July 17, 2026 17:15 ET | Source: Iovance Biotherapeutics, Inc.
SAN CARLOS, Calif., July 17, 2026 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) ("Iovance" or the “Company”), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (“TIL”) therapies for patients with cancer, today announced that on July 16, 2026 (the “Date of Grant”), the Company approved the grant of inducement stock options covering an aggregate of 139,930 shares of Iovance’s common stock to seventeen new, non-executive employees.
The awards were granted under Iovance’s Amended and Restated 2021 Inducement Plan, which provides for the granting of equity awards to new employees of Iovance by the Company’s compensation committee in accordance with Nasdaq Listing Rule 5635(c)(4). Each of the stock options granted as referenced in this press release has an exercise price of $4.66, the closing price of Iovance’s common stock on the Date of Grant. Each stock option vests over a three-year period, with one-third of the shares vesting on the first anniversary of the employee’s start date (the “First Vesting Date”) and the remaining shares vesting in eight quarterly installments over the next two years, commencing with the first quarter following the First Vesting Date, subject to continued employment with the Company through the applicable vesting dates.
About Iovance Biotherapeutics, Inc.
Iovance Biotherapeutics, Inc. aims to be the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (“TIL”) therapies for patients with cancer. We are pioneering a transformational approach to cure cancer by harnessing the human immune system’s ability to recognize and destroy diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. Iovance’s Amtagvi® is the first FDA-approved T cell therapy for a solid tumor indication. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, that may extend and improve life for patients with cancer. For more information, please visit www.iovance.com.
Amtagvi® and its accompanying design marks, Proleukin®, Iovance®, and IovanceCares™ are trademarks and registered trademarks of Iovance Biotherapeutics, Inc. or its subsidiaries. All other trademarks and registered trademarks are the property of their respective owners.
Forward-Looking Statements
Certain matters discussed in this press release are “forward-looking statements” of Iovance Biotherapeutics, Inc. (hereinafter referred to as the “Company,” “we,” “us,” or “our”) within the meaning of the Private Securities Litigation Reform Act of 1995 (the “PSLRA”). Without limiting the foregoing, we may, in some cases, use terms such as “predicts,” “believes,” “potential,” “achievable,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “forecast,” “guidance,” “outlook,” “may,” “can,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes and are intended to identify forward-looking statements. Forward-looking statements are based on assumptions and assessments made in light of management’s experience and perception of historical trends, current conditions, expected future developments, and other factors believed to be appropriate. Forward-looking statements in this press release are made as of the date of this press release, and we undertake no duty to update or revise any such statements, whether as a result of new information, future events or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties, and other factors, many of which are outside of our control, that may cause actual results, levels of activity, performance, achievements, and developments to be materially different from those expressed in or implied by these forward-looking statements. Important factors that could cause actual results, developments, and business decisions to differ materially from forward-looking statements are described in the sections titled "Risk Factors" in our filings with the U.S. Securities and Exchange Commission, including our most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q.
Analyst’s Disclosure: I/we have no stock, option or similar derivative position in any of the companies mentioned, and no plans to initiate any such positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.
This article is intended to provide informational content and should not be viewed as an exhaustive analysis of the featured company. It should not be interpreted as personalized investment advice with regard to "Buy/Sell/Hold/Short/Long" recommendations. Financial models presented here, including DCF, rNPV, and scenario analyses, are illustrative tools based on the author's assumptions and are highly sensitive to inputs; small changes can materially alter outputs. The predictions and opinions presented reflect a probabilistic approach, not absolute certainty. Efforts have been made to ensure accuracy, but inadvertent errors may occur. Readers are advised to independently verify information and conduct their own research. Investing in stocks involves inherent volatility and risk. Before making any investment decisions, it is crucial for readers to conduct thorough research and assess their financial circumstances. The author is not liable for any financial losses incurred as a result of using or relying on the content of this article.
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After several years of underperforming the market, Iovance Biotherapeutics (IOVA 1.61%) is finally bouncing back. The biotech company's shares have soared 74% this year. However, the stock still looks pretty cheap -- it is trading for just under $5 apiece. And for what it's worth, several Wall Street analysts think it could rise even more. Its average price target (according to Yahoo! Finance) is $8.80. Should investors rush to buy the company's shares?
Image source: The Motley Fool.
A high-risk, high-reward play Iovance Biotherapeutics developed Amtagvi, an approved medicine for treating melanoma. Amtagvi is manufactured from patients' own cancer-fighting cells, which are harvested, grown in a lab, and then reinserted back into the patient. Amtagvi's sales are growing at a good clip. In the first quarter, Iovance Biotherapeutics' revenue (mostly from this product) increased 45% year over year to $71.4 million. Meanwhile, Iovance Biotherapeutics is making progress in regions outside the U.S. It earned approval for Amtagvi in Canada last year, and could see the medicine's sales improve meaningfully as it ramps up commercial efforts in the country.
Further, Iovance Biotherapeutics could obtain approval for Amtagvi in several other countries, including across the European Union. Launching the medicine in these regions would significantly expand its addressable opportunity, likely even more so than the Canadian market. Elsewhere, the company is making clinical progress. Iovance Biotherapeutics is developing Amtagvi for the treatment of endometrial cancer. The company also boasts several other pipeline candidates. Provided the biotech company can earn significant clinical wins over the next few years while also making solid commercial progress with Amtagvi, it could maintain the momentum it has had so far this year.
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However, several factors could derail Iovance Biotherapeutics' plans, including the very real risk of clinical or regulatory setbacks every drugmaker faces. It has already encountered several. For instance, Iovance Biotherapeutics announced earlier this year that it was withdrawing its regulatory application for Amtagvi in the United Kingdom due to "procedural reasons," although it said it would resubmit it promptly. Beyond potential regulatory roadblocks, there is a much bigger issue with the Company. The medicines it develops are complex to manufacture and administer.
It takes about a month for Amtagvi to be manufactured after patients' cells have been harvested. And before receiving treatment, they have to undergo chemotherapy. Can Iovance Biotherapeutics eventually turn a profit, given that its therapies are so complex and expensive to administer? It's not clear that it can, and the company's bull case depends on a lot of things going right. Iovance Biotherapeutics may maintain its momentum if it continues to post strong financial results while eventually earning new approvals and label expansions. But the company is trading at a low price for a reason, and it could fall much further if it faces headwinds. So, Iovance Biotherapeutics is fairly risky, and only investors comfortable with volatility should consider initiating a position.
Healthcare is changing through AI and personalized cell therapy. Which of these high-growth innovators represents the better risk-adjusted opportunity for your portfolio today as you evaluate Heartflow Inc. (HTFL 9.05%) and Iovance Biotherapeutics (IOVA +8.56%)?
Heartflow focuses on non-invasive AI diagnostics for heart disease, while Iovance develops personalized cell therapies to treat solid tumors. Both companies are scaling commercial operations in high-stakes medical fields, offering investors exposure to cutting-edge clinical technology. This comparison evaluates their financial health and market risks to determine which aligns best with your investment strategy.
The case for Heartflow Inc.Heartflow sells AI-enabled software designed to analyze coronary artery disease. The company provides these tools to clinicians to help identify blockages more accurately than traditional tests. Heartflow currently maintains about 1,465 accounts in the U.S. and is expanding its reach among healthcare stocks by focusing on its core FFR CT Analysis product, which generates nearly 98% of its revenue.
In FY 2025, revenue reached about $176 million, a 40% increase over the prior year. Despite this strong top-line expansion, the business reported a net loss of $116.8 million for the period.
