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) announced it will report its Q1 2022 financial results on May 5, 2022. A conference call will follow at 4:30 p.m. ET for management to discuss results and provide corporate updates. The company is focused on pioneering T cell-based cancer therapies, particularly its lead candidate lifileucel for metastatic melanoma, aiming for it to be the first approved one-time cell therapy for solid tumors. Iovance highlights its commitment to innovation in cancer treatment.
Iovance Biotherapeutics, a late-stage biotechnology firm specializing in T cell-based cancer immunotherapies, announced its participation in the Chardan Genetic Medicines and Cell Therapy Manufacturing Summit. The presentation featuring senior leadership will take place on April 26, 2022, at 1:30 p.m. ET. This event aims to showcase advancements in tumor infiltrating lymphocyte (TIL) therapies, with the company's lead candidate, lifileucel, being a potential first approved one-time cell therapy for solid tumors. The webcast will be accessible for live and archived viewing.
Iovance Biotherapeutics has granted inducement stock options for 323,675 shares to 34 new non-executive employees under its 2021 Inducement Plan. Each option has an exercise price of $16.07 and vests over three years, promoting long-term employee retention. The plan aligns with Nasdaq rules and aims to enhance the company's workforce as it develops T cell-based cancer therapies, including lifileucel for metastatic melanoma. Iovance's focus on innovative cell therapies highlights its commitment to improving cancer treatment.
Iovance Biotherapeutics announced positive FDA feedback on April 1, 2022, regarding its potency assay matrix for the upcoming Biologics License Application (BLA) for lifileucel, a treatment for metastatic melanoma. With this feedback, Iovance plans to request a pre-BLA meeting in July 2022 and aims to submit the BLA by August 2022. In addition, the company will initiate a Phase III study of lifileucel combined with pembrolizumab, demonstrating a 67% overall response rate in prior trials. The FDA granted Fast Track Designation for this combination due to its potential advantages.
Iovance Biotherapeutics announced its participation in key healthcare conferences in March 2022. The schedule includes:
- Oppenheimer Healthcare Conference: Fireside Chat on March 16 at 12:40 p.m. ET
- Barclays Global Healthcare Conference: Fireside Chat on March 17 at 10:45 a.m. ET
Live and archived webcasts will be available on Iovance's investor calendar. The company is focused on pioneering T cell-based cancer immunotherapies, particularly lifileucel for metastatic melanoma.
Iovance Biotherapeutics (NASDAQ: IOVA) announced on March 14, 2022, the approval of inducement stock options and restricted stock units covering 667,725 shares to nineteen new non-executive employees. These awards were granted under the 2021 Inducement Plan, which complies with Nasdaq Listing Rule 5635(c)(4). The options have an exercise price of $12.38, and vesting occurs over three years. This initiative aims to attract talent to enhance Iovance's development of T cell-based cancer therapies, particularly its lead candidate, lifileucel, for metastatic melanoma.
Iovance Biotherapeutics announced that the FDA has approved an Investigational New Drug Application for IOV-4001, its first genetically modified TIL therapy, aimed at treating unresectable metastatic melanoma and stage III or IV NSCLC.
This therapy utilizes TALEN® gene-editing technology licensed from Cellectis to target the PD-1 protein, potentially improving T cell response against cancer. A clinical study is set to commence in 2022, marking a significant milestone in Iovance's TIL platform development.
Iovance Biotherapeutics (NASDAQ: IOVA) announced the acceptance of two abstracts for presentation at the AACR 2022 Annual Meeting, scheduled for April 8-13, 2022, in New Orleans, Louisiana, and virtually. The first abstract focuses on the preclinical activity of genetically modified PDCD-1 knockout TIL cell therapy, presented by Arvind Natarajan. The second abstract highlights a Phase 2 multicenter trial (IOV-LUN-202) of autologous TIL therapy in metastatic non-small cell lung cancer, presented by Jason Alan Chesney. Posters will be available from April 8 in the Virtual ePoster Hall.
Iovance Biotherapeutics reported its fourth quarter and full year 2021 results, highlighting continued advancements in TIL therapy for various solid tumors, notably melanoma and non-small cell lung cancer. The FDA granted fast track designation for lifileucel combined with pembrolizumab in metastatic melanoma. However, the company experienced a net loss of $99.3 million for Q4 2021 and $342.3 million for the full year, with rising R&D and administrative expenses. Iovance ended 2021 with a cash position of $602.1 million, projected to sustain operations into 2024.
Iovance Biotherapeutics announced the approval of stock options for 138,575 shares to nineteen new non-executive employees on February 17, 2022, under its 2021 Inducement Plan. The options, priced at $16.34 per share, will vest over three years, with one-third vesting on the first anniversary of each employee's start date. Iovance focuses on T cell-based cancer immunotherapy, aiming to deliver innovative treatments for solid tumors. The company’s lead candidate, lifileucel, shows potential to be the first approved one-time cell therapy for metastatic melanoma.
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