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Canada's thumbs-up for Amtagvi
Just after market close Monday, Iovance announced that its cancer drug Amtagvi had been conditionally approved in Canada for treatment of certain forms of unresectable or metastatic melanoma. This green light from Health Canada, the country's medical regulator, is the biotech's first approval outside its native U.S.
Image source: Getty Images.
Final approval is conditional upon the results of late-stage clinical trials being conducted by the company. It added that it expects to authorize its first specialized treatment center in Canada in order to administer the medicine. It intends to do this at some point in the coming months.
Iovance hopes to win approvals for Amtagvi in other jurisdictions with high instances of advanced melanoma specifically, and solid-tumor cancers generally.
The drug earned approval from the U.S. Food and Drug Administration (FDA) for a similar indication in February 2024. It was the first cellular therapy to get the FDA's nod.
Positive momentum
Tuesday morning, H.C. Wainwright analyst Joseph Pantginis reiterated his buy recommendation on Iovance and his $20 per share price target.
Not surprisingly, Pantginis' update was focused on the Health Canada move, according to reports. He wrote that it could be something of an inflection point for the healthcare company because Amtagvi will start producing a new revenue stream after final approval and boost the chances of a green light in other jurisdictions.
