NORTH BILLERICA, Mass.--(BUSINESS WIRE)--Lantheus Holdings, Inc. (NASDAQ: LNTH) (Lantheus), an established leader and fully integrated provider of innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to Find, Fight and Follow serious medical conditions, today announced the publication of the results of both pivotal studies for PyL™, an investigational PET imaging agent that targets prostate-specific membrane antigen (PSMA). The OSPREY Phase 2/3 trial results have been published online in the Journal of Urology and the CONDOR Phase 3 trial results have been published in the online version of Clinical Cancer Research.
San Francisco, CA (UroToday.com) -- Lantheus Holdings, Inc. (Lantheus), the parent company of Lantheus Medical Imaging, Inc. and Progenics Pharmaceuticals, Inc., a global leader in the development, manufacture, and commercialization of innovative diagnostic imaging agents and products, announced it has entered into a strategic collaboration with POINT Biopharma, Inc. (POINT) to use Lantheus’ investigational prostate-specific membrane antigen (PSMA)-targeted positron emission tomography (PET) imaging agent, PyL, to determine PSMA-avidity during patient selection in POINT’s Phase 3 clinical trial to treat metastatic castration-resistant prostate cancer (mCRPC). The collaboration directly aligns with an important Lantheus strategy to advance cancer precision medicine by enabling partners to use PyL in prostate cancer therapeutic trials.
NORTH BILLERICA, Mass.--(BUSINESS WIRE)--Lantheus Holdings, Inc. (NASDAQ: LNTH) (the Company), the parent company of Lantheus Medical Imaging, Inc. and Progenics Pharmaceuticals, Inc., and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products, today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for PyLTM (18F-DCFPyL), a prostate specific membrane antigen (PSMA)-targeted positron emission tomography (PET) imaging agent for prostate cancer.
NORTH BILLERICA, Mass.--(BUSINESS WIRE)--Lantheus Holdings, Inc. (the “Company”) (NASDAQ: LNTH), the parent company of Lantheus Medical Imaging, Inc., Progenics Pharmaceuticals, Inc., and EXINI Diagnostics AB, and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products, today announced that two abstracts featuring data from the Company’s prostate specific membrane antigen artificial intelligence (PSMA AI) tool will be presented at the upcoming European Association of Nuclear Medicine (EAMN) Virtual Congress, which will be held from October 22-30, 2020. Details on the presentations are included below.
NORTH BILLERICA, Mass.--(BUSINESS WIRE)--Lantheus Holdings, Inc. (the “Company”) (NASDAQ: LNTH), the parent company of Lantheus Medical Imaging, Inc. and Progenics Pharmaceuticals, Inc., and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products, today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for PyL™ (18F-DCFPyL), a prostate specific membrane antigen (PSMA)-targeted positron emission tomography (PET) imaging agent for prostate cancer. The NDA includes a request for Priority Review, which if granted, could shorten the FDA’s review of the NDA to six months from the time of acceptance, versus the standard review timeline of 10 months from acceptance. The Company expects to receive notification from the FDA confirming acceptance of the filing for substantive review in early December 2020.
Lantheus Holdings (NASDAQ:LNTH), which merged with Progenics Pharmaceuticals (NASDAQ:PGNX) in June, announces the filing of a U.S. marketing application seeking approval of PyL (18-F DCFPyL), a prostate-specific membrane antigen (PSMA)-targeted positron emission tomography (PET) imaging agent for prostate cancer.
NORTH BILLERICA, Mass.--(BUSINESS WIRE)--Lantheus Holdings, Inc. (the “Company”) (NASDAQ: LNTH), the parent company of Lantheus Medical Imaging, Inc. and Progenics Pharmaceuticals, Inc., and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products, today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for PyL™ (18F-DCFPyL), a prostate specific membrane antigen (PSMA)-targeted positron emission tomography (PET) imaging agent for prostate cancer. The NDA includes a request for Priority Review, which if granted, could shorten the FDA’s review of the NDA to six months from the time of acceptance, versus the standard review timeline of 10 months from acceptance. The Company expects to receive notification from the FDA confirming acceptance of the filing for substantive review in early December 2020.
NORTH BILLERICA, Mass. & NEW YORK--(BUSINESS WIRE)--Lantheus Holdings, Inc. (NASDAQ: LNTH) (“Lantheus”), parent company of Lantheus Medical Imaging, Inc. (“LMI”), a leader in the development, manufacture and commercialization of innovative diagnostic imaging agents and products, and Progenics Pharmaceuticals, Inc. (NASDAQ: PGNX) (“Progenics”), an oncology company developing innovative medicines and artificial intelligence to find, fight and follow cancer, today announced that Lantheus has entered into a Support Agreement (the “Support Agreement”) with Velan Capital (“Velan”) in connection with the proposed merger of Lantheus and Progenics.