Iovance Biotherp Stock Price, News & Analysis

Iovance Biotherapeutics (NASDAQ: IOVA) has achieved a significant milestone as Health Canada approved Amtagvi® (lifileucel) for treating advanced melanoma. This marks the first T cell therapy approved for solid tumor cancer in Canada and the company's first marketing authorization outside the U.S.

Amtagvi is specifically indicated for adult patients with unresectable or metastatic melanoma who have progressed after prior systemic therapy, including PD-1 blocking antibody and BRAF/MEK inhibitors where applicable. The approval was granted under Notice of Compliance with Conditions (NOC/c) based on the global C-144-01 trial results, pending confirmation of clinical benefits.

The company plans to authorize its first Canadian treatment center within the next few months and is pursuing expansion into additional markets.

Iovance Biotherapeutics (NASDAQ: IOVA) reported strong Q2 2025 financial results, with total product revenue of $60.0M, a 93% year-over-year increase. The company's flagship product Amtagvi generated $54.1M in revenue, with over 100 patients treated in Q2. The company reiterated its FY25 total product revenue guidance of $250M-$300M.

Key developments include a strategic restructuring expected to save over $100M annually and extend cash runway into Q4 2026, a real-world study showing 48.8% objective response rate for Amtagvi, and expansion of treatment centers to 80+ U.S. locations across 35 states. The company maintains a strong cash position of $307.1M as of June 30, 2025.

Pipeline progress includes ongoing trials in melanoma, NSCLC, and endometrial cancer, with several regulatory milestones expected in key markets including Canada, UK, and Australia.

Iovance Biotherapeutics (NASDAQ: IOVA), a biotechnology company specializing in tumor infiltrating lymphocyte (TIL) therapies for cancer treatment, has scheduled its second quarter and first half 2025 financial results announcement for August 7, 2025.

The company will host a conference call and webcast at 4:30 p.m. ET to discuss financial performance and provide corporate updates. Investors can access the webcast through the company's website at IR.Iovance.com, with the recording remaining available for one year.

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Iovance Biotherapeutics (NASDAQ: IOVA), a biotechnology company specializing in TIL cancer therapies, has announced the approval of inducement stock options for new employees. The company granted options for 138,190 shares to 20 new, non-executive employees on July 17, 2025.

The stock options, issued under Iovance's Amended and Restated 2021 Inducement Plan, have an exercise price of $2.34 per share. The options will vest over three years, with one-third vesting after the first year and the remaining portions vesting quarterly over the following two years, contingent on continued employment.

Iovance Biotherapeutics (NASDAQ: IOVA), a commercial biotechnology company specializing in TIL therapies for cancer patients, has appointed Corleen Roche as Chief Financial Officer, effective August 6th, 2025.

Roche brings 30 years of experience in biotech and life sciences, having previously served as CFO at CG Oncology and held executive financial roles at Immunome, Biogen, CSL Behring, Sandoz, Wyeth, and Pfizer. Her track record includes successful commercial launches of notable products like ZARXIO®, GLATOPA™, and PREVNAR 13®.

The appointment comes at a crucial time during Iovance's first commercial launch, with focus on revenue growth and pipeline investment optimization.

Iovance Biotherapeutics (NASDAQ: IOVA) reported positive real-world data for its commercial Amtagvi® (lifileucel) therapy in advanced melanoma patients. The study showed a 48.8% overall response rate among 41 evaluable patients across four treatment centers. Notably, patients receiving treatment in third-line or earlier demonstrated a higher response rate of 60.9%, while those with three or more prior lines of therapy showed a 33.3% response rate.

Amtagvi, approved by the FDA in February 2024, is the first one-time T cell therapy for solid tumor cancer and the first approved treatment for advanced melanoma after anti-PD-1 and targeted therapy. The company is currently conducting the TILVANCE-301 Phase 3 trial in frontline advanced melanoma to confirm clinical benefit.

Iovance Biotherapeutics (NASDAQ: IOVA), a commercial biotechnology company specializing in tumor infiltrating lymphocyte (TIL) therapies, has appointed Dr. Marc R. Theoret as Senior Vice President, Regulatory Strategy. Dr. Theoret brings over 15 years of FDA experience, most recently serving as Deputy Center Director of the Oncology Center of Excellence (OCE).

In his new role, Dr. Theoret will focus on clinical regulatory strategy for Iovance's pipeline, reporting to Chief Regulatory Officer Dr. Raj K. Puri. His extensive background includes leading regulatory reviews of drugs and biologics for various cancers and contributing to numerous oncology application approvals. He also has practical experience in conducting adoptive cellular therapy trials at the National Cancer Institute.

Iovance Biotherapeutics (NASDAQ: IOVA), a biotechnology company specializing in novel polyclonal tumor infiltrating lymphocyte (TIL) therapies, has announced the approval of inducement stock options for new employees. The company granted options for 312,660 shares to 58 new, non-executive employees on June 20, 2025.

The stock options, issued under Iovance's Amended and Restated 2021 Inducement Plan, have an exercise price of $1.98 per share. The options will vest over three years, with one-third vesting after the first year and the remaining portions vesting quarterly over the following two years, contingent on continued employment.

Iovance Biotherapeutics (NASDAQ: IOVA), a biotech company specializing in tumor infiltrating lymphocyte (TIL) therapies for cancer treatment, announced its participation in the Goldman Sachs Global Healthcare Conference. The company's senior leadership will engage in a fireside chat on June 11, 2025, at 1:20 p.m. ET in Miami, FL. Investors and interested parties can access both live and archived webcasts of the presentation through the company's investor relations website at ir.iovance.com.