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) has announced a regulatory update regarding its TIL therapy, lifileucel, for metastatic melanoma. Following discussions with the FDA, the company is refining potency assays required for its Biologics License Application (BLA) submission, which is now expected in 2021 instead of 2020. Clinical trial data shows lifileucel has an overall response rate of 36.4% in Cohort 2, compared to 4-10% for current chemotherapy options. The company emphasizes urgency in addressing unmet patient needs while working closely with the FDA to finalize regulatory requirements.
Iovance Biotherapeutics, a late-stage biotechnology firm, will present at the BTIG Biotechnology Conference 2020 on August 11 at 2:30 PM ET. The event will focus on their T cell-based cancer immunotherapies, particularly Tumor Infiltrating Lymphocyte (TIL) therapy for solid tumors and blood cancers. The company is conducting pivotal studies in metastatic melanoma and advanced cervical cancer, and its TIL therapies are being explored for various cancers. A live webcast will be available on their investor website.
Iovance Biotherapeutics (NASDAQ: IOVA) reported its second quarter 2020 financial results, showing a cash position of $777.4 million as of June 30, compared to $312.5 million at the end of 2019. The net loss was $63 million or $0.47 per share, reflecting an increase from $47.6 million in Q2 2019. Clinical progress includes positive data from the melanoma program for lifileucel, supporting a planned BLA submission. Enrollment completed for cervical cancer studies, with ongoing preparations for commercial launch and CLL/SLL studies.
Iovance Biotherapeutics (NASDAQ: IOVA) will release its Q2 2020 financial results on August 6, 2020, followed by a conference call at 4:30 p.m. EDT. The company, focused on T cell-based cancer therapies, is advancing its pivotal studies for metastatic melanoma and advanced cervical cancer. Iovance’s Tumor Infiltrating Lymphocyte (TIL) therapy aims to leverage patients' own immune cells to combat cancer. The company is also exploring PBL therapy for blood cancers. More information can be found on their website.
Iovance Biotherapeutics announced its participation in two upcoming virtual conferences in June 2020. The company will present at the Goldman Sachs 41st Annual Global Healthcare Conference on June 11 at 3:00 p.m. ET and at the JMP Securities Hematology and Oncology Forum on June 18 at 2:20 p.m. ET. Live and archived webcasts will be accessible on the Iovance Investors website. Iovance focuses on T cell-based immunotherapies for treating solid tumors and blood cancers, including ongoing pivotal studies for metastatic melanoma and advanced cervical cancer.
Iovance Biotherapeutics has successfully closed a public offering of 19,475,806 shares at $31.00 per share, raising $603.7 million in gross proceeds. The company plans to utilize these funds for the potential commercial launch of lifileucel and LN-145 for advanced cancers, and to initiate registration for tumor infiltrating lymphocyte therapies in non-small cell lung cancer. The offering was conducted under a shelf registration statement that became effective on May 27, 2020.
Iovance Biotherapeutics announced a public offering of $500 million in common stock, all to be sold by the company. An additional 30-day option for underwriters to purchase up to $75 million of extra shares is also mentioned. Proceeds from the offering will support the potential commercial launch of lifileucel for advanced melanoma and LN-145 for cervical cancer, as well as ongoing clinical trials and general corporate purposes. The offering will utilize a shelf registration statement filed with the SEC.
Iovance Biotherapeutics (NASDAQ: IOVA) announced new interim data from Cohort 2 of the C-144-01 study of lifileucel for advanced melanoma, to be presented at ASCO 2020. As of February 2020, the median duration of response (DOR) remains unmeasured at a median follow-up of 17 months, with an overall response rate of 36.4% from 66 patients. The adverse event profile aligns with advanced disease and treatment regimens. The presentation will provide further insights into the durable effects of TIL therapy in heavily pretreated patients. Future updates are anticipated following the ASCO event.
Iovance Biotherapeutics (NASDAQ: IOVA) reported Q1 2020 results, posting a net loss of $69.6 million, or $0.55 per share, up from a net loss of $37.0 million, or $0.30 per share in Q1 2019. R&D expenses surged to $57.0 million due to increased clinical trials and licensing costs. The company held $251.2 million in cash at March 31, 2020. Iovance remains committed to commercializing TIL therapies for melanoma and cervical cancer, with pivotal study enrollments progressing ahead of schedule, and plans for a BLA submission in late 2020.
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