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SAN CARLOS, Calif., Sept. 04, 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 senior leadership plans to present at the following upcoming conferences:

Wells Fargo 21st Annual Healthcare Conference
Fireside Chat: September 10, 2026, at 11:00 a.m. ET
Boston, MA H.C. Wainwright 28th Annual Global Investment Conference
Presentation: September 15, 2026, at 4:00 p.m. ET
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.  is the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) cell therapies for patients with solid tumors. Amtagvi® (lifileucel) is the first FDA-approved, one-time treatment for previously treated advanced melanoma, now approved in three global markets and available at more than 95 authorized treatment centers. The Iovance TIL platform spans registrational trials and next-generation programs in additional solid tumors, including gene-edited and IL-12 tethered TIL therapies, next-generation IL-2, and precision immuno-oncology approaches. As the first and only company to take TIL therapy from concept to a broadly accessible commercial treatment, Iovance operates as an end-to-end cell therapy company, anchored by fully owned, centralized U.S.-based manufacturing that is scaled to serve thousands of cancer patients worldwide each year. 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.

Information on Iovance’s broad, industry-leading patent portfolio is available on the Intellectual Property page on www.iovance.com.

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.

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For Immediate ReleaseChicago, IL – August 27, 2026 – Today, Zacks Equity Halozyme Therapeutics (HALO - Free Report) , Repligen (RGEN - Free Report) , Iovance Biotherapeutics (IOVA - Free Report) , Arcutis Biotherapeutics (ARQT - Free Report) and Precigen (PGEN - Free Report)

Industry: Biotechs

Link: https://www.zacks.com/commentary/2980200/5-biotech-stocks-worth-adding-to-your-portfolio-now

The biotechnology industry has demonstrated resilience so far this year despite an uncertain economic backdrop. Strong quarterly results, new drug approvals and positive clinical and pipeline developments have supported sector momentum despite ongoing pricing pressures, regulatory hurdles and broader market volatility. With demand for innovative therapies remaining resilient across economic cycles, the biotech sector is well positioned to sustain investor interest and capitalize on long-term growth opportunities.

The recent revival in mergers and acquisitions (M&A) activity following a period of slowdown, fueled by an evolving industry landscape and growing interest in AI-powered drug discovery, has provided an additional boost to the sector. Large pharmaceutical and biotechnology companies continue to strengthen their product portfolios and pipelines through strategic collaborations, licensing agreements and acquisitions as they seek to reshape their business models and counter increasing generic competition for key drugs. Against this backdrop, smaller biotech companies developing breakthrough technologies and novel therapies are attracting greater attention from larger industry players and investors, helping sustain momentum across the broader biotechnology sector.

Biotech companies like Halozyme Therapeutics, Repligen, Iovance Biotherapeutics, Arcutis Biotherapeutics and Precigen are poised to outperform the sector. 

Zacks Industry DescriptionThe Zacks Biomedical and Genetics industry comprises biopharmaceutical and biotechnology companies that develop high-profile drugs utilizing groundbreaking technology. These biologically processed drugs, which address virology, neuroscience, metabolism and rare diseases, are manufactured using live organisms.

As technology becomes increasingly crucial to improving global health, biotech companies strive to utilize innovative technologies to rapidly develop breakthrough treatments. Several companies in this field are developing drugs and vaccines utilizing modern technology. Given the dynamic and evolving nature of technology, the sector seems riskier than the large-cap pharma or drug industry. 

4 Trends Shaping the Future of the Biotech IndustryInnovation and Execution Hold the Key: The primary focus in the biotech industry is on the performance of high-profile drugs and innovative pipeline development, as only a handful of companies in this industry have approved drugs in their portfolios. Most companies spend millions and billions of dollars to create a drug with path-breaking technology, resulting in significant research and development expenditures. The growing focus on using AI technology in drug discovery is driving additional investment into the industry. Precision medicine, also known as personalized medicine, is another rapidly evolving field in the industry.

On the other hand, successful commercialization is crucial for a drug to become a revenue generator for the company. Smaller biotechs often lack the necessary funds and expertise to reach the target population. This prompts collaboration deals with either pharma or biotech bigwigs, wherein sales are shared or royalties are received.

