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Investing.com - H.C. Wainwright has reiterated its Buy rating and $20.00 price target on Iovance Biotherapeutics (NASDAQ:IOVA) following Health Canada’s approval of the company’s AMTAGVI therapy. The stock, currently trading at $2.50, has shown strong momentum with a 12% gain over the past week, according to InvestingPro data.
Health Canada issued a Notice of Compliance with Conditions (NOC/c) for AMTAGVI on Monday, granting market authorization for the treatment in Canada for adult patients with unresectable or metastatic melanoma that has progressed after prior therapies.
AMTAGVI is the first T cell therapy approved for a solid tumor in Canada and the first treatment option approved there for advanced melanoma after anti-PD-1 and targeted therapy, according to H.C. Wainwright.
The Canadian authorization was based on safety and efficacy data from the C-144-01 trial and is conditional pending results of trials to confirm its clinical benefit.
H.C. Wainwright views this development as potentially marking an inflection point for the stock, which has been under pressure in recent months, noting that the Canadian approval provides an additional revenue stream and sets the stage for future international approvals. Despite the stock’s 66% decline year-to-date, five analysts have recently revised their earnings estimates upward for the upcoming period.
In other recent news, Iovance Biotherapeutics reported its financial results for the second quarter of 2025, revealing a revenue miss. The company’s revenue reached $60 million, which fell short of the $67.1 million forecast, resulting in a 10.58% revenue surprise. Additionally, the earnings per share (EPS) came in at -$0.33, slightly below the forecasted -$0.28, marking a 17.86% negative surprise. In other developments, Health Canada granted conditional approval for Iovance Biotherapeutics’ Amtagvi, the first T cell therapy for solid tumor cancer, for the treatment of advanced melanoma. This approval allows Amtagvi to be used in adult patients with unresectable or metastatic melanoma that has progressed after prior systemic therapy. The approval highlights a significant step for the company in expanding its treatment options for cancer patients. These recent developments underscore the company’s ongoing efforts in advancing its product offerings despite financial challenges.
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