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Iovance Biotherapeutics, Inc. - IOVA STOCK NEWS

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.

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Iovance Biotherapeutics (NASDAQ: IOVA) will release its Q4 and full-year financial results on February 24, 2022, with a conference call at 4:30 p.m. ET. The company is focused on developing T cell-based cancer immunotherapies, particularly its lead product candidate, lifileucel, for metastatic melanoma, potentially becoming the first approved one-time cell therapy for solid tumors. The press release emphasizes ongoing innovation in cell therapy and highlights Iovance's commitment to improving cancer treatment.

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Iovance Biotherapeutics announced the grant of 117,000 inducement stock options to 13 new non-executive employees as part of its 2021 Inducement Plan. The options were priced at $14.04, the closing stock price on January 21, 2022. Each option vests over three years, with one-third vesting on the first anniversary of the employee's start date and the remainder in quarterly installments. This action aligns with Nasdaq Listing Rule 5635(c)(4) and is part of Iovance's commitment to attract and retain talent in the field of cancer immunotherapy.

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Iovance Biotherapeutics (NASDAQ: IOVA) announced the appointment of Dr. Raj K. Puri as Executive VP of Regulatory Strategy and Translational Medicine, effective Q1 2022. Dr. Puri brings over 33 years of FDA experience, notably leading the Division of Cellular and Gene Therapies. His expertise includes evaluating advanced therapies like T cell immunotherapy and cancer vaccines. Interim CEO Frederick G. Vogt expressed excitement about Dr. Puri's role in enhancing clinical and preclinical programs, contributing significantly to Iovance's mission of improving patient care through accessible T cell-based therapies.

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Iovance Biotherapeutics announced successful manufacturing of tumor-infiltrating lymphocyte (TIL) therapy from cryopreserved tumor samples shipped from Australia. This innovation may address shipment challenges and enhance global access to TIL therapy. The company will present findings at the upcoming Tandem Meetings from February 2-6, 2022, in Salt Lake City, Utah. Two key abstracts will be presented, including results on ex vivo expansion of TILs and their treatment with decitabine. Iovance aims to lead in developing TIL therapies for cancer, particularly lifileucel for metastatic melanoma.

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Iovance Biotherapeutics (NASDAQ: IOVA) announced that Fred Vogt, Interim CEO, will present at the 40th Annual J.P. Morgan Healthcare Conference on January 12, 2022, at 7:30 a.m. ET. The event will feature a live and archived webcast available on their website. Iovance is focused on developing T cell-based immunotherapies, with a lead candidate, lifileucel, showing promise for treating metastatic melanoma. The company emphasizes innovation in cell therapy aimed at improving cancer care.

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Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) granted inducement stock options for 107,900 shares to eleven new non-executive employees on December 16, 2021. This grant is part of Iovance's 2021 Inducement Plan and complies with Nasdaq Listing Rule 5635(c)(4). The stock options have an exercise price of $17.80, equivalent to the closing price on the grant date. Each option vests over three years, with one-third vesting after one year and the rest quarterly thereafter, contingent on continued employment.

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Iovance Biotherapeutics (NASDAQ: IOVA) recently announced its participation in key December conferences focused on cancer immunotherapy. The company will engage in a fireside chat at the JMP Securities Hematology and Oncology Summit on December 7 at 1:40 p.m. ET. Additionally, Iovance will present an on-demand poster at the ESMO Immuno-Oncology Annual Meeting from December 8-11, highlighting AKT inhibition's impact on TIL expansion. At the American Society of Hematology Annual Meeting from December 11-14, a poster will detail the Phase 1/2 study of IOV-2001 for chronic lymphocytic leukemia.

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Iovance Biotherapeutics (NASDAQ: IOVA) announced the grant of inducement stock options for 168,575 shares to seven new non-executive employees on November 18, 2021. The options, part of the 2021 Inducement Plan, have an exercise price of $19.05, equal to the closing stock price on the grant date. Each option vests over three years, with one-third vesting on the first anniversary and the remainder in quarterly installments. This move is aligned with Iovance's focus on developing T cell-based cancer immunotherapies, notably its lead candidate lifileucel for metastatic melanoma.