Sometimes, approved treatments come with side effects that emerge over time, and the uptake may fail to meet expectations. Hence, it takes several years before a biotech company turns profitable. Moreover, it may take quite a few years for any newly approved drug to contribute to its company’s top line.

M&A in the Spotlight: Consolidation has long been a key theme in the pharma and biotech industry, as leading companies continually seek to diversify their revenue streams amid declining sales from their flagship drugs. The recent spree of acquisitions signifies a focus on portfolio expansion and constant pipeline innovation, given the changing landscape and spotlight on AI-driven drug discovery.

Bigwigs in the space are also entering into licensing deals and collaborations for promising drugs and candidates to strengthen and expand their portfolios and pipelines in core areas and emerging fields. While oncology and immuno-oncology companies have traditionally been prime acquisition targets, the lucrative obesity and gene-editing spaces are also attracting growing interest.

Pharma giants like Eli Lilly and Novartis have been on an acquisition spree this year, strengthening their already diverse portfolios further. On the biotech front, Gilead Sciences has been quite active. Gilead’s recent aggressive dealmaking strategy, including the acquisitions of Arcellx and Tubulis, underscores its commitment to diversifying beyond its core HIV franchise and expanding into higher-growth oncology and immunology markets.

The recent spotlight on the usage of AI technology for drug discovery should lure further investment in this industry.

New Drug Approvals Strengthen Growth Prospects: New drug approvals have accelerated so far this year, with 33 novel drugs receiving the green light, as pharmaceutical and biotechnology companies seek to expand and diversify their product portfolios and strengthen long-term growth prospects.

Pipeline Setbacks & Potential Tariffs Weigh on Outlook: Pipeline setbacks are key deterrents for biotech companies, given the exorbitant cost of developing drugs using expensive technology. Most drugs/therapies take years to gain a regulatory nod. An unfavorable outcome from a crucial trial on a promising candidate is a huge setback, particularly for smaller biotechs, which are mostly one-trick ponies. The leading biotechs face other headwinds, including declining sales of high-profile drugs due to intensifying competition.

Moreover, ongoing geopolitical tensions remain a headwind. 

Zacks Industry Rank Indicates Grim ProspectsThe group’s Zacks Industry Rank is basically the average of the Zacks Rank of all the member stocks.

The Zacks Biomedical and Genetics industry currently carries a Zacks Industry Rank #157, which places it among the bottom 36% of more than 247 Zacks industries. The rank reflects a grim outlook for the space as of now, mostly due to the challenging macroenvironment. 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.

Before we present a few biotech stocks that are well-positioned to beat the industry based on a strong portfolio/pipeline, let’s take a look at the industry’s stock market performance and current valuation.

Industry Versus S&P 500 & SectorThe Zacks Biomedical and Genetics industry is a 665-stock group within the broader Zacks Medical sector. It has outperformed the Zacks Medical sector but lagged the S&P 500 composite sector year to date.

The stocks in this industry have risen 10.7% year to date compared with the Zacks Medical sector’s gain of 6.2%. The S&P 500 composite has gained 11.5% in the same period.

Industry's Current ValuationSince most companies in the biotech sector do not have approved drugs, valuing these becomes a complex process. On the basis of the trailing 12-month price-to-sales ratio (P/S TTM), which is commonly used for valuing biotech companies with approved portfolios of drugs, the industry is currently trading at 2.59X compared with the S&P 500’s 5.86X and the Zacks Medical sector's 4.53X.

Over the past five years, the industry has traded as high as 3.39X, as low as 1.81X and at a median of 2.39X.

5 Biotech Stocks Worth BuyingRepligen is a global life sciences company that develops and commercializes highly innovative bioprocessing technologies and systems that increase efficiencies and flexibility in the process of manufacturing biological drugs. The company is witnessing strong growth across all business segments, driven by healthy order trends.

RGEN’s chromatography and process analytics businesses continue to support revenue growth. The protein business is also seeing strong demand, which should help drive additional growth through 2026. Repligen has made a few promising acquisitions of late to diversify its business or boost its core competencies.

