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 the approval of inducement stock options for 48 new, non-executive employees on December 19, 2024. The grants cover 203,980 shares of common stock with an exercise price of $7.22 per share, matching the closing price on the grant date. These options were awarded under the company's Amended and Restated 2021 Inducement Plan, following Nasdaq Listing Rule 5635(c)(4). The options feature a three-year vesting schedule, with one-third vesting on the first employment anniversary and the remaining portions vesting quarterly over the following two years.
Iovance Biotherapeutics (NASDAQ: IOVA) has promoted Dr. Raj Puri to the newly created position of Chief Regulatory Officer. Dr. Puri, who joined Iovance in March 2022 as Executive Vice President of Regulatory Strategy and Translational Medicine, played a key role in securing regulatory approval for Amtagvi™ in the United States and advancing submissions in multiple international markets. The company aims to address more than 20,000 patients annually with previously treated advanced melanoma starting in 2025. Dr. Puri brings over 33 years of FDA experience, including 19 years as director of the Division of Cellular and Gene Therapies in the FDA's Center for Biologics Evaluation and Research.
Iovance Biotherapeutics reported strong Q3 2024 results with $58.6M in total product revenue, including $42.1M from Amtagvi and $16.5M from Proleukin sales. The company reaffirmed its guidance of $160-165M for FY24 and $450-475M for FY25 in total product revenue. Since Amtagvi's launch in February 2024, 146 patients have been infused, with 82 in Q3 alone. The company has $403.8M in cash position, expected to fund operations into early 2026. Marketing applications for Amtagvi are under review in the UK, EU, and Canada, with potential approvals starting in 1H2025.
Iovance Biotherapeutics (NASDAQ: IOVA) has announced it will report its third quarter and year-to-date 2024 financial results on Thursday, November 7, 2024, followed by a conference call and webcast at 4:30 p.m. EST. The company will also participate in two major events: the Society for Immunotherapy of Cancer (SITC) 2024 in Houston from November 6-10, where they will present research on lifileucel TIL products and IL12-engineered TIL IOV-5001, and the Stifel 2024 Healthcare Conference on November 19, featuring a fireside chat with senior leadership.
Iovance Biotherapeutics (NASDAQ: IOVA), a biotech company specializing in novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for cancer patients, has announced its participation in three upcoming conferences. The company's senior leadership will be presenting at:
1. Wells Fargo Healthcare Conference in Boston on September 4, 2024, at 3:45 p.m. ET
2. Baird Global Healthcare Conference in New York on September 10, 2024, at 2:35 p.m. ET
3. H.C. Wainwright Global Investment Conference in New York on September 11, 2024, at 11:00 a.m. ET
Live and archived webcasts of these presentations will be accessible on the Iovance website at https://ir.iovance.com/news-events/events-presentations.
Iovance Biotherapeutics (NASDAQ: IOVA), a biotechnology company specializing in novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for cancer patients, has announced the granting of inducement stock options and restricted stock units. On August 15, 2024, the company approved awards covering 289,710 shares of common stock to 24 new, non-executive employees under its 2021 Inducement Plan.
The stock options have an exercise price of $10.67, matching the closing price of Iovance's common stock on the grant date. Both stock options and restricted stock units follow a three-year vesting schedule, with one-third vesting on the first anniversary of the employee's start date and the remaining shares vesting in eight quarterly installments over the following two years, contingent on continued employment.
Iovance Biotherapeutics reported strong Q2 2024 results, with total product revenue of $31.1 million. This includes $12.8 million from Amtagvi, their newly launched TIL therapy for advanced melanoma, and $18.3 million from Proleukin. The company provided guidance for Q3 2024 total product revenue of $53-$55 million, FY 2024 revenue of $160-$165 million, and FY 2025 revenue of $450-$475 million.
Iovance has $449.6 million in cash as of July 24, 2024, expected to fund operations into early 2026. The Amtagvi launch is progressing well, with over 55 patients infused since April 2024. The company is expanding its manufacturing capacity and advancing its clinical pipeline in multiple indications.
Iovance Biotherapeutics (NASDAQ: IOVA), a biotech company specializing in novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for cancer patients, has announced its upcoming second quarter and first half 2024 financial results conference call. The event is scheduled for Thursday, August 8, 2024, at 4:30 p.m. ET. Management will present the financial results and provide a corporate update during the call.
Investors and interested parties can access the live audio webcast by registering at the provided link. The webcast will also be archived and available for one year in the Investors section of the Iovance website. This event offers an opportunity for stakeholders to gain insights into the company's financial performance and recent developments in its innovative cancer therapies.
Iovance Biotherapeutics (NASDAQ: IOVA), a biotechnology company focused on developing novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for cancer patients, has announced the grant of inducement stock options to 19 new, non-executive employees. The grants, approved on July 18, 2024, cover an aggregate of 106,010 shares of Iovance's common stock.
These awards were granted under Iovance's 2021 Inducement Plan, which was adopted on September 22, 2021, and subsequently amended. Each stock option has an exercise price of $8.31, matching the closing price of Iovance's common stock on the grant date. The options vest over a three-year period, with one-third vesting on the first anniversary of the employee's start date and the remaining shares vesting in eight quarterly installments over the next two years.
Iovance Biotherapeutics has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for lifileucel, a novel TIL cell therapy, to treat adults with unresectable or metastatic melanoma previously treated with a PD-1 blocker and, if applicable, a BRAF inhibitor. If approved, lifileucel would be the first and only therapy available for this indication across the EU. This submission follows positive clinical trial results from the C-144-01 study. The EMA’s Committee for Medicinal Products for Human Use (CHMP) is expected to issue a decision in 2025. Further global submissions are planned in Canada, the UK, and Australia by 2025, aiming to address over 20,000 annual advanced melanoma cases in these regions.
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