Iovance Biotherapeutics: Canadian Approval and Analyst Optimism

Iovance Biotherapeutics (IOVA) stock surged 24% after receiving conditional approval from Health Canada for its T-cell immunotherapy, Amtagvi, for advanced melanoma. Analysts project a 264% upside potential and have given an "Outperform" rating. IOVA has a one-year average target price of $9.10, ranging from $1.00 to $20.00.

Iovance Biotherapeutics (IOVA) stock experienced a significant increase of 24% following Health Canada's conditional approval for its T-cell immunotherapy, Amtagvi, for advanced melanoma. The approval marks a milestone in the company's strategy to expand its presence in markets with a high prevalence of advanced melanoma and addresses substantial unmet needs in solid tumor cancers.

The approval, based on robust safety and efficacy results from the global C-144-01 clinical trial, supports Iovance's goal of bringing innovative cancer treatments to patients who have not responded to prior systemic therapies. Amtagvi is indicated for adult patients with unresectable or metastatic melanoma that has progressed on or after at least one prior systemic therapy, including a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor, with no satisfactory alternative treatment options.

Health Canada granted the Notice of Compliance with Conditions (NOC/c) based on the results of the C-144-01 clinical trial, a global, multicenter Phase 2 study. The trial enrolled patients with metastatic melanoma previously treated with at least one systemic therapy, including a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor or BRAF inhibitor with MEK inhibitor. Efficacy was established based on objective response rate (ORR) and duration of response (DOR) by Independent Review Committee (IRC) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Analysts have responded positively to the news, projecting a 264% upside potential and giving an "Outperform" rating to IOVA stock. The one-year average target price is $9.10, ranging from $1.00 to $20.00. Wells Fargo, Chardan Capital, Barclays, Goldman Sachs, Mizuho, HC Wainwright & Co., and Truist Securities are among the firms that have issued buy ratings on IOVA stock.

Iovance plans to authorize its first Canadian treatment center within the next few months to facilitate patient access. The company is also exploring additional international markets for Amtagvi. The market authorization in Canada is conditional, pending the results of trials to confirm its clinical benefit, which may raise concerns about the therapy's efficacy and reliability.

References:

[1] https://www.quiverquant.com/news/Iovance+Biotherapeutics+Receives+Health+Canada+Approval+for+Amtagvi%C2%AE+T+Cell+Therapy+for+Advanced+Melanoma