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62.5% Confirmed Objective Response Rate (ORR) and 29.2% Complete Response (CR) Rate in Final Phase 2 Analysis

Median Overall Survival (OS) Not Reached at More than 4 Years of Median Follow-up

Oral Presentation at the European Society for Medical Oncology (ESMO) Congress 2026 Reinforces Ongoing TILVANCE-301 Phase 3 Trial

PHILADELPHIA and MADRID, Oct. 23, 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 one-time lifileucel combined with pembrolizumab demonstrated a 62.5% ORR and a 29.2% CR rate, with median OS not reached at 50.9 months of median study follow-up in the final Phase 2 analysis in frontline advanced melanoma. The Phase 2 results were presented on October 23, 2026 in a Proffered Paper oral session at the ESMO Congress 2026 in Madrid, Spain.

In frontline advanced melanoma, approximately half of patients treated with combination immune checkpoint inhibitor (ICI) therapy do not achieve long-term benefit, a widely recognized unmet need.1 Following successful adoption of lifileucel in the post-anti-PD-1 therapy setting, this Phase 2 data supports the earlier use and potential approval of lifileucel plus pembrolizumab in frontline advanced melanoma. Iovance estimates that 70,000 patients with frontline advanced melanoma are addressable each year in global markets with high prevalence.2

ESMO Presentation Highlights: Cohort 1A of the IOV-COM-202 Trial (NCT03645928)

IOV-COM-202 is a multicohort, multicenter Phase 2 trial of lifileucel plus pembrolizumab in patients with solid tumors. The final analysis in frontline advanced melanoma (Cohort 1A) included 24 patients treated with one-time lifileucel that met pre-determined manufacturing specifications and pembrolizumab monotherapy