RGEN currently carries a Zacks Rank #1 (Strong Buy). 

Shares of RGEN have gained 10.9% year to date. The Zacks Consensus Estimate for 2026 earnings per share (EPS) has increased to $2.06 from $1.99 in the past 30 days.

Halozyme Therapeutics has collaboration deals related to its ENHANZE technology with several large pharma companies that generate milestone payments, driving the top line. Robust demand for the subcutaneous formulation of Darzalex, Phesgo, and Vyvgart Hytrulo is boosting royalties and the top line. The momentum is likely to continue in the upcoming quarters. Halozyme’s focus on signing new collaboration deals to aid growth bodes well.

HALO currently carries a Zacks Rank #2 (Buy). Shares have surged 62.4% year to date. The Zacks Consensus Estimate for 2026 EPS has increased to $8.19 from $7.96 in the past 60 days.

Iovance Biotherapeutics is focused on developing tumor-infiltrating lymphocyte (TIL) therapies for solid tumors. Iovance’s top line is driven by Amtagvi, the first treatment option for advanced melanoma that has progressed on or after prior anti-PD-1 therapy. The momentum is expected to continue throughout 2026 and beyond, fueled by patient enrolments. This encouraging demand has also driven the surge in Proleukin sales, as the drug is used in the Amtagvi regimen.

Shares of this Rank #2 company have skyrocketed 62.4% year to date.

Arcutis Biotherapeutics, a commercial stage company, has a growing portfolio of advanced targeted topicals approved to treat three major inflammatory skin diseases — plaque psoriasis, seborrheic dermatitis and atopic dermatitis. The company’s lead product Zoryve (roflumilast) cream 0.3% for the treatment of plaque psoriasis has been performing well.

Consistent label expansion of Zoryve has boosted sales. Zoryve topical foam 0.3% is approved for the treatment of seborrheic dermatitis while Zoryve cream 0.15% is approved for the treatment of mild to moderate atopic dermatitis.

ARQT currently carries a Zacks Rank #2.  Shares have gained 17.6% in the past three months. The Zacks Consensus Estimate for 2026 EPS has increased to 40 cents from 15 cents in the past 60 days.

Precigen, a commercial-stage company specializing in innovative precision medicines, is making steady progress with strong commercial performance from its sole marketed drug Papzimeos (zopapogene imadenovec-drba). As the first and only FDA-approved therapy for adults with recurrent respiratory papillomatosis (RRP), Papzimeos provides Precigen with a differentiated commercial position and a potentially durable revenue base. Papzimeos has demonstrated strong early commercial momentum since its launch.

PGEN currently carries a Zacks Rank #2. EPS estimates have improved to 25 cents from a loss per share estimate of 2 cents in the past 60 days. 

You can see the complete list of today’s Zacks #1 Rank stocks here.

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Shares of Iovance Biotherapeutics Inc. (NASDAQ:IOVA) are trending Friday morning, continuing a momentum surge that recently pushed the biotech stock to a new 52-week high after gaining over 250% year-to-date.

Iovance Biotherapeutics stock is building positive momentum. Why is IOVA stock advancing? Spillover Sentiment from Melanoma Breakthroughs While Iovance has not released major news this week, investor enthusiasm has been fueled by positive readout data in the advanced skin cancer sector. Recent interim Phase 3 results from Moderna Inc. and Merck & Co. Inc. demonstrated statistically significant improvements in survival metrics for individualized melanoma treatments.

The positive readouts have reinforced market confidence in advanced melanoma therapies, directly benefiting Iovance as it commercializes its own FDA-approved, one-time cell therapy, Amtagvi.

Strong Earnings and Commercial Execution The stock’s recent strength is further backed by solid fundamental performance. In its second-quarter financial report, Iovance beat expectations with $99.31 million in sales, driven by $91 million in U.S. Amtagvi revenue, and a narrower-than-expected loss of 11 cents per share.

Management reaffirmed full-year 2026 sales guidance of $350 million to $370 million, prompting several Wall Street analysts to raise their price targets.

