Iovance Biotherapeutics Poised for Growth with New Approvals
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 1 hour ago
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Should l Buy IOVA?
Source: Fool
- Product Approval Milestone: Iovance Biotherapeutics achieved a significant milestone two years ago by securing approval for its first product, lifileucel, commercialized as Amtagvi for melanoma that cannot be completely surgically removed, showcasing the strength of the company's technology.
- Revenue Growth Momentum: Although Iovance is not yet profitable, it reported a 13% increase in revenue to $68 million in the latest quarter, indicating that Amtagvi is beginning to generate substantial income and enhancing its market competitiveness.
- Strong Clinical Performance: A recent study revealed that Amtagvi achieved a 52% objective response rate in real-world conditions, significantly higher than the 31% observed in the clinical trial that supported its accelerated approval, which should encourage more physicians to consider this treatment for their patients.
- Future Development Potential: Iovance is studying lifileucel across various cancers, with many trials in phase 2, suggesting that new indications for the candidate may be on the horizon, further propelling the company's stock price upward.
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Analyst Views on IOVA
Wall Street analysts forecast IOVA stock price to rise
8 Analyst Rating
6 Buy
1 Hold
1 Sell
Moderate Buy
Current: 2.850
Low
1.50
Averages
9.50
High
17.00
Current: 2.850
Low
1.50
Averages
9.50
High
17.00
About IOVA
Iovance Biotherapeutics, Inc. is a commercial biotechnology company. It is focused on developing and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer. Its product, Amtagvi, is a tumor-derived autologous T cell immunotherapy indicated for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor. It is marketing Proleukin (aldesleukin), an interleukin-2 (IL-2) product used in the Amtagvi treatment regimen and in other applications. Amtagvi and Proleukin are part of a treatment regimen that includes lymphodepletion. Its development pipeline includes multicenter trials of TIL cell therapies in additional treatment settings and indications for solid tumor cancers. It also develops therapies, such as genetically modified TIL cell therapy and cytokines for use in the TIL cell therapy regimen.
About the author

Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
- Product Approval and Revenue Growth: Iovance Biotherapeutics received approval for its first product, lifileucel, two years ago, commercialized as Amtagvi for melanoma that cannot be completely removed by surgery, with a recent quarter revenue growth of 13% to $68 million, indicating strong market potential.
- Outstanding Clinical Performance: In real-world conditions, Amtagvi achieved a 52% objective response rate, significantly higher than the 31% from the clinical trial that supported its accelerated approval, encouraging more doctors to consider this treatment for their patients and driving further sales growth.
- Multiple Indication Research: Iovance is studying lifileucel across various cancers, with many trials in phase 2, suggesting that new indications for the candidate may not be far off, enhancing market confidence in its future growth.
- Investment Opportunity and Market Potential: Currently, Iovance shares are priced under $3, making it accessible to many investors, and if its pipeline succeeds, the stock could see significant appreciation, although the analyst team did not include it in their top investment stocks, the market remains optimistic about its potential.
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- Product Approval Milestone: Iovance Biotherapeutics achieved a significant milestone two years ago by securing approval for its first product, lifileucel, commercialized as Amtagvi for melanoma that cannot be completely surgically removed, showcasing the strength of the company's technology.
- Revenue Growth Momentum: Although Iovance is not yet profitable, it reported a 13% increase in revenue to $68 million in the latest quarter, indicating that Amtagvi is beginning to generate substantial income and enhancing its market competitiveness.
- Strong Clinical Performance: A recent study revealed that Amtagvi achieved a 52% objective response rate in real-world conditions, significantly higher than the 31% observed in the clinical trial that supported its accelerated approval, which should encourage more physicians to consider this treatment for their patients.
- Future Development Potential: Iovance is studying lifileucel across various cancers, with many trials in phase 2, suggesting that new indications for the candidate may be on the horizon, further propelling the company's stock price upward.