As of its December 2025 balance sheet, the debt-to-equity ratio is approximately 0.1x. This ratio compares total debt to shareholders’ equity, indicating a low level of borrowing relative to shareholders’ equity. Free cash flow, calculated as cash from operations minus capital expenditures, was nearly negative $59.0 million for the year.
Iovance Biotherapeutics develops personalized tumor-infiltrating lymphocyte therapies to treat patients with cancer. The company generates revenue by selling its primary products, Amtagvi and Proleukin, to hospitals, clinics, and specialized distributors. To support its pipeline, Iovance maintains critical license agreements with major organizations, including Novartis AG (NVS +3.74%) and Cellectis SA (CLLS +12.24%), while operating its own centralized manufacturing facility.
During FY 2025, the company reported revenue of $263.5 million, reflecting a significant 60.6% growth rate over the prior year. This increase followed the successful commercial scaling of its lead therapies across North American markets. However, the company recorded a net loss of roughly $391 million, slightly deeper than 2024.
According to its December 2025 balance sheet, Iovance maintains a debt-to-equity ratio of approximately 0.1x. Free cash flow for fiscal year 2025 was negative $336.2 million, reflecting the heavy capital requirements of personalized cell therapy manufacturing and clinical trials.
Risk profile comparisonHeartflow relies on a single product for 98% of its revenue, creating significant concentration risk. The company is also cooperating with a U.S. Department of Justice investigation regarding its marketing activities and financial arrangements with providers. Furthermore, the proposed 2026 Medicare rules suggest a 15% reduction in reimbursement for its core service, while competition remains intense from GE HealthCare Technologies Inc (GEHC +1.15%), Siemens, and Philips (PHG +1.98%).
Iovance faces substantial financial risk with an accumulated deficit of $2.9 billion as of March 31, 2026. The manufacturing process for its therapies is highly complex and patient-specific, which poses risks of contamination or supply chain failure. Additionally, the company is managing the aftermath of a 19% workforce reduction intended to extend its cash runway, which may impact its long-term operational capacity and growth initiatives.
Valuation comparisonNeither company is seen making a profit in 2026, so neither has a forward price-to-earnings ratio.
MetricHeartflow Inc. Common StockIovance BiotherapeuticsSector BenchmarkForward P/En/an/a389.1xP/S ratio13.8x5.3xSector benchmark uses the SPDR XLV sector ETF.
Valuation metrics sourced from Financial Modeling Prep (FMP) and may differ from other data providers.
Which stock would I buy in 2026?Heartflow is in the early stages of its commercialization. Heartflow’s use of AI to assist doctors in detecting heart blood flow blockages non-invasively is real-world proof of AI’s ability to improve patients’ lives. The company boasts the largest proprietary set of medical images on which to base its forthcoming autonomous diagnostic tool. Heartflow says it has 200 million doctor-annotated images to teach its AI. It, however, isn’t expected to generate positive free cash flow until 2028.
Iovance saw first-quarter 2026 revenue rise 45% year over year to 71.4 million, and management expects second-quarter sales to be up about 23% from the same period in 2025. It, too, is expected to turn cash flow positive in 2028. Over time, it expects total sales of Amtagvi and Proleuken to each surpass $1 billion, making them both blockbusters in pharma investor parlance.
Each business is exciting in its own way. Iovance Biotherapeutics gets the nod over Heartflow by virtue of its lower price-to-sales ratio under the guide of buy good companies at good prices.
June 19, 2026 17:15 ET | Source: Iovance Biotherapeutics, Inc.
SAN CARLOS, Calif., June 19, 2026 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) ("Iovance" or the “Company”), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (“TIL”) therapies for patients with cancer, today announced that on June 18, 2026 (the “Date of Grant”), the Company approved the grant of inducement stock options covering an aggregate of 140,860 shares of Iovance’s common stock to twenty-seven new, non-executive employees.
The awards were granted under Iovance’s Amended and Restated 2021 Inducement Plan, which provides for the granting of equity awards to new employees of Iovance by the Company’s compensation committee in accordance with Nasdaq Listing Rule 5635(c)(4). Each of the stock options granted as referenced in this press release has an exercise price of $3.91, the closing price of Iovance’s common stock on the Date of Grant. Each stock option vests over a three-year period, with one-third of the shares vesting on the first anniversary of the employee’s start date (the “First Vesting Date”) and the remaining shares vesting in eight quarterly installments over the next two years, commencing with the first quarter following the First Vesting Date, subject to continued employment with the Company through the applicable vesting dates.
About Iovance Biotherapeutics, Inc.
Iovance Biotherapeutics, Inc. aims to be the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (“TIL”) therapies for patients with cancer. We are pioneering a transformational approach to cure cancer by harnessing the human immune system’s ability to recognize and destroy diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. Iovance’s Amtagvi® is the first FDA-approved T cell therapy for a solid tumor indication. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, that may extend and improve life for patients with cancer. For more information, please visit www.iovance.com.
Amtagvi® and its accompanying design marks, Proleukin®, Iovance®, and IovanceCares™ are trademarks and registered trademarks of Iovance Biotherapeutics, Inc. or its subsidiaries. All other trademarks and registered trademarks are the property of their respective owners.
Forward-Looking Statements
Certain matters discussed in this press release are “forward-looking statements” of Iovance Biotherapeutics, Inc. (hereinafter referred to as the “Company,” “we,” “us,” or “our”) within the meaning of the Private Securities Litigation Reform Act of 1995 (the “PSLRA”). Without limiting the foregoing, we may, in some cases, use terms such as “predicts,” “believes,” “potential,” “achievable,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “forecast,” “guidance,” “outlook,” “may,” “can,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes and are intended to identify forward-looking statements. Forward-looking statements are based on assumptions and assessments made in light of management’s experience and perception of historical trends, current conditions, expected future developments, and other factors believed to be appropriate. Forward-looking statements in this press release are made as of the date of this press release, and we undertake no duty to update or revise any such statements, whether as a result of new information, future events or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties, and other factors, many of which are outside of our control, that may cause actual results, levels of activity, performance, achievements, and developments to be materially different from those expressed in or implied by these forward-looking statements. Important factors that could cause actual results, developments, and business decisions to differ materially from forward-looking statements are described in the sections titled "Risk Factors" in our filings with the U.S. Securities and Exchange Commission, including our most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q.
IOVA guides for $350M–$370M 2026 revenue (36% YoY growth), with Q2'26 expected to be a record Amtagvi quarter. Expansion into new indications (NSCLC, endometrial, sarcoma) and global markets underpins the pipeline-in-a-drug thesis. A more receptive FDA increases the likelihood of accelerated approvals based on single-arm data, streamlining IOVA's development path.
April 17, 2026 17:15 ET | Source: Iovance Biotherapeutics, Inc.
SAN CARLOS, Calif., April 17, 2026 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) ("Iovance" or the “Company”), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (“TIL”) therapies for patients with cancer, today announced that on April 16, 2026 (the “Date of Grant”), the Company approved the grant of inducement stock options covering an aggregate of 135,470 shares of Iovance’s common stock to twelve new, non-executive employees.
The awards were granted under Iovance’s Amended and Restated 2021 Inducement Plan, which was adopted on September 22, 2021 and amended and restated on January 12, 2022, March 13, 2023, February 26, 2024, and November 22, 2024, and provides for the granting of equity awards to new employees of Iovance by the Company’s compensation committee in accordance with Nasdaq Listing Rule 5635(c)(4). Each of the stock options granted as referenced in this press release has an exercise price of $3.80, the closing price of Iovance’s common stock on the Date of Grant. Each stock option vests over a three-year period, with one-third of the shares vesting on the first anniversary of the employee’s start date (the “First Vesting Date”) and the remaining shares vesting in eight quarterly installments over the next two years, commencing with the first quarter following the First Vesting Date, subject to continued employment with the Company through the applicable vesting dates.