Iovance Biotherapeutics Technical Levels To WatchIOVA is still in a steep uptrend, with price at $9.18 sitting well above every major moving average: the 20-day SMA ($5.89), 50-day SMA ($4.95), 100-day SMA ($4.33), and 200-day SMA ($3.60). That kind of separation typically signals strong trend control, but it also raises the odds of sharper pullbacks if buyers pause.

RSI is the key momentum tell right now, and at 83.29 it’s firmly overbought—meaning the move is stretched and more vulnerable to consolidation or a fast dip even if the bigger trend stays bullish. The golden cross that formed in January (50-day SMA moving above the 200-day SMA) reinforces that the longer-term trend has been pointing higher for months.

Key Resistance: $9.36 — the 52-week high area from August, where breakouts often need follow-through volume to stick Key Support: $5.89 — near the 20-day SMA, a level that often acts as the first "trend support" during pullbacks IOVA Stock Price Movement Friday MorningIOVA Stock Price Activity: Iovance Biotherapeutics shares were down 0.67% at $8.93 on Friday, according to Benzinga Pro data.

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Iovance Biotherapeutics Inc. (NASDAQ:IOVA) is trading at a 52-week high on Thursday, despite having no news to justify the move. Year to date, the stock has surged over 200%.

• Iovance Biotherapeutics shares are testing new highs. Why did IOVA hit a new high?

The momentum seems to come from breakthrough data from Moderna Inc. (NASDAQ:MRNA) and Merck & Co Inc.‘s (NYSE:MRK) individualized cancer therapy for advanced skin cancer.

On Wednesday, the companies said that at a pre-planned interim analysis, the investigational combination delivered statistically significant and clinically meaningful improvements in recurrence-free survival and distant metastasis-free survival compared to standard Keytruda alone.

Iovance’s Amtagvi Targets Advanced MelanomaInvestors should note that in February 2024, the U.S. Food and Drug Administration (FDA) granted accelerated approval to Iovance’s Amtagvi (lifileucel), a one-time tumor-infiltrating lymphocyte (TIL) therapy.

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It is derived from a patient’s surgically removed tumor, expanded in a lab, and then reinfused into patients.

Indication covers 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.

Iovance is also conducting TILVANCE-301, a Phase 3 trial to confirm clinical benefit.

Moderna/Merck’s intismeran autogene is an mRNA-based individualized neoantigen therapy (INT) designed specifically for each patient based on the unique set of mutations within their tumor to train and activate the immune system to recognize and fight cancer.

Iovance Reports Early Soft-Tissue Sarcoma DataIn February, Iovance shared positive early data from a pilot clinical trial for its TIL cell therapy in advanced soft-tissue sarcomas.

Among the first six evaluable patients treated with lifileucel monotherapy, the trial showed a 50% confirmed objective response rate.

Most recently, the cancer drug company reported a second-quarter loss of 11 cents per share, beating the consensus loss of 14 cents per share.

Sales reached $99.313 million, beating the consensus of $87.832 million. U.S. Amtagvi revenue reached approximately $91 million.

Iovance Biotherapeutics reaffirmed fiscal 2026 sales guidance of $350 million-$370 million versus the consensus of $362.083 million.

Analysts Raise Price ForecastsUBS maintains Iovance Biotherapeutics with a Neutral rating and raises the price target from $4 to $7.

Mizuho reaffirms the Outperform rating for IOVA stock and raises the price target from $10 to $11.

IOVA Stock Price Activity: Iovance Biotherapeutics shares were up 9.64% at $8.76 at the time of publication on Thursday, according to Benzinga Pro data.

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Shares of biopharmaceutical company Iovance Biotherapeutics (IOVA +0.95%) have been skyrocketing lately. The California-based business reported earnings recently, which pleased investors, and that's putting it lightly, as the stock also hit a new 52-week high.

What's gotten investors so bullish on the healthcare stock, and is now a good time to buy it?

Image source: Getty Images.

Amtagvi drives significant sales growth for Iovance in Q2 On Aug. 6, Iovance released its second-quarter earnings numbers, which showed strong growth for its promising cancer treatment, Amtagvi (lifileucel). The company's revenue for the June quarter totaled $99.3 million, which was an increase of 66% from the prior-year period. The lion's share of the company's revenue comes from Amtagvi, which was responsible for $91 million.