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- Stock Option Grant: On February 19, 2026, Iovance Biotherapeutics approved the grant of 3,600 stock options to two new non-executive employees, aimed at attracting and retaining talent, thereby enhancing the company's competitive edge in tumor immunotherapy.
- Exercise Price Setting: Each stock option has an exercise price of $2.85, equal to the closing price of Iovance's common stock on the grant date, which helps align employee incentives with company performance and promotes long-term growth.
- Vesting Arrangement: The stock options will vest over three years, with one-third vesting on the first anniversary and the remaining shares vesting in quarterly installments over the next two years, ensuring ongoing employee engagement and contribution.
- Strategic Implications: This stock option grant aligns with Iovance's long-term strategic goals, aiming to drive the development of tumor-infiltrating lymphocyte therapies through continuous innovation and talent acquisition, further solidifying its leadership position in the biotechnology sector.
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- Significant Clinical Efficacy: Iovance Biotherapeutics reported that commercial Amtagvi® achieved a 44% objective response rate (ORR) and a 73% disease control rate in 41 previously treated advanced melanoma patients, showcasing its outstanding performance in real-world settings and potentially transforming the treatment landscape for advanced melanoma.
- Early Treatment Advantage: The data revealed that patients receiving two or fewer lines of therapy had an ORR of 52%, compared to only 33% for those with three or more lines, indicating that early administration of Amtagvi significantly enhances patient response, underscoring the importance of timely intervention.
- FDA Accelerated Approval Context: Amtagvi received FDA accelerated approval in February 2024 based on the ORR and duration of response (DOR) from the C-144-01 clinical trial, with the new real-world data showing an ORR of 31%, highlighting the clinical relevance of these findings and potentially driving broader clinical adoption.
- Market Demand and Outlook: With over 8,000 annual deaths from advanced melanoma in the U.S. and more than half of patients progressing within 12 months of standard care, the successful application of Amtagvi not only addresses an unmet medical need but also presents significant market opportunities for Iovance.
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- Retail Sentiment Remains Bullish: Over the past 24 hours, retail sentiment around Iovance (IOVA) stock on Stocktwits has stayed in the ‘bullish’ territory, with message volume at ‘high’ levels, indicating strong investor confidence in the company's future developments.
- Significant Revenue Growth: For the three months ending September, Iovance reported total product revenue of $68 million, including $58 million from Amtagvi sales in the U.S., highlighting the company's robust performance in the tumor immunotherapy market.
- Optimistic 2025 Revenue Outlook: Iovance expects full-year 2025 revenue to range between $250 million and $300 million, marking the first full calendar year of Amtagvi sales, with analysts forecasting an average revenue of $259.45 million, reflecting market anticipation for its products.
- Stock Price Volatility and Acquisition Rumors: Despite an 8% rise in IOVA shares on Monday, the stock has fallen 54% over the past 12 months, with investors expressing concern over management's potential discussions with Merck, which could impact future acquisition opportunities.
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- Stock Option Grant: On January 15, 2026, Iovance Biotherapeutics approved the grant of a total of 97,710 stock options to 17 new non-executive employees, aimed at attracting and retaining talent, thereby enhancing the company's competitiveness in the tumor immunotherapy sector.
- Exercise Price Setting: Each stock option has an exercise price of $2.22, which matches the closing price of Iovance's common stock on the grant date, a pricing strategy that helps incentivize employees to grow alongside the company and enhances their sense of belonging.
- Vesting Schedule: The stock options will vest over three years, with one-third vesting on the first anniversary of the employee's start date and the remaining shares vesting in quarterly installments over the next two years, ensuring long-term employee commitment aligns with the company's growth.
- Incentive Plan Background: This grant is made under Iovance's inducement plan established in 2021 and amended multiple times, complying with Nasdaq listing rules, reflecting the company's commitment to talent acquisition and its ongoing strategic development in the biotechnology industry.
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