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Iovance Biotherapeutics (NASDAQ: IOVA) reported promising clinical data on its lifileucel TIL cell therapy combined with pembrolizumab, presented at the SITC Annual Meeting. The overall response rates were 57.1% in cervical cancer, 60.0% in melanoma, and 38.9% in head and neck cancer. Notably, a 30% complete response rate was observed in melanoma patients. The findings support continued investigation of TIL therapy as a treatment option. A conference call is scheduled for November 13, 2021, to discuss these results further.

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Iovance Biotherapeutics has announced new clinical data for its TIL therapy, LN-145, showcasing a 21.4% overall response rate in heavily pre-treated patients with metastatic non-small cell lung cancer (mNSCLC). The therapy demonstrated effectiveness even in patients resistant to previous treatments. The clinical trial results were presented during the SITC Annual Meeting in Washington, D.C. and suggest continued investigation of LN-145 in upcoming studies. The company emphasizes the significance of these findings in addressing unmet needs in second-line mNSCLC treatment.

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FAQ

What is the current stock price of Iovance Biotherapeutics (IOVA)?

The current stock price of Iovance Biotherapeutics (IOVA) is $8.55 as of November 22, 2024.

What is the market cap of Iovance Biotherapeutics (IOVA)?

The market cap of Iovance Biotherapeutics (IOVA) is approximately 2.6B.

What does Iovance Biotherapeutics specialize in?

Iovance Biotherapeutics specializes in developing tumor-infiltrating lymphocyte (TIL) therapies, which are a form of autologous T-cell therapy aimed at treating solid tumors.

What is lifileucel, marketed as AMTAGVI™?

Lifileucel, marketed as AMTAGVI™, is an autologous T-cell therapy that has recently gained FDA approval for treating advanced melanoma.

What recent regulatory challenges has Iovance faced?

The FDA placed a clinical hold on the IOV-LUN-202 trial due to a fatal adverse event. However, this hold does not affect other Iovance trials or the FDA’s priority review of lifileucel in advanced melanoma.

Who are Iovance's key manufacturing partners?

Iovance partners with WuXi Advanced Therapies for the manufacturing and analytical testing of AMTAGVI. They also have their own Iovance Cell Therapy Center (iCTC) in Philadelphia.

What are the financial highlights for Iovance in Q1 2024?

Iovance reported a net loss of $113.0 million for Q1 2024, with revenue from Proleukin® sales contributing $0.7 million. The company continues to invest heavily in research, development, and commercialization efforts.

Which cancers are Iovance's TIL therapies being tested for?

Besides metastatic melanoma, Iovance’s TIL therapies are being tested for head and neck carcinoma, cervical cancer, non-small cell lung cancer, and potentially other tumor types like ovarian, breast, bladder, and colorectal cancer.

How does Iovance's TIL therapy work?

Iovance's TIL therapy involves harvesting and expanding a patient’s own tumor-infiltrating lymphocytes in a lab, then reinfusing billions of these cells to fight cancer.

What is the significance of the FDA approval of AMTAGVI™?

The FDA approval of AMTAGVI™ is significant as it marks the first T-cell therapy for a solid tumor, providing a new treatment option for patients with advanced melanoma.

What future plans does Iovance have for lifileucel?

Iovance plans to expand the use of lifileucel into other cancer indications and is currently conducting the TILVANCE-301 Phase 3 trial to support further regulatory approvals and broader market access.

Where can I find more information about Iovance Biotherapeutics?

More information about Iovance Biotherapeutics can be found on their official website at www.iovance.com.

Iovance Biotherapeutics, Inc.

Nasdaq:IOVA

IOVA Rankings

IOVA Stock Data

2.58B
276.51M
0.53%
88.05%
19.61%
Biotechnology
Biological Products, (no Disgnostic Substances)
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United States of America
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