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Latest From Emily Hayes
La Jolla Pharmaceutical's angiotensin II drug LJPC-501 is on track for NDA via SPA this year, after meeting blood pressure increase primary endpoint in ATHOS-3, but also showing a trend toward an overall survival benefit.
Company plans to pursue accelerated approval based on a single-arm registrational study of PD-1 failures, after reporting positive results from a Phase II study at the ASCO-SITC meeting.
The company will talk to regulators in the US and Europe to see if the drug could be considered in elderly patients with low baseline peripheral white blood cells, who fared better than others in the failed SEAMLESS study.
Argos mum on details surrounding Phase III failure of rocapuldencel-T in kidney cancer, while Agenus distances itself from failed Phase II glioblastoma study of Prophage G-200 as an investigator-sponsored trial with a challenging design.
A mixed bag of safety results for the new opioid Olinvo (oliceridine) in the Phase III APOLLO pain trials disappoints the market, but analysts are encouraged by the totality of the data and optimistic about approval.
HIV may be effectively treated and managed with available therapies, but there is still great unmet need for a functional cure and better prevention to stop the epidemic.