The Food and Drug Administration approved Amtagvi in early 2024 as a treatment for unresectable or metastatic melanoma. It has the potential to be a blockbuster for Iovance, as it may bring in more than $1 billion in revenue at its peak. However, how much it generates will depend on its approval for other indications.

In addition to generating significant revenue growth this past quarter, the company also drastically reduced its losses during the period. Iovance's net loss came in at $47.3 million, which was less than half the $111.7 million loss it incurred in the same period last year. As Amtagvi continues to reach more patients and sales grow, there is hope that the business may have a path to profitability, which would make the stock a more attractive investment option for more risk-averse investors.

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Can Iovance's stock soar higher this year? Although Iovance's stock has been red hot of late, I think it can still rise higher. It's down more than 70% over the past five years, and now, with the business having an approved treatment and significant revenue to show for, it's not nearly as risky an investment as it was in the past. And with terrific margins, there's reason to be optimistic that it may get to breakeven in the future. The stock may even become an attractive acquisition target for a larger healthcare company, given its modest market cap of around $3 billion.

There will inevitably be some risk with the stock because of its lack of profitability, but with some tremendous progress and positive signs around Iovance, I wouldn't be surprised if it were to rise a whole lot higher in the long run. This can be an excellent growth stock for investors who are comfortable taking on some risk and uncertainty.

Key Takeaways Iovance beat Q2 estimates as revenues rose 66%, driven by stronger-than-expected Amtagvi sales.IOVA reported higher gross margin, lower R&D costs and said cash can fund operations into late 2028.Iovance is reviewing 2026 revenue guidance as Amtagvi demand strengthens and pipeline programs advance. Iovance Biotherapeutics (IOVA - Free Report) incurred a second-quarter 2026 loss of 11 cents per share, narrower than the Zacks Consensus Estimate of a loss of 17 cents. In the year-ago quarter, the company reported a loss of 33 cents.

Total revenues for the reported quarter rose 66% year over year to $99.3 million, generated entirely from the sales of the company’s two marketed drugs. The top line beat the Zacks Consensus Estimate of $87.3 million, as well as management's own guidance of $86-$88 million for the quarter.

IOVA's Product Sales Drive Revenue BeatIovance 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 $90.7 million from Amtagvi sales during the second quarter, up 68% year over year and 51% sequentially.  The figure surpassed both the Zacks Consensus Estimate and our model estimate of $79 million. Amtagvi also outperformed the company's forecast of $79-$81 million.

Proleukin sales rose 46% to $8.6 million, benefitting from its use alongside Amtagvi. The reported sales marginally beat the Zacks Consensus Estimate and our model estimate of $8.5 million. Management attributed the sequential decline from roughly $11 million in the previous quarter to the timing of wholesaler inventory stocking.

Shares of Iovance jumped 43% yesterday to a 52-week high following the results, likely reflecting an encouraging investor response to Amtagvi's commercial momentum. Though the company did not immediately raise its revenue outlook, management said it is reviewing the guidance and will provide an update during the third quarter amid strong demand trends.

Year to date, the stock has skyrocketed 127.5% compared with the industry’s 3.5% growth.

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IOVA Expands Margin While Controlling CostsGross margin improved to 56% from 41% in the first quarter of 2026, marking a quarterly high. Higher Amtagvi volume, continued cost optimization and efficiencies from fully in-house manufacturing supported the improvement.

Research and development expenses declined 24% year over year to $58.9 million. Selling, general and administrative expenses increased 5% to $39.3 million.

Iovance ended the second quarter with approximately $304 million in cash and cash equivalents compared with $319 million in the previous quarter. Management expects the current cash position to fund operations into the second half of 2028, compared with its previous expectation of funding operations into 2028.

The longer runway comes as Iovance continues to improve manufacturing efficiencies and control operating expenses while advancing its commercial launch and pipeline.

IOVA Reviews Full-Year Revenue OutlookStrong second-quarter sales prompted management to review its previously issued 2026 total revenue guidance of $350-$370 million. Iovance plans to provide an updated forecast during the third quarter after assessing current demand trends.

