Welcome to our dedicated page for Iovance Biotherapeutics news (Ticker: IOVA), a resource for investors and traders seeking the latest updates and insights on Iovance Biotherapeutics stock.
Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) is a clinical-stage biopharmaceutical company dedicated to advancing and commercializing innovative cancer immunotherapies. The company specializes in tumor-infiltrating lymphocyte (TIL) therapies, which harness the body's immune system to target and eliminate cancer cells.
Core Business: Iovance’s primary focus is on developing autologous T-cell therapies designed to treat various solid tumors. Their lead candidate, lifileucel (marketed as AMTAGVI™), has recently gained FDA approval for treating advanced melanoma. This milestone marks it as the first T-cell therapy approved for a solid tumor cancer.
Clinical Trials and Achievements: Lifileucel has shown promise in clinical trials, producing durable responses in patients with metastatic melanoma. Iovance continues to explore its efficacy in other cancers including head and neck carcinoma, cervical cancer, and non-small cell lung cancer through trials like IOV-LUN-202. Preliminary data suggests significant potential benefits, with ongoing responses and durations extending over six months.
Regulatory and Market Footprint: Iovance is preparing for further U.S. regulatory approvals and is working towards global commercialization. The FDA’s recent hold on IOV-LUN-202 due to safety concerns has not affected other trials or the priority review of lifileucel in advanced melanoma.
Manufacturing and Partnerships: With manufacturing facilities like the Iovance Cell Therapy Center (iCTC) and partnerships with entities such as WuXi Advanced Therapies, Iovance is well-equipped to scale production to meet clinical and commercial demands.
Financial Overview: The company reported a net loss of $113.0 million for Q1 2024, reflecting heavy investment in R&D and commercialization efforts. Revenue from Proleukin® sales outside the U.S. contributed $0.7 million, demonstrating ongoing diversification.
Commitment to Innovation: Iovance remains committed to pioneering advancements in cell therapy, including gene-edited approaches, to extend and improve the lives of cancer patients. For more information, please visit www.iovance.com.
Iovance Biotherapeutics (NASDAQ: IOVA), a leader in T cell-based cancer therapies, announced upcoming presentations at key conferences. On April 24, 2023, a fireside chat will take place at Chardan's 7th Annual Genetic Medicine and Cell Therapy Manufacturing Summit. Following this, a chat is scheduled for May 2, 2023, at H.C. Wainwright BioConnect in New York. The JMP Securities Life Sciences Conference will feature a presentation on May 16, 2023. Live and archived webcasts will be available on the company’s investor relations site. Iovance is focused on delivering tumor infiltrating lymphocyte therapies, particularly lifileucel, which shows promise as a one-time treatment for metastatic melanoma. The company is committed to innovating cell therapies to enhance cancer patient outcomes.
Iovance Biotherapeutics has submitted its rolling Biologics License Application (BLA) for lifileucel to the U.S. FDA, marking a significant milestone in the development of T cell-based therapies for cancer.
Lifileucel is aimed at treating patients with advanced melanoma who have not responded to prior therapies. This submission is backed by positive data from the C-144-01 clinical trial.
Iovance plans to support a full approval via the TILVANCE-301 trial, combining lifileucel with pembrolizumab. The FDA has 60 days to review the BLA, with potential for expedited approval.
Iovance Biotherapeutics (NASDAQ: IOVA) announced its participation in multiple upcoming conferences, highlighting its focus on T cell-based cancer immunotherapies. Key events include the H.C. Wainwright Cell Therapy Virtual Conference (February 28), Cowen Health Care Conference (March 7), Oppenheimer 33rd Annual Healthcare Conference (March 14), and Barclays 2023 Global Healthcare Conference (March 15). These presentations aim to showcase Iovance's innovative tumor infiltrating lymphocyte (TIL) therapies, particularly lifileucel for metastatic melanoma. Live and archived webcasts will be accessible on their investor relations webpage.
Iovance Biotherapeutics (NASDAQ: IOVA) reported its fourth quarter and full year 2022 financial results on February 28, 2023, highlighting progress in its BLA submission for lifileucel in advanced melanoma. The company plans to finalize this submission in 1Q23, receiving FDA approval for commercialization. A notable acquisition of Proleukin® aims to enhance revenue, streamline supply chains, and lower clinical costs. Financially, Iovance reported a net loss of $105.3 million for Q4 2022, up from $99.3 million in Q4 2021, while the total annual net loss increased to $395.9 million from $342.3 million. The cash position stands at approximately $669.8 million, sufficient to fund operations through mid-2024.
Iovance Biotherapeutics (NASDAQ: IOVA) will announce its Q4 and full year 2022 financial results on February 28, 2023. A conference call will follow at 4:30 p.m. ET to discuss the results and provide a corporate update. Iovance focuses on developing tumor infiltrating lymphocyte (TIL) cell therapies for solid tumors, with their leading candidate, lifileucel, aimed at treating metastatic melanoma. The company is committed to continuous innovation in cell therapy, including gene-edited variants.
For more details, visit Iovance's website.
Iovance Biotherapeutics announced a definitive agreement to acquire global rights to Proleukin® (aldesleukin) for £166.7 million, enhancing T-cell therapies for cancer treatment. The acquisition is projected to generate immediate and future revenue while securing the IL-2 supply chain. With an unaudited cash position of approximately $477 million, the company is well-positioned financially until 2024. Additionally, positive FDA feedback was received for the Phase 3 TILVANCE-301 trial in advanced melanoma, expected to randomize 670 patients. Lifileucel showed a 47% objective response rate in NSCLC trials, with ongoing enrollment.
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