On Monday, H.C. Wainwright maintained its Buy rating and $32.00 price target for Iovance Biotherapeutics (NASDAQ:IOVA) stock, a company listed on NASDAQ:IOVA. This follows Iovance's announcement on June 28 that it has submitted a marketing authorization application to the European Medicines Agency for its cancer treatment, lifileucel.
The company is seeking approval for lifileucel to treat adults with unresectable or metastatic melanoma who have previously undergone treatment with a PD-1 blocking antibody and, in cases where the BRAF V600 mutation is positive, a BRAF inhibitor with or without a MEK inhibitor.
Iovance reported that lifileucel could become the first and only approved therapy for this particular treatment setting in the European Union if the application is successful. The company anticipates the MAA's possible validation in the third quarter of 2024. The Committee for Medicinal Products for Human Use is expected to deliver a scientific opinion for the European Commission's adoption as early as 2025.
The company's strategic plan includes expanding TIL therapy into global markets, which is considered a significant area of potential growth. Iovance's efforts to gain approval in the United States were marked as a significant milestone, and the firm believes that similar regulatory success is likely in the European Union, as well as in other regions such as the United Kingdom, Canada, and Australia. Marketing submissions in these additional regions are planned for the second half of 2024 and in Australia in 2025.
H.C. Wainwright's reiteration of the Buy rating and price target is based on the robust data portfolio of lifileucel and the company's successful efforts to receive approval in the U.S.
The firm views the expansion of TIL therapy into international markets as a key component of Iovance's commercial strategy, with a high potential for regulatory success and value generation.
In other recent news, Iovance Biotherapeutics reported a net loss of $113 million for the first quarter of 2024, with revenues of $715,000 from Proleukin sales. Despite this, the launch of its advanced melanoma treatment, Amtagvi, has been successful with over 160 patients enrolled and growing demand.
Piper Sandler and Stifel have both maintained their positive ratings on Iovance, citing promising clinical trial results and the potential of Amtagvi. Furthermore, Iovance's Annual Meeting of Stockholders led to the election of seven board members and the approval of key proposals, including amendments to equity plans. These are among the recent developments for the company.
In addition, shareholders endorsed the executive officers' compensation and ratified Ernst & Young LLP as the independent accounting firm for the fiscal year ending December 31, 2024.
The company also increased available shares for the 2018 Equity Incentive Plan and the 2020 Employee Stock Purchase Plan. Piper Sandler's and Stifel's confidence in Iovance's therapies is based on discussions at the recent ASCO meeting and updated clinical trial results, respectively.
These developments indicate a positive outlook for Iovance's therapies and their potential for treating various forms of cancer. However, these projections are based on current data and may change as more information becomes available.
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