About Iovance Biotherapeutics, Inc.
Iovance Biotherapeutics, Inc. aims to be the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (“TIL”) therapies for patients with cancer. We are pioneering a transformational approach to cure cancer by harnessing the human immune system’s ability to recognize and destroy diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. Iovance’s Amtagvi® is the first FDA-approved T cell therapy for a solid tumor indication. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, that may extend and improve life for patients with cancer. For more information, please visit www.iovance.com.
Amtagvi® and its accompanying design marks, Proleukin®, Iovance®, and IovanceCares™ are trademarks and registered trademarks of Iovance Biotherapeutics, Inc. or its subsidiaries. All other trademarks and registered trademarks are the property of their respective owners.
Forward-Looking Statements
Certain matters discussed in this press release are “forward-looking statements” of Iovance Biotherapeutics, Inc. (hereinafter referred to as the “Company,” “we,” “us,” or “our”) within the meaning of the Private Securities Litigation Reform Act of 1995 (the “PSLRA”). Without limiting the foregoing, we may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “forecast,” “guidance,” “outlook,” “may,” “can,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes and are intended to identify forward-looking statements. Forward-looking statements are based on assumptions and assessments made in light of management’s experience and perception of historical trends, current conditions, expected future developments, and other factors believed to be appropriate. Forward-looking statements in this press release are made as of the date of this press release, and we undertake no duty to update or revise any such statements, whether as a result of new information, future events or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties, and other factors, many of which are outside of our control, that may cause actual results, levels of activity, performance, achievements, and developments to be materially different from those expressed in or implied by these forward-looking statements. Important factors that could cause actual results, developments, and business decisions to differ materially from forward-looking statements are described in the sections titled "Risk Factors" in our filings with the U.S. Securities and Exchange Commission, including our most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q.
SAN CARLOS, Calif., April 27, 2026 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, will host a conference call and live audio webcast on Thursday, May 7, 2026 at 8:30 a.m. ET to report its first quarter 2026 financial results and corporate updates.
Iovance Biotherapeutics is rated a BUY following Replimune's exit, solidifying IOVA's lead in post-PD-1 melanoma. IOVA's lifileucel shows best-in-class ORR in earlier-line melanoma and promising efficacy in NSCLC, with a strong clinical pipeline and upcoming catalysts. Commercial ramp of lifileucel is underway, with 2025 sales at $220M and gross margins improving to 50%, but operational and adoption hurdles persist.
Iovance Biotherapeutics (IOVA - Free Report) is expected to deliver a year-over-year increase in earnings on higher revenues when it reports results for the quarter ended March 2026. This widely-known consensus outlook gives a good sense of the company's earnings picture, but how the actual results compare to these estimates is a powerful factor that could impact its near-term stock price.
The earnings report, which is expected to be released on May 7, might help the stock move higher if these key numbers are better than expectations. On the other hand, if they miss, the stock may move lower.
While management's discussion of business conditions on the earnings call will mostly determine the sustainability of the immediate price change and future earnings expectations, it's worth having a handicapping insight into the odds of a positive EPS surprise.
Zacks Consensus EstimateThis biotechnology company is expected to post quarterly loss of $0.19 per share in its upcoming report, which represents a year-over-year change of +47.2%.
Revenues are expected to be $77.11 million, up 56.4% from the year-ago quarter.
Estimate Revisions TrendThe consensus EPS estimate for the quarter has been revised 18.18% lower over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period.
Investors should keep in mind that the direction of estimate revisions by each of the covering analysts may not always get reflected in the aggregate change.
Price, Consensus and EPS Surprise
Earnings WhisperEstimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. This insight is at the core of our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction).
The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier.
Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only.
A positive Earnings ESP is a strong predictor of an earnings beat, particularly when combined with a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold). Our research shows that stocks with this combination produce a positive surprise nearly 70% of the time, and a solid Zacks Rank actually increases the predictive power of Earnings ESP.
Please note that a negative Earnings ESP reading is not indicative of an earnings miss. Our research shows that it is difficult to predict an earnings beat with any degree of confidence for stocks with negative Earnings ESP readings and/or Zacks Rank of 4 (Sell) or 5 (Strong Sell).
How Have the Numbers Shaped Up for Iovance Biotherapeutics?For Iovance Biotherapeutics, the Most Accurate Estimate is lower than the Zacks Consensus Estimate, suggesting that analysts have recently become bearish on the company's earnings prospects. This has resulted in an Earnings ESP of -10.53%.
On the other hand, the stock currently carries a Zacks Rank of #3.
So, this combination makes it difficult to conclusively predict that Iovance Biotherapeutics will beat the consensus EPS estimate.
Does Earnings Surprise History Hold Any Clue?Analysts often consider to what extent a company has been able to match consensus estimates in the past while calculating their estimates for its future earnings. So, it's worth taking a look at the surprise history for gauging its influence on the upcoming number.
For the last reported quarter, it was expected that Iovance Biotherapeutics would post a loss of$0.22 per share when it actually produced a loss of -$0.18, delivering a surprise of +18.18%.
Over the last four quarters, the company has beaten consensus EPS estimates two times.
Bottom LineAn earnings beat or miss may not be the sole basis for a stock moving higher or lower. Many stocks end up losing ground despite an earnings beat due to other factors that disappoint investors. Similarly, unforeseen catalysts help a number of stocks gain despite an earnings miss.
That said, betting on stocks that are expected to beat earnings expectations does increase the odds of success. This is why it's worth checking a company's Earnings ESP and Zacks Rank ahead of its quarterly release. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported.
Iovance Biotherapeutics doesn't appear a compelling earnings-beat candidate. However, investors should pay attention to other factors too for betting on this stock or staying away from it ahead of its earnings release.
An Industry Player's Expected ResultsAcadia Pharmaceuticals (ACAD - Free Report) , another stock in the Zacks Medical - Biomedical and Genetics industry, is expected to report earnings per share of $0.04 for the quarter ended March 2026. This estimate points to a year-over-year change of -63.6%. Revenues for the quarter are expected to be $281.75 million, up 15.3% from the year-ago quarter.
Over the last 30 days, the consensus EPS estimate for Acadia has been revised 7.9% down to the current level. Nevertheless, the company now has an Earnings ESP of +100.00%, reflecting a higher Most Accurate Estimate.
This Earnings ESP, combined with its Zacks Rank #3 (Hold), suggests that Acadia will most likely beat the consensus EPS estimate. The company beat consensus EPS estimates in each of the trailing four quarters.
Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar.
Iovance Biotherapeutics (IOVA +4.76%) has performed well this year, with its shares up 34% to date as of writing. Zooming out gives a different picture, though. The stock has lost nearly 90% of its value over the past five years. Could Iovance Biotherapeutics sustain the run it has had so far in 2026? Judging by the stock's average price target of $9 (according to Yahoo! Finance) -- implying a potential upside of 165% from its current level -- Wall Street analysts certainly have high hopes for the biotech. Let's find out whether Iovance Biotherapeutics can match The Street's target over the next 12 months.
Image source: The Motley Fool.
Potential catalysts on the horizon Iovance Biotherapeutics focuses on developing cancer medicines. The company's most important product is Amtagvi, which is approved for the treatment of melanoma. Amtagvi is helping Iovance Biotherapeutics post strong top-line growth. In 2025, the company's total revenue was $263.5 million, an increase of almost 61% compared to 2024. Iovance Biotherapeutics is still looking at a vast worldwide opportunity for Amtagvi in melanoma, which causes about 59,000 annual deaths worldwide (including 8,000 in the U.S.).