Management expects Amtagvi's demand to increase in both the third and fourth quarters. Proleukin sales are also expected to grow alongside Amtagvi, with the product anticipated to represent approximately 16% of total revenues on a steady-state basis during the remainder of the year.

Updates on IOVA’s Pipeline & Other NewsAmtagvi recently secured approval in Australia for the melanoma indication. In the U.K., a regulatory filing for the therapy was resubmitted last month and is undergoing expedited review for potential approval before this year’s end. While a potential approval for Amtagvi in Switzerland is expected in the first half of 2027, Iovance is in discussions with the EMA to resubmit a regulatory filing for the therapy next year.

Iovance continues to advance its development programs for Amtagvi. It is evaluating the drug in combination with Merck’s (MRK - Free Report) 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 the earnings results, the company reported that enrolment is nearly complete in the pivotal cohorts of the phase II IOV-LUN-202 study evaluating the therapy for previously treated metastatic non-squamous non-small cell lung cancer (NSCLC). An update is expected in the fourth quarter of 2026. The company intends to submit a regulatory filing seeking label expansion in 2027.

Amtagvi is being evaluated in separate mid-stage studies for endometrial cancer and soft tissue sarcomas.

IOVA’s Zacks RankIovance currently carries a Zacks Rank #2 (Buy).

Other Key Picks Among Biotech StocksSome other top-ranked stocks in the biotech sector are Harmony Biosciences (HRMY - Free Report) and Liquidia Corporation (LQDA - 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, earnings per share (EPS) estimates for Harmony Biosciences have risen from $3.20 to $3.33 for 2026. Over the same period, EPS estimates have increased from $3.64 to $3.87 for 2027. HRMY shares have risen about 4% year to date.

Harmony Biosciences missed earnings in three of the trailing four quarters while meeting on one occasion, delivering an average negative surprise of 13.97%.

Over the past 60 days, estimates for Liquidia’s 2026 EPS have increased to $3.02 from $2.97. Over the same period, EPS estimates for 2027 have risen from $4.81 to $5.31. LQDA shares have skyrocketed 159% so far this year.

Liquidia’s earnings beat estimates in three of the trailing four quarters and missed on one occasion, with the average surprise being 54.40%.

Iovance Biotherapeutics, Inc. (IOVA) Q2 2026 Earnings Call Transcript

Iovance Biotherapeutics (IOVA - Free Report) came out with a quarterly loss of $0.11 per share versus the Zacks Consensus Estimate of a loss of $0.17. This compares to a loss of $0.33 per share a year ago. These figures are adjusted for non-recurring items.

This quarterly report represents an earnings surprise of +35.29%. A quarter ago, it was expected that this biotechnology company would post a loss of $0.19 per share when it actually produced a loss of $0.19, delivering no surprise.

Over the last four quarters, the company has surpassed consensus EPS estimates three times.

Iovance Biotherapeutics, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $99.31 million for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 13.73%. This compares to year-ago revenues of $59.95 million. The company has topped consensus revenue estimates two times 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 59% since the beginning of the year versus the S&P 500's gain of 12.8%.

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 favorable. 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 #2 (Buy) for the stock. So, the shares are expected to outperform 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 -$0.15 on $93.41 million in revenues for the coming quarter and -$0.60 on $359.12 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 top 44% 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.

One other stock from the same industry, ADC Therapeutics SA (ADCT - Free Report) , is yet to report results for the quarter ended June 2026.

This company is expected to post quarterly loss of $0.19 per share in its upcoming report, which represents a year-over-year change of +62%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days.

ADC Therapeutics SA's revenues are expected to be $20.15 million, up 7% from the year-ago quarter.

SAN CARLOS, Calif., July 30, 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, August 6, 2026 at 8:30 a.m.

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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.

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.

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 (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.

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, Inc. (IOVA) Q1 2026 Earnings Call Transcript

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%.

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.

CONTACTS

Investors
[email protected]
650-260-7120 ext. 150

Media
[email protected]
650-260-7120 ext. 150

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.

CONTACTS 

Investors
[email protected]
650-260-7120 ext. 150

Media
[email protected] 
650-260-7120 ext. 150

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.

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.

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