The approval from Health Canada is conditional, pending results of trials to confirm the immunotherapy’s clinical benefit.
Shares of Iovance Biotherapeutics Inc. (IOVA) traded 4% higher on Tuesday morning after Health Canada approved the company’s immunotherapy for the treatment of advanced melanoma.
On Stocktwits, retail sentiment around IOVA rose from ‘bearish’ to ‘neutral’ territory over the past 24 hours while message volume remained at ‘low’ levels. According to Stocktwits data, retail chatter around IOVA jumped 782% over the past 24 hours as of Tuesday’s early hours and by 87% over the past seven days.
A Stocktwits user opined that the stock would have risen further had it not been for an overall market downturn and said that ‘patience will pay off.’
Iovance’s Amtagvi is a T-cell immunotherapy for the treatment of adult patients with unresectable or metastatic melanoma that has progressed on or after at least one prior systemic therapy and who have no satisfactory alternative treatment options. Advanced melanoma, also known as metastatic melanoma, refers to melanoma that has spread from the original site to other parts of the body.
The marketing authorization in Canada was granted based on the safety and efficacy results from a mid-stage trial. The approval is conditional, pending results of trials to confirm its clinical benefit. However, for Iovance, the approval marks its first outside the U.S. “We expect to authorize our first Canadian treatment center within the next few months, and we continue to advance our ex-U.S. strategy for Amtagvi in additional markets,” said CEO Frederick Vogt.
Iovance is also investigating Amtagvi in frontline advanced melanoma in a late-stage trial, as well as in additional solid tumor types. IOVA stock is down by 65% this year and by about 77% over the past 12 months.
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