Progenics Pharmaceuticals, Inc. develops medicines and other products for targeting and treating cancer. Clinical-Stage Product Candidates The company’s principal clinical-stage product candidates in oncology include: AZEDRA is a radiotherapeutic product candidate in development as a treatment for malignant and/or recurrent pheochromocytoma and paraganglioma, rare tumors found in the adrenal glands and outside of the adrenal glands, respectively. AZEDRA has been granted Breakthrough Therapy and Orphan Drug designations, as well as Fast Track status in the U.S. Under Special Protocol Assessment agreement with the U.S. Food and Drug Administration (FDA), a Phase 2 registrational study is being conducted in patients with malignant and/or recurrent pheochromocytoma and paraganglioma. 1404 (trofolastat) is a technetium-99m labeled small molecule, which binds prostate specific membrane antigen (PSMA) and is used as an imaging agent to diagnose and detect localized prostate cancer, as well as soft tissue and bone metastases. The company completed a global multi-centered Phase 2 study assessing the diagnostic accuracy of 1404 imaging in men with high-risk prostate cancer and initiated a multi-center, open-label Phase 3 trial to determine the sensitivity and specificity of 1404 to correctly identify whether or not patients have clinically significant prostate cancer. PyL (also known as [18F]DCFPyL) is a clinical-stage, fluorinated PSMA-targeted positron emission topography (PET) imaging agent for prostate cancer that was discovered and developed at the Center for Translational Molecular Imaging at the Johns Hopkins University School of Medicine. 1095 is a PSMA-targeted Iodine-131 labeled small radiopharmaceutical molecule that is designed to deliver a dose of radiation directly to prostate cancer cells with minimal impact on the surrounding healthy tissues. In collaboration with Memorial Sloan-Kettering Cancer Center, the company plans to submit an Investigational New Drug application in the U.S. and initiate a Phase 1 clinical study. PSMA ADC is a fully human monoclonal antibody-drug conjugate designed to deliver a chemotherapeutic agent to cancer. A Phase 2, multicenter clinical trial to assess the safety, tolerability and anti-tumor activity of PSMA ADC has been completed in both the chemotherapy refractory and chemotherapy naïve patients with metastatic castration-resistant prostate cancer (mCRPC). Partnered Products RELISTOR is the first approved treatment for opioid-induced constipation (OIC) that addresses its underlying mechanism, decreases the constipating side effects induced by opioid pain medications, such as morphine and codeine without diminishing their ability to relieve pain. RELISTOR subcutaneous injection is approved for sale in the U.S., E.U., Canada, Australia and elsewhere in single-use vials and pre-filled syringes, which are designed to ease preparation and administration for patients and caregivers. Under the company’s license agreement, Valeant Pharmaceuticals International, Inc. (Valeant) is responsible for developing and commercializing RELISTOR, including completing clinical development necessary to support regulatory marketing approvals for potential new formulations of the drug (such as an oral formulation of methylnaltrexone, the active ingredient in RELISTOR). RELISTOR was originally approved in 2008 for OIC in patients with advanced illness and in September 2014, received approval from the FDA for the treatment of OIC in patients taking opioids for chronic non-cancer pain. Valeant markets RELISTOR directly through its specialty sales force in the U.S., and outside the U.S. directly through distribution and marketing partners. PRO 140 is a fully humanized IgG4 monoclonal antibody directed against CCR5, a molecular portal that HIV uses to enter T-cells. PRO 140 blocks the predominant HIV subtype (R5) entry into T-cells by masking this required co-receptor, CCR5. PRO 140 has been the subject of seven clinical trials, each demonstrating efficacy by significantly reducing or controlling HIV viral load in human test subjects. PRO 140 has been designated a ‘fast track’ pro
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