The medicine earned approval in Canada last year. Iovance Biotherapeutics is looking to launch it in other markets, including Europe and Australia. Considering how quickly the medicine's sales have grown -- mostly due to its progress in the U.S. -- these additional regions could help Amtagvi generate over $1 billion in annual sales within a few years. Further, Iovance Biotherapeutics will seek to expand Amtagvi's indications. The company is targeting lung cancer, which represents a much bigger opportunity than melanoma.
Provided clinical trials for lifileucel (the active ingredient in Amtagvi) go as planned -- and it can secure regulatory approval -- Iovance Biotherapeutics could launch the medicine in lung cancer in 2027.
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Some reasons to worry Iovance Biotherapeutics' performance over the next year will depend on whether it can post strong clinical trial results for lifileucel while expanding Amtagvi's addressable market by entering new regions. The stock could soar if it can execute its strategy with near perfection. But as is usually the case with biotech stocks, the company's shares will fall off a cliff if it fails to reach certain milestones in the next 12 months. There is an additional risk with Iovance Biotherapeutics.
The company develops tumor-infiltrating lymphocyte (TIL) therapies that are manufactured from patients' own cells (which means they can't be manufactured at scale) and are complex to administer. On top of that, they tend to be expensive. Between pushback from third-party payers and some physicians, and the expensive infrastructure required for the commercial rollout of these medicines, Iovance Biotherapeutics faces significant hurdles.
The company will have to address that problem if it ever hopes to turn a profit, and it might take a while to get there. Given all that, my view is that Iovance Biotherapeutics is unlikely to reach $9 in the next year and even less likely to deliver outstanding returns over the medium term.
Prosper Junior Bakiny has no position in any of the stocks mentioned. The Motley Fool has positions in and recommends Iovance Biotherapeutics. The Motley Fool has a disclosure policy.
1Q26 Total Revenue of ~$71M Delivers ~ 45% Year-over-Year Growth 2Q26 Revenue Guidance of $86M to $88M and FY26 of $350M to $370M 40% Confirmed Objective Response Rate in Metastatic Serous Endometrial Cancer SAN CARLOS, Calif., May 07, 2026 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, today reported first quarter 2026 financial results, business achievements, and corporate updates.
Iovance Biotherapeutics (IOVA - Free Report) came out with a quarterly loss of $0.19 per share in line with the Zacks Consensus Estimate. This compares to a loss of $0.36 per share a year ago. These figures are adjusted for non-recurring items.
A quarter ago, it was expected that this biotechnology company would post a loss of $0.22 per share when it actually produced a loss of $0.18, delivering a surprise of +18.18%.
Over the last four quarters, the company has surpassed consensus EPS estimates two times.
Iovance Biotherapeutics, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $71.43 million for the quarter ended March 2026, missing the Zacks Consensus Estimate by 7.36%. This compares to year-ago revenues of $49.32 million. The company has topped consensus revenue estimates just once over the last four quarters.
The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call.
Iovance Biotherapeutics shares have added about 49.8% since the beginning of the year versus the S&P 500's gain of 7.6%.
What's Next for Iovance Biotherapeutics?While Iovance Biotherapeutics has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock?
There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately.
Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions.
Ahead of this earnings release, the estimate revisions trend for Iovance Biotherapeutics was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.
It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is -$0.20 on $88.87 million in revenues for the coming quarter and -$0.61 on $369.36 million in revenues for the current fiscal year.
Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the bottom 40% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1.
Another stock from the same industry, Adherex Technologies Inc. (FENC - Free Report) , has yet to report results for the quarter ended March 2026.
This company is expected to post quarterly loss of $0.02 per share in its upcoming report, which represents a year-over-year change of +50%. The consensus EPS estimate for the quarter has been revised 2.4% lower over the last 30 days to the current level.
Adherex Technologies Inc.'s revenues are expected to be $13.94 million, up 59.3% from the year-ago quarter.
Iovance Biotherapeutics, Inc. markets Amtagvi, a TIL therapy for advanced melanoma, and just reported Q1 earnings. Following Q1 results, IOVA shares declined over 13%, closing at $3.55, with a market cap of $1.59bn. The earnings announcement triggered a notable sell-off, reflecting investor concerns about near-term performance.
Key Takeaways IOVA posted Q1 revenue growth of 45%, but sales missed estimates and shares fell 13%.Amtagvi generated about $60M in Q1 sales as referrals and earlier treatment use improved.Iovance expects 2026 product revenues of $350M-$370M, led primarily by Amtagvi. Iovance Biotherapeutics (IOVA - Free Report) incurred a first-quarter 2026 loss of 19 cents per share, in line with the Zacks Consensus Estimate. In the year-ago quarter, the company reported a loss of 36 cents.
Total revenues for the quarter rose 45% year over year to $71.4 million, generated entirely from the sales of the company’s two marketed drugs. The top line missed the Zacks Consensus Estimate of $77.1 million.
IOVA's Earnings in DetailIovance currently has two marketed drugs in its portfolio — the IL-2 product Proleukin and the TIL therapy Amtagvi. While Proleukin is approved to treat metastatic renal cell carcinoma and metastatic melanoma in adults, Amtagvi is approved for the advanced melanoma indication.
The company recorded approximately $60 million from Amtagvi sales during the quarter, up 38% from the year-ago period. Demand trends improved through the quarter, with management pointing to accelerating referrals and earlier use in the treatment pathway as awareness builds across treatment centers. Yet, the drug’s sales missed the Zacks Consensus Estimate and our model estimate, each pegged at $70 million.
Proleukin sales rose 91% to about $11 million during the quarter, benefiting from its use alongside Amtagvi. The figure also missed the Zacks Consensus Estimate and our model estimate, both pegged at $23 million.
Shares of Iovance plunged 13% yesterday, likely due to the soft sales performance of both therapies.
Still, the stock has rallied 30% so far this year against the industry’s 2% decline.
Image Source: Zacks Investment Research
IOVA Reduces Operating Costs While Extending Cash RunwayResearch & development expenses totaled $62.5 million in the quarter, down 12% from the year-ago period, reflecting ongoing operational efficiencies alongside pipeline expansion efforts.
Selling, general and administrative expenses declined 11% to about $39 million. Management positioned the cost structure as improving alongside manufacturing centralization and internal efficiency initiatives, aimed at supporting a clearer path to profitability as revenues scale.
As of March 31, 2026, Iovance had cash, cash equivalents and investments of $319 million compared with $303 million in the previous quarter. Management now expects its existing cash balance to fund operations into 2028 (previously: third-quarter 2027), driven by ongoing cost discipline alongside revenue growth and improving manufacturing leverage.
Iovance discussed its approach to financing on the call, describing its use of the at-the-market facility as opportunistic and aimed at limiting the overall cost of capital while it drives toward breakeven. The company said it continues to evaluate non-dilutive options as it scales commercial execution and advances multiple trials.
IOVA Issues 2026 OutlookIovance expects product revenues for 2026 to be between $350 million and $370 million, with the range described as predominantly fueled by Amtagvi. The company anticipates product revenues for second-quarter 2026 in the range of $86-$88 million, which includes Amtagvi sales between $79 million and $81 million.
On the earnings call, management attributed the tighter quarterly outlook to greater operational visibility, citing improved forecasting around treatment-center activity and manufacturing execution. Leadership also said the commercial organization is focused on expanding capacity and onboarding additional centers over time to support growth through the year.
