Welcome to our dedicated page for Iovance Biotherp news (Ticker: IOVA), a resource for investors and traders seeking the latest updates and insights on Iovance Biotherp stock.
Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) is a biotechnology company focused on innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) cell therapies for patients with cancer. This news page aggregates company announcements, clinical updates, regulatory developments, and financial disclosures related to Iovance’s TIL platform and commercial activities.
Readers can find news about Amtagvi, which Iovance describes as the first FDA-approved T cell therapy for a solid tumor indication, as well as updates on its use in advanced melanoma and other solid tumors. Coverage includes information on Health Canada’s conditional approval of Amtagvi for certain patients with unresectable or metastatic melanoma, and ongoing work to expand access through treatment centers and international markets.
The feed also features interim data from key clinical trials, such as registrational Phase 2 studies of lifileucel in advanced non-small cell lung cancer and other solid tumors, along with reports on next-generation programs like gene-edited TIL therapies and modified IL-2 analogs. Corporate news items include quarterly financial result announcements, conference presentations, equity inducement grants under Nasdaq Listing Rule 5635(c)(4), and capital markets transactions described in SEC filings.
Investors, analysts, and healthcare professionals can use this page to follow how Iovance communicates progress on its TIL pipeline, commercial execution for Amtagvi and Proleukin, and interactions with regulators. Regularly reviewing these updates provides context on the company’s development trajectory and its efforts to advance TIL-based immuno-oncology therapies.
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.
Iovance Biotherapeutics announced its participation in key upcoming conferences aimed at highlighting its innovative T cell-based cancer therapies. The company will present at the Piper Sandler Healthcare Conference on November 30, 2022, followed by the JMP Securities Summit on December 7, 2022, and the J.P. Morgan Healthcare Conference on January 11, 2023. Iovance's lead product, lifileucel, is a pioneering treatment for metastatic melanoma and aims to be the first approved one-time cell therapy for solid tumors. Webcasts of these events will be accessible on their investor relations website.
Iovance Biotherapeutics (NASDAQ: IOVA) announced that its rolling Biologics License Application (BLA) for lifileucel is expected to conclude in Q1 2023. The FDA has provided crucial feedback on the investigational new drug application, which the company will address promptly. Lifileucel, aimed at treating advanced melanoma, currently has no FDA-approved therapy in its category. A successful pre-BLA meeting and ongoing clinical trials further support its potential approval, as Iovance strives to deliver the first individualized cell therapy for this patient group.
Iovance Biotherapeutics announced promising results from its C-144-01 trial for lifileucel, a TIL therapy for advanced melanoma. The trial, featuring 153 patients, reported a 31% objective response rate (ORR) with ongoing responses and a median duration of response not reached at 27.6 months. Median overall survival was 13.9 months. The company is on track to submit a rolling BLA to the FDA by year-end 2022. These results highlight the potential of lifileucel as a significant treatment option in a market currently lacking approved therapies for this patient group.
Iovance Biotherapeutics (NASDAQ: IOVA) initiated a rolling Biologics License Application (BLA) for lifileucel in advanced melanoma, expected to complete in Q4 2022. The company reported a net loss of $99.6 million for Q3 2022, up from $86.1 million in Q3 2021, with R&D expenses rising by 11% to $72.5 million. Their cash position stands at $366.6 million, enough to fund operations into 2024. Iovance aims for FDA approval and commercial launch in 2023, supported by advancements in clinical trials and manufacturing capabilities.
Iovance Biotherapeutics (NASDAQ: IOVA) will announce its Q3 financial results on November 3, 2022. A conference call and live audio webcast will be held at 4:30 p.m. ET for a detailed review and corporate update. Iovance is focused on pioneering T cell-based cancer immunotherapies, specifically targeting metastatic melanoma with its lead candidate, lifileucel, which aims to be the first approved one-time cell therapy for solid tumors. The archived webcast will be available for one year post-event.
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