SAN CARLOS, Calif. - Iovance Biotherapeutics, Inc. (NASDAQ: NASDAQ:IOVA), a biotech company specializing in novel cancer therapies, has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for its cell therapy product, lifileucel, targeting advanced melanoma.
The treatment is designed for patients who have not responded to existing therapies, including a PD-1 blocking antibody, and, if applicable, a BRAF inhibitor with or without a MEK inhibitor.
The application, if validated, could see the EMA's Committee for Medicinal Products for Human Use (CHMP) deliver a scientific opinion by 2025, potentially making lifileucel the first approved therapy in the European Union for this patient group. The submission is based on positive results from the C-144-01 clinical trial, which focused on patients with advanced melanoma post-anti-PD1 treatment.
Raj K. Puri, M.D., Ph.D., Executive Vice President at Iovance, expressed confidence in the strength of the clinical data supporting the application and the potential of lifileucel to address the unmet needs of advanced melanoma patients in the EU. This step is part of the company's strategy to expand globally, aiming to reach a significant number of the more than 20,000 patients dying annually from advanced melanoma in the U.S., EU, and other regions.
The company, which has already secured accelerated approval in the U.S., plans to submit additional marketing applications for lifileucel in Canada and the United Kingdom in the latter half of 2024 and in Australia in 2025.
This news is based on a press release statement from Iovance Biotherapeutics, Inc. The company's broader mission is to innovate and deliver tumor infiltrating lymphocyte (TIL) therapies for cancer patients, with the TIL platform showing promise across multiple solid tumors. Its first FDA-approved T cell therapy for a solid tumor indication is Amtagvi™.
The forward-looking statements in the press release are subject to various risks and uncertainties, including the possibility of delayed or denied regulatory approvals, market acceptance, and manufacturing challenges. These factors could materially affect the actual results and the commercial potential of lifileucel.
In other recent news, Iovance Biotherapeutics reported a net loss of $113 million for the first quarter of 2024, despite revenues of $715,000 from Proleukin sales. Still, the successful launch of its advanced melanoma treatment, Amtagvi, has seen over 160 patients enrolled and growing demand.
In recent developments, Piper Sandler maintained an Overweight rating for Iovance, expressing optimism about the potential of Amtagvi. Stifel also maintained its Buy rating for the company, following the presentation of promising clinical trial results for Iovance's cancer treatment, lifileucel.
In the company's annual meeting, shareholders approved key proposals, including the election of directors and amendments to equity plans. They also ratified the appointment of Ernst & Young LLP as the independent accounting firm for the fiscal year ending December 31, 2024.
Two significant amendments were approved: an increase in available shares for the 2018 Equity Incentive Plan and the 2020 Employee Stock Purchase Plan.
Analyst firm Piper Sandler reiterated its Overweight rating on Iovance, citing the upcoming update at the American Society of Clinical Oncology regarding Iovance's Phase II trial, IOV-COM-202. Similarly, Stifel maintained its confident stance based on the current clinical evidence for lifileucel. These recent developments indicate a positive outlook for Iovance's therapies and their potential for treating various forms of cancer.
InvestingPro Insights
As Iovance Biotherapeutics (NASDAQ: IOVA) moves forward with its strategic global expansion and seeks approval for lifileucel, its novel cancer therapy, the financial landscape of the company offers a mix of challenges and potential.
According to InvestingPro data, the company currently holds a market capitalization of $2.24 billion USD. Despite a tough financial year with a negative gross profit margin of -846.22% for the last twelve months as of Q1 2024, the company's cash position is robust, with cash reserves outweighing its debt, which is a positive sign for its financial stability.
With the anticipation of sales growth in the current year, as highlighted by InvestingPro Tips, Iovance Biotherapeutics might be poised to make significant strides if lifileucel gains market approval. Still, analysts are not expecting the company to be profitable this year, and the stock has experienced a notable decline over the last month, with a 17.42% drop in price total return. This underscores the importance of the upcoming decisions by regulatory agencies on the company's lead product.
For investors looking to delve deeper into the financial health and future prospects of Iovance Biotherapeutics, there are additional InvestingPro Tips available at https://www.investing.com/pro/IOVA. With a total of 11 tips listed, these insights can provide a more comprehensive understanding of the company's position and outlook. For those interested in accessing these tips, use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription, offering even more value to your investment research.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.