Updates on IOVA’s Pipeline & Other NewsRegulatory applications for Amtagvi in the melanoma indication are under review, with potential approvals in Australia and Switzerland later this year. Last year, IOVA voluntarily withdrew its regulatory filing in the European Union due to a lack of alignment with the EMA on the clinical data supporting the submission. The company is in discussions with the agency to resubmit a regulatory filing in 2026.
Iovance continues to advance its development programs for Amtagvi. It is evaluating the drug in combination with Merck’s Keytruda in the phase III TILVANCE-301 study as a potential treatment for frontline advanced melanoma. This study will serve as a confirmatory study seeking full approval for Amtagvi in the melanoma indication.
Beyond melanoma, Iovance is developing Amtagvi for other cancer indications. Alongside earnings results, the company reported initial data from the mid-stage IOV-END-201 study evaluating the therapy in previously treated metastatic serous endometrial cancer. Data from the study showed that Amtagvi-treated patients achieved a confirmed objective response rate of 40% and a 100% disease control rate in the first five evaluable patients. Management characterized the setting as an area of high unmet need and said it plans to engage the FDA on an expedited approval pathway.
Amtagvi is being evaluated in separate mid-stage studies for cervical cancer and non-small cell lung cancer indications.
IOVA’s Zacks RankIovance currently carries a Zacks Rank #3 (Hold).
Our Key Picks Among Biotech StocksSome better-ranked stocks from the sector are Amarin Corporation (AMRN - Free Report) and Indivior Pharmaceuticals (INDV - Free Report) , each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Amarin’s 2026 loss per share have narrowed from $7.01 to $6.36. Over the same period, loss per share estimates for 2027 have improved from $5.50 to $4.64. AMRN shares have risen 6% year to date.
Amarin’s earnings beat estimates in three of the trailing four quarters but missed the mark on one occasion, delivering an average surprise of 50.02%.
Over the past 60 days, estimates for Indivior Pharmaceuticals’ 2026 EPS have increased from $3.03 to $3.35. Over the same period, EPS estimates for 2027 have risen to $3.69 from $3.46. INDV shares have risen 10% year to date.
Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 65.44%.
SAN CARLOS, Calif., May 21, 2026 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, today announced that Fred Vogt, PhD, Interim CEO, President and General Counsel, and Corleen Roche, Chief Financial Officer, will participate in a fireside chat at the 2026 Jefferies Global Healthcare Conference on June 4, 2026, at 1:25 p.m. ET in New York, NY.
The live and archived webcast will be available at https://ir.iovance.com/news-events/events-presentations.
About Iovance Biotherapeutics, Inc.
Iovance Biotherapeutics, Inc. aims to be the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) therapies for patients with cancer. We are pioneering a transformational approach to cure cancer by harnessing the human immune system’s ability to recognize and destroy diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. Iovance’s Amtagvi® is the first FDA-approved T cell therapy for a solid tumor indication. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, that may extend and improve life for patients with cancer. For more information, please visit www.iovance.com.
Amtagvi ® and its accompanying design marks, Proleukin®, Iovance®, and IovanceCares™ are trademarks and registered trademarks of Iovance Biotherapeutics, Inc. or its subsidiaries. All other trademarks and registered trademarks are the property of their respective owners.
Forward-Looking Statements
Certain matters discussed in this press release are “forward-looking statements” of Iovance Biotherapeutics, Inc. (hereinafter referred to as the “Company,” “we,” “us,” or “our”) within the meaning of the Private Securities Litigation Reform Act of 1995 (the “PSLRA”). Without limiting the foregoing, we may, in some cases, use terms such as “predicts,” “believes,” “potential,” “achievable,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “forecast,” “guidance,” “outlook,” “may,” “can,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes and are intended to identify forward-looking statements. Forward-looking statements are based on assumptions and assessments made in light of management’s experience and perception of historical trends, current conditions, expected future developments, and other factors believed to be appropriate. Forward-looking statements in this press release are made as of the date of this press release, and we undertake no duty to update or revise any such statements, whether as a result of new information, future events or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties, and other factors, many of which are outside of our control, that may cause actual results, levels of activity, performance, achievements, and developments to be materially different from those expressed in or implied by these forward-looking statements. Important factors that could cause actual results, developments, and business decisions to differ materially from forward-looking statements are described in the sections titled "Risk Factors" in our filings with the U.S. Securities and Exchange Commission, including our most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q.
May 22, 2026 17:15 ET | Source: Iovance Biotherapeutics, Inc.
SAN CARLOS, Calif., May 22, 2026 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) ("Iovance" or the “Company”), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (“TIL”) therapies for patients with cancer, today announced that on May 21, 2026 (the “Date of Grant”), the Company approved the grant of inducement stock options covering an aggregate of 93,340 shares of Iovance’s common stock to thirteen new, non-executive employees.
The awards were granted under Iovance’s Amended and Restated 2021 Inducement Plan, which provides for the granting of equity awards to new employees of Iovance by the Company’s compensation committee in accordance with Nasdaq Listing Rule 5635(c)(4). Each of the stock options granted as referenced in this press release has an exercise price of $3.70, the closing price of Iovance’s common stock on the Date of Grant. Each stock option vests over a three-year period, with one-third of the shares vesting on the first anniversary of the employee’s start date (the “First Vesting Date”) and the remaining shares vesting in eight quarterly installments over the next two years, commencing with the first quarter following the First Vesting Date, subject to continued employment with the Company through the applicable vesting dates.
About Iovance Biotherapeutics, Inc.
Iovance Biotherapeutics, Inc. aims to be the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (“TIL”) therapies for patients with cancer. We are pioneering a transformational approach to cure cancer by harnessing the human immune system’s ability to recognize and destroy diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. Iovance’s Amtagvi® is the first FDA-approved T cell therapy for a solid tumor indication. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, that may extend and improve life for patients with cancer. For more information, please visit www.iovance.com.
Amtagvi® and its accompanying design marks, Proleukin®, Iovance®, and IovanceCares™ are trademarks and registered trademarks of Iovance Biotherapeutics, Inc. or its subsidiaries. All other trademarks and registered trademarks are the property of their respective owners.
Forward-Looking Statements
Certain matters discussed in this press release are “forward-looking statements” of Iovance Biotherapeutics, Inc. (hereinafter referred to as the “Company,” “we,” “us,” or “our”) within the meaning of the Private Securities Litigation Reform Act of 1995 (the “PSLRA”). Without limiting the foregoing, we may, in some cases, use terms such as “predicts,” “believes,” “potential,” “achievable,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “forecast,” “guidance,” “outlook,” “may,” “can,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes and are intended to identify forward-looking statements. Forward-looking statements are based on assumptions and assessments made in light of management’s experience and perception of historical trends, current conditions, expected future developments, and other factors believed to be appropriate. Forward-looking statements in this press release are made as of the date of this press release, and we undertake no duty to update or revise any such statements, whether as a result of new information, future events or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties, and other factors, many of which are outside of our control, that may cause actual results, levels of activity, performance, achievements, and developments to be materially different from those expressed in or implied by these forward-looking statements. Important factors that could cause actual results, developments, and business decisions to differ materially from forward-looking statements are described in the sections titled "Risk Factors" in our filings with the U.S. Securities and Exchange Commission, including our most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q.
Key Takeaways Agenus advanced BOT/BAL into phase III for MSS mCRC and expanded access programs in Europe.IOVA posted 38% Amtagvi sales growth in Q1 2026 as treatment center adoption increased.Iovance targets $350M-$370M in 2026 product revenues led by Amtagvi and pipeline expansion. Both Agenus (AGEN - Free Report) and Iovance Biotherapeutics (IOVA - Free Report) are small-cap companies focused on next-generation cancer immunotherapies and cell-based oncology treatments.
