ADT) versus placebo plus ADT, and a favorable safety profile.
Lead Product(s): Darolutamide
Therapeutic Area: Oncology Product Name: Nubeqa
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 30, 2020
Details:
Results from Phase III ARAMIS trial that investigated Nubeqa (darolutamide) in men with nMCRC, show a statistically significant improvement in overall survival in patients receiving darolutamide plus androgen deprivation therapy compared to placebo plus ADT.
Lead Product(s): Darolutamide
Therapeutic Area: Oncology Product Name: Nubeqa
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 30, 2020
Details:
Approval is based on Phase III ARAMIS trial showing a highly significant improvement in primary efficacy endpoint of metastasis-free survival, with a median 40.4 months for Nubeqa (darolutamide) plus ADT versus 18.4 months for placebo plus ADT.
Lead Product(s): Darolutamide
Therapeutic Area: Oncology Product Name: Nubeqa
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 23, 2020
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