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Details:

Ostarine (enobosarm) is a selective androgen receptor modulator, small molecule drug candidate. It is currently being evaluated in combination with semaglutide for the treatment of sarcopenic obesity.


Lead Product(s): Enobosarm,Semaglutide

Therapeutic Area: Nutrition and Weight Loss Product Name: Ostarine

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 30, 2024

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VERU-024 (enobosarm) is a novel oral daily selective androgen receptor modulator.


Lead Product(s): Enobosarm,GLP-1 receptor agonist

Therapeutic Area: Nutrition and Weight Loss Product Name: VERU-024

Highest Development Status: Phase IProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 06, 2024

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VERU-024 (enobosarm) is a novel selective androgen receptor modulator which is beig evaluated in preclinical studies to prevent muscle loss while augmenting fat loss in combination with GLP-1 drugs for weight loss.


Lead Product(s): Enobosarm,Undisclosed

Therapeutic Area: Nutrition and Weight Loss Product Name: VERU-024

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 January 08, 2024

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Veru intends to use the proceeds to fund its clinical stage drug development, including a Phase 2b trial to evaluate VERU-024 (enobosarm), an oral selective androgen receptor modulator, for the treatment to augment fat loss and to prevent muscle loss in sarcopenic obese.


Lead Product(s): Enobosarm,Undisclosed

Therapeutic Area: Nutrition and Weight Loss Product Name: VERU-024

Highest Development Status: IND EnablingProduct Type: Small molecule

Partner/Sponsor/Collaborator: Raymond James & Associates

Deal Size: $33.0 million Upfront Cash: Undisclosed

Deal Type: Public Offering December 14, 2023

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Veru intends to use the proceeds to fund its clinical stage drug development, including a Phase 2b trial to evaluate VERU-024 (enobosarm), an oral selective androgen receptor modulator, for the treatment to augment fat loss and to prevent muscle loss in sarcopenic obese.


Lead Product(s): Enobosarm,Undisclosed

Therapeutic Area: Nutrition and Weight Loss Product Name: VERU-024

Highest Development Status: IND EnablingProduct Type: Small molecule

Partner/Sponsor/Collaborator: Raymond James & Associates

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Public Offering December 13, 2023

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VERU-024 (enobosarm), a selective androgen receptor modulator, into a Phase 2b clinical trial in combination with semaglutide to evaluate the efficacy and the safety of enobosarm to further increase fat loss.


Lead Product(s): Enobosarm,Abemaciclib,Tirzepatide

Therapeutic Area: Nutrition and Weight Loss Product Name: VERU-024

Highest Development Status: Phase IProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 04, 2023

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VERU-024 (enobosarm), a first-in-class, oral, non-steroidal, selective androgen receptor agonist, which is investigating for the treatment of metastatic setting of AR+ER+HER2- breast cancer.


Lead Product(s): Enobosarm,Abemaciclib

Therapeutic Area: Oncology Product Name: VERU-024

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Eli Lilly

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 11, 2023

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  • Deals

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The funding will be used to develop oncology therapeutics for indications of high unmet need, including VERU-024 (enobosarm), a first-in-class, oral, non-steroidal, selective androgen receptor agonist.


Lead Product(s): Enobosarm,Abemaciclib

Therapeutic Area: Oncology Product Name: VERU-024

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: U.S. Department of Defense

Deal Size: $3.9 million Upfront Cash: Undisclosed

Deal Type: Funding June 21, 2023

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Verzenio® (abemaciclib), is a targeted treatment known as CDK4/6 inhibitor. Verzenio is a non-chemotherapy oral tablet. Verzenio works inside the cell to block CDK4/6 activity and help stop the growth of cancer cells, so they may eventually die (based on preclinical studies).


Lead Product(s): Abemaciclib,Enobosarm

Therapeutic Area: Oncology Product Name: Verzenio

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Eli Lilly

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 31, 2022

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Enobosarm is an oral, first-in-class, new chemical entity, selective androgen receptor targeting agonist that activates AR, a tumor suppressor, in AR+ ER+ HER2- metastatic breast cancer without unwanted masculinizing side effects.


Lead Product(s): Enobosarm

Therapeutic Area: Oncology Product Name: VERU-024

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 04, 2022

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The objective of the collaboration is to evaluate the efficacy and safety of enobosarm, Veru’s, selective androgen receptor targeting agonist, in combination with Lilly’s Verzenio (abemaciclib), a CDK4/6 inhibitor, as a treatment of AR+ER+HER2- metastatic breast cancer.


Lead Product(s): Abemaciclib,Enobosarm

Therapeutic Area: Oncology Product Name: Verzenio

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Eli Lilly

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Collaboration February 01, 2022

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Details:

Enobosarm is being targeted to patients with positive androgen receptor staining using a threshold of ≥ 40% nuclei staining in tissue samples using a diagnostic test being developed and validated as a companion diagnostic test.


Lead Product(s): Enobosarm

Therapeutic Area: Oncology Product Name: GTx-024

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 13, 2021

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  • Development Update

Details:

Preclinical studies support Enobosarm’s novel mechanism of action as an AR Activating Agent as a Potential Therapy in patients with ER+ metastatic breast cancer that have become resistant to current standard of care treatments.


Lead Product(s): Enobosarm

Therapeutic Area: Oncology Product Name: GTx-024

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Veru

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 19, 2021

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Enobosarm demonstrated clinically meaningful clinical benefit rates, overall response rates, median radiographic progression-free survival and well tolerated safety profile in heavily pretreated endocrine and chemotherapy resistant metastatic breast cancer cohorts.


Lead Product(s): Enobosarm

Therapeutic Area: Oncology Product Name: GTx-024

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 14, 2020

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