Iovance is a commercial-stage biotech company that markets two approved therapies and is focused on advancing tumor-infiltrating lymphocyte (TIL) cell therapies for solid tumors. On the other hand, Agenus remains a clinical-stage biotech company focused on developing experimental immuno-oncology therapies.
Let's examine the fundamentals of the two stocks to make a prudent choice.
The Case for AGENThis Massachusetts-based company is emerging as a high-risk, high-reward immuno-oncology play centered on its lead botensilimab/balstilimab (BOT/BAL) combination therapy. Although Agenus has no marketed products in its portfolio, investor focus remains tied to pipeline progress, which is expected to support the company’s long-term growth.
The biggest catalyst for Agenus is the advancement of BOT/BAL into late-stage development for microsatellite-stable (MSS) metastatic colorectal cancer (mCRC), an area with significant unmet need and limited treatment options. The company recently initiated the global phase III BATTMAN study, marking an important milestone for the program. The study is being conducted in partnership with the Canadian Cancer Trials Group across multiple international regions.
The program has also generated encouraging clinical data so far. Per Agenus, BOT/BAL has been evaluated in roughly 1,300 patients across more than nine tumor types. Last year, the company reported long-term follow-up data from an early-stage study in heavily pretreated MSS mCRC. In the study, treatment achieved about 42% two-year overall survival and a median overall survival of nearly 21 months. According to Agenus, these findings form part of the broader clinical evidence supporting its plans to seek accelerated approval in the United States and conditional approval in the European Union.
Beyond clinical development, Agenus is also expanding physician access to BOT/BAL through regulatory-authorized pathways in select countries. France has broadened reimbursed access for eligible patients under its AAC framework, while named-patient programs continue to expand across parts of Europe and Latin America. The company has also started recognizing revenues from these programs.
AGEN has additionally taken steps to strengthen its balance sheet and operational flexibility through strategic collaborations. Earlier this year, Agenus expanded its partnership with Zydus Lifesciences, which included manufacturing-related transactions and regional commercialization rights for BOT/BAL in select markets.
However, Agenus faces intense competition in the immuno-oncology space. The company competes against well-established therapies such as Merck’s (MRK - Free Report) Keytruda and Bristol Myers Squibb’s (BMY - Free Report) Opdivo and Yervoy, which already hold strong commercial positions across multiple cancer indications. This creates a significant challenge for smaller biotech companies attempting to gain market share.
The Case for IOVAIn contrast, Iovance markets two products — the TIL therapy Amtagvi and the IL-2 product Proleukin. While Amtagvi is approved for advanced melanoma, Proleukin is approved to treat metastatic renal cell carcinoma and metastatic melanoma indications.
Amtagvi is the first FDA-approved, individualized, one-time cell therapy for melanoma patients. In the first quarter of 2026, Iovance generated about $60 million from Amtagvi’s sales, up 38% year over year, driven by higher patient enrollments and expanding treatment center adoption. Management expects this commercial momentum to continue through the remainder of the year.
Strong Amtagvi uptake is also expected to support Proleukin sales, as the drug is used as part of the Amtagvi treatment regimen. IOVA expects to generate total product revenues between $350 million and $370 million in 2026, with Amtagvi accounting for the majority of sales.
The company is evaluating Amtagvi across several label expansion studies in other cancer indications, which include cervical cancer, endometrial cancer, non-small cell lung cancer (NSCLC), and head and neck squamous cell carcinoma (HNSCC) indications. Iovance is on track to submit a regulatory filing with the FDA for the drug in the NSCLC indication later this year.
Beyond melanoma, Iovance is evaluating Amtagvi across multiple label expansion opportunities, including cervical cancer, endometrial cancer, non-small cell lung cancer (NSCLC) and head and neck squamous cell carcinoma (HNSCC). The company remains on track to submit a regulatory filing to the FDA for Amtagvi in NSCLC later this year, which could significantly expand the drug’s commercial opportunity.
Iovance is advancing several early-stage pipeline candidates. It is currently evaluating IOV-2001 in relapsed/refractory chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL) in a phase I/II study. Another phase I/II study is evaluating the company’s first TALEN-edited TIL therapy candidate, IOV-4001, in patients with advanced melanoma and metastatic NSCLC across two separate cohorts. The company is assessing IOV-3001, a second-generation modified IL-2 analog, for use in the TIL therapy treatment regimen in a phase I/II study.
However, regulatory and competitive risks remain key overhangs for Iovance. Last year, the company withdrew its EU filing for Amtagvi after failing to align with the EMA on supporting clinical data, delaying its European expansion plans. Iovance faces strong competition in immuno-oncology from pharma giants like Bristol Myers and Merck. It also competes with emerging cell-therapy developers like Immatics and KSQ Therapeutics.
How Do Estimates Compare for AGEN & IOVA?For Agenus, the Zacks Consensus Estimate for 2026 sales suggests 19.5% year-over-year growth, while earnings estimates indicate that EPS could improve by about 143%. However, bottom-line estimates for 2026 have moved lower over the past 30 days.
Image Source: Zacks Investment Research
The Zacks Consensus Estimate for Iovance’s 2026 sales implies 42.2% year-over-year growth, while loss estimates per share are projected to improve by 42.2%. However, bottom-line estimates for 2026 have declined over the past 30 days.
Image Source: Zacks Investment Research
Price Performance and Valuation of AGEN & IOVAYear to date, shares of IOVA have surged 60%, while those of AGEN have risen nearly 9%. In comparison, the industry has lost about 0.5%, as seen in the chart below.
Image Source: Zacks Investment Research
From a valuation standpoint, Iovance Biotherapeutics seems to be trading at a premium compared to Agenus, going by the price/sales (P/S) ratio. IOVA’s shares currently trade at 6.40 times trailing 12-month sales, higher than 1.05 for AGEN.
Image Source: Zacks Investment Research
AGEN or IOVA: Which Is a Better Pick?Both stocks have a Zacks Rank #3 (Hold), which makes choosing one over the other difficult. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Iovance seems to be the safer pick at present, despite its premium valuation. The company benefits from a longer growth runway, supported by the expanding commercial opportunity for Amtagvi and multiple ongoing label-expansion and pipeline programs. Agenus, on the other hand, has a more concentrated portfolio with no stable stream of revenues.
Next-Generation Platform Expands into Solid Tumors
Representing 100,000+ U.S. Deaths Annually
SAN CARLOS, Calif., June 01, 2026 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, today announced allowance to proceed from the U.S. Food and Drug Administration (FDA) for the investigational new drug (IND) application for a Phase 1/2 basket trial of IOV-5001, a next-generation interleukin-12 (IL-12) tethered TIL therapy.
The Phase 1/2 trial will begin enrolling in the second half of 2026 to investigate the safety and efficacy of a one-time IOV-5001 treatment regimen without the use of IL-2. Cohorts include advanced colorectal, triple-negative, and estrogen receptor-low breast cancers, as well as other highly prevalent solid tumors representing more than 100,000 U.S. deaths annually.1
IOV-5001 is engineered to express IL-12 only within the tumor to enhance efficacy, particularly in cancers caused by immunologically cold tumors, and to tether IL-12 to the cell surface to prevent release into the bloodstream to optimize safety. IOV-5001 is designed to safely deliver significantly higher cell doses and improve upon an earlier secreted IL-12 TIL therapy that showed a 63% confirmed objective response rate.2
“Proceeding into the clinical trial of IOV-5001 is a defining moment as we extend our TIL platform across additional prevalent solid tumors,” said Frederick Vogt, Ph.D., J.D., Interim Chief Executive Officer and President of Iovance. “By tethering IL-12 to the TIL cell surface and targeting its activity inside the tumor, IOV-5001 is designed to activate cold tumors and open an entirely new frontier of massive opportunities for TIL cell therapy. We look forward to beginning patient enrollment in the second half of 2026.”
1. Surveillance, Epidemiology, and End Results Program Cancer Stat Facts (accessed May 2026).
2. Zhang L, Rosenberg SA, et al, Clin Cancer Res 2015;21(10):2278–2288.
About IOV-5001
IOV-5001 is an investigational second-generation TIL therapy engineered to express IL-12 only inside the tumor, where it is anchored to the TIL cell surface rather than released into the bloodstream. This design is intended to deliver the antitumor benefit seen with earlier IL-12 TIL therapies while avoiding systemic toxicity. In preclinical studies, IOV-5001 showed stronger antitumor activity and a healthier, more durable T cell profile than unmodified TIL therapies.
About Iovance Biotherapeutics, Inc.
Iovance Biotherapeutics, Inc. aims to be the global leader in innovating, developing, and delivering TIL therapies for patients with cancer. We are pioneering a transformational approach to cure cancer by harnessing the human immune system’s ability to recognize and destroy diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. Iovance’s Amtagvi® is the first FDA-approved T cell therapy for a solid tumor indication. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, that may extend and improve life for patients with cancer. For more information, please visit www.iovance.com.
Amtagvi® and its accompanying design marks, Proleukin®, Iovance®, and IovanceCares™ are trademarks and registered trademarks of Iovance Biotherapeutics, Inc. or its subsidiaries. All other trademarks and registered trademarks are the property of their respective owners.
Forward-Looking Statements
Certain matters discussed in this press release are “forward-looking statements” of Iovance Biotherapeutics, Inc. (hereinafter referred to as the “Company,” “we,” “us,” or “our”) within the meaning of the Private Securities Litigation Reform Act of 1995 (the “PSLRA”). Without limiting the foregoing, we may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “forecast,” “guidance,” “outlook,” “may,” “can,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes and are intended to identify forward-looking statements. Forward-looking statements are based on assumptions and assessments made in light of management’s experience and perception of historical trends, current conditions, expected future developments, and other factors believed to be appropriate. Forward-looking statements in this press release are made as of the date of this press release, and we undertake no duty to update or revise any such statements, whether as a result of new information, future events or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties, and other factors, many of which are outside of our control, that may cause actual results, levels of activity, performance, achievements, and developments to be materially different from those expressed in or implied by these forward-looking statements. Important factors that could cause actual results, developments, and business decisions to differ materially from forward-looking statements are described in the sections titled "Risk Factors" in our filings with the U.S. Securities and Exchange Commission, including our most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, and include, but are not limited to, the following substantial known and unknown risks and uncertainties inherent in our business: the risks related to our ability to successfully commercialize our products; the acceptance by the market of our products and product candidates, if approved, and their potential pricing and/or reimbursement by payors, and whether such acceptance is sufficient to support continued commercialization or development of our products or product candidates; the risk regarding our ability to manufacture our therapies at our Iovance Cell Therapy Center facility, including the risk that our ability to increase manufacturing capacity at our facility may adversely affect our commercial launch; the risk that the successful development or commercialization of our products may not generate sufficient revenue from product sales, and we may not become profitable in the near term, or at all; the risks related to the timing of and our ability to successfully develop, submit, obtain, or maintain regulatory authority approval of our product candidates; whether clinical trial results from our pivotal studies and cohorts, and meetings with regulatory authorities may support registrational studies and subsequent approvals by regulatory authorities, including the risk that the planned registrational trial in advanced sarcomas may not support approval; preliminary and interim clinical results, which may include efficacy and safety results, from ongoing clinical trials or cohorts may not be reflected in the final analyses of our ongoing clinical trials or subgroups within these trials or in other prior trials or cohorts; the risk that we may be required to conduct additional clinical trials or modify ongoing or future clinical trials based on feedback from regulatory authorities; the risk that our interpretation of the results of our clinical trials or communications with regulatory authorities may differ from the interpretation of such results or communications by such regulatory authorities; the risk that clinical data from ongoing clinical trials of Amtagvi will not continue or be repeated in ongoing or planned clinical trials or may not support regulatory approval or renewal of authorization; the risk that unanticipated expenses may decrease our estimated cash balances and forecasts and increase our estimated capital requirements; the risk that we may not be able to recognize revenue for our products; the risk that Proleukin revenues, and other factors such as the number of authorized treatment centers, may not serve as a leading indicator for Amtagvi revenues; the risks regarding our anticipated operating and financial performance, including our financial guidance and projections; the effects of global and domestic geopolitical factors or public health events; and other factors, including general economic conditions and regulatory developments, not within our control. Any financial guidance provided in this press release assumes the following: no material change in our ability to manufacture our products; no material change in payor coverage; no material change in revenue recognition policies; no new business development transactions not completed as of the period covered by this press release; and no material fluctuation in exchange rates.
Iovance Biotherapeutics (NASDAQ:IOVA) said it has obtained clearance of an Investigational New Drug application for IOV-5001, extending its next-generation cell therapy platform into solid tumors the company said account for more than 100,000 US deaths a year.
The clearance allows Iovance to begin clinical work on IOV-5001 and marks the platform's move beyond its current focus and into the solid tumor setting.
The company framed the expansion around the size of the unmet need, pointing to the tens of thousands of annual US deaths in the targeted tumor types.
An IND clearance is the regulatory step that permits a company to start human testing of an experimental therapy in the United States. Carrying its next-generation platform into solid tumors widens the range of cancers Iovance's cell therapy approach could address and adds IOV-5001 to the programs the company is advancing toward the clinic.
Iovance did not detail the trial design or timing in the announcement.
Iovance Biotherapeutics is a commercial-stage biotechnology company developing cell therapies for the treatment of cancer.
Iovance Biotherapeutics (NASDAQ:IOVA) said it has obtained clearance of an Investigational New Drug application for IOV-5001, extending its next-generation cell therapy platform into solid tumors the company said account for more than 100,000 US deaths a year.
The clearance allows Iovance to begin clinical work on IOV-5001 and marks the platform's move beyond its current focus and into the solid tumor setting.
The company framed the expansion around the size of the unmet need, pointing to the tens of thousands of annual US deaths in the targeted tumor types.
An IND clearance is the regulatory step that permits a company to start human testing of an experimental therapy in the United States. Carrying its next-generation platform into solid tumors widens the range of cancers Iovance's cell therapy approach could address and adds IOV-5001 to the programs the company is advancing toward the clinic.
Iovance did not detail the trial design or timing in the announcement.
Iovance Biotherapeutics is a commercial-stage biotechnology company developing cell therapies for the treatment of cancer.
Iovance Biotherapeutics (IOVA +4.76%) is not for the faint of heart. While shares in this biotech company are up 50% year to date and over 125% over the past 12 months, the stock has experienced high volatility in the past.
In fact, Iovance is down nearly 80% over the past five years. Results and updates may be better than feared now, but disappointment could still arise. While risk is high, certain factors at play may make Iovance one of the biotech stocks worth a closer look.
Image source: Getty Images.
The bull case for Iovance Biotherapeutics Iovance focuses on developing tumor-infiltrating lymphocytes (TILs) for cancer treatment. The company has reached the commercialization stage, with melanoma treatment Amtagvi as its flagship drug. Previously, Iovance's management has suggested that Amtagvi could eventually become a blockbuster drug, with peak annual sales exceeding $1 billion.
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However, it's taken significant time and capital to bring this drug to market. To sustain itself, Iovance has often tapped into dilutive sales of newly issued stock. While promising figures have helped spark a comeback for Iovance, shares took a brief dive earlier this month after the company reported a revenue miss. Iovance reported $71 million in sales, while sell-side analysts expected around $75.6 million.While not fully back in favor yet, there are substantive reasons why the risk/reward proposition with stock is in one's favor.
What makes this risky biotech stock stand out Although first-quarter results fell short of expectations, the company did report 45% year-over-year sales growth. Management's latest guidance updates suggest 30% to 40% revenue growth for the full year . High sales growth could persist, especially as Iovance advances its TIL therapy pipeline for other cancer types.
With $319 million in cash on hand, management believes this is enough to fund operations through 2028, suggesting a low risk of near-term shareholder dilution. If Iovance can continue to ramp up Amtagvi sales while advancing its clinical trials, shares could keep retesting prior price levels.
Keep in mind Iovance's high risk, but consider it one of the stronger plays in this space right now.
Thomas Niel has no position in any of the stocks mentioned. The Motley Fool has positions in and recommends Iovance Biotherapeutics. The Motley Fool has a disclosure policy.
First T cell therapy for a solid tumor cancer and first treatment option approved in Australia for advanced melanoma after anti-PD-1 and targeted therapy
SAN CARLOS, Calif., June 03, 2026 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, today announced that the Therapeutic Goods Administration (TGA) of Australia granted approval with conditions of Amtagvi® (lifileucel), a tumor-derived autologous T cell immunotherapy, for previously treated advanced (metastatic or unresectable) melanoma. Amtagvi is 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.
“This approval in Australia is our third marketing authorization for Amtagvi and marks a significant step forward for Iovance in the country with the highest rate of melanoma globally,” said Frederick Vogt, Ph.D., J.D., Interim Chief Executive Officer and President of Iovance. “We are in the process of authorizing our first Australian treatment center as we advance our expansion strategy for Amtagvi in additional markets with a high prevalence of advanced melanoma.”
Australia has the highest rate of melanoma globally, with an estimated 17,000 new cases diagnosed each year and more than 1,500 deaths annually.1,2 Similar to the U.S. and other global markets, there is a significant need for new therapies for patients with advanced melanoma.
TGA granted approval based on safety and efficacy results from the global, multicenter C-144-01 trial investigating Amtagvi in patients with advanced melanoma previously treated with anti-PD-1 therapy and targeted therapy, if applicable.
About the C-144-01 Clinical Trial
C-144-01 is a global, multicenter Phase 2 study in which patients received lifileucel monotherapy. The study enrolled patients with metastatic melanoma who were previously treated with at least one systemic therapy, including a PD-1 blocking antibody, and, if BRAF V600 mutation positive, a BRAF inhibitor or a BRAF inhibitor with a MEK inhibitor. Efficacy was established on the basis of objective response rate (ORR) and duration of response (DOR) by Independent Review Committee (IRC) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The detailed results of C-144-01 were published in the Journal for ImmunoTherapy of Cancer in 2022. A five-year analysis of C-144-01 was published in the Journal of Clinical Oncology in 2025.
Iovance is investigating Amtagvi in frontline advanced melanoma in the Phase 3 trial, TILVANCE-301 (NCT05727904), as well as in additional solid tumor types.
About Iovance Biotherapeutics, Inc.
Iovance Biotherapeutics, Inc. aims to be the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) therapies for patients with cancer. We are pioneering a transformational approach to cure cancer by harnessing the human immune system’s ability to recognize and destroy diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. Iovance’s Amtagvi® is the first FDA-approved T cell therapy for a solid tumor indication. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, that may extend and improve life for patients with cancer. For more information, please visit www.iovance.com.
Amtagvi ® and its accompanying design marks, Proleukin®, Iovance®, and IovanceCares™ are trademarks and registered trademarks of Iovance Biotherapeutics, Inc. or its subsidiaries. All other trademarks and registered trademarks are the property of their respective owners.
1. Cancer Australia, Melanoma of the Skin Statistics, https://www.canceraustralia.gov.au/cancer-types/melanoma-skin/melanoma-skin-statistics (Accessed March 2026)
2. Melanoma Institute Australia, Melanoma Facts, https://melanoma.org.au/about-melanoma/melanoma-facts/ (Accessed March 2026)
Forward-Looking Statements
Certain matters discussed in this press release are “forward-looking statements” of Iovance Biotherapeutics, Inc. (hereinafter referred to as the “Company,” “we,” “us,” or “our”) within the meaning of the Private Securities Litigation Reform Act of 1995 (the “PSLRA”). Without limiting the foregoing, we may, in some cases, use terms such as “predicts,” “believes,” “potential,” “achievable,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “forecast,” “guidance,” “outlook,” “may,” “can,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes and are intended to identify forward-looking statements. Forward-looking statements are based on assumptions and assessments made in light of management’s experience and perception of historical trends, current conditions, expected future developments, and other factors believed to be appropriate. Forward-looking statements in this press release are made as of the date of this press release, and we undertake no duty to update or revise any such statements, whether as a result of new information, future events or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties, and other factors, many of which are outside of our control, that may cause actual results, levels of activity, performance, achievements, and developments to be materially different from those expressed in or implied by these forward-looking statements. Important factors that could cause actual results, developments, and business decisions to differ materially from forward-looking statements are described in the sections titled "Risk Factors" in our filings with the U.S. Securities and Exchange Commission, including our most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, and include, but are not limited to, the following substantial known and unknown risks and uncertainties inherent in our business: the risks related to our ability to successfully commercialize our products; the acceptance by the market of our products and product candidates, if approved, and their potential pricing and/or reimbursement by payors, and whether such acceptance is sufficient to support continued commercialization or development of our products or product candidates; the risk regarding our ability to manufacture our therapies at our Iovance Cell Therapy Center facility, including the risk that our ability to increase manufacturing capacity at our facility may adversely affect our commercial launch; the risk that the successful development or commercialization of our products may not generate sufficient revenue from product sales, and we may not become profitable in the near term, or at all; the risks related to the timing of and our ability to successfully develop, submit, obtain, or maintain regulatory authority approval of our product candidates; whether clinical trial results from our pivotal studies and cohorts, and meetings with regulatory authorities may support registrational studies and subsequent approvals by regulatory authorities, including the risk that the planned registrational trial in advanced sarcomas may not support approval; preliminary and interim clinical results, which may include efficacy and safety results, from ongoing clinical trials or cohorts may not be reflected in the final analyses of our ongoing clinical trials or subgroups within these trials or in other prior trials or cohorts; the risk that we may be required to conduct additional clinical trials or modify ongoing or future clinical trials based on feedback from regulatory authorities; the risk that our interpretation of the results of our clinical trials or communications with regulatory authorities may differ from the interpretation of such results or communications by such regulatory authorities; the risk that clinical data from ongoing clinical trials of Amtagvi will not continue or be repeated in ongoing or planned clinical trials or may not support regulatory approval or renewal of authorization; the risk that unanticipated expenses may decrease our estimated cash balances and forecasts and increase our estimated capital requirements; the risk that we may not be able to recognize revenue for our products; the risk that Proleukin revenues, and other factors such as the number of authorized treatment centers, may not serve as a leading indicator for Amtagvi revenues; the risks regarding our anticipated operating and financial performance, including our financial guidance and projections; the effects of global and domestic geopolitical factors or public health events; and other factors, including general economic conditions and regulatory developments, not within our control. Any financial guidance provided in this press release assumes the following: no material change in our ability to manufacture our products; no material change in payor coverage; no material change in revenue recognition policies; no new business development transactions not completed as of the period covered by this press release; and no material fluctuation in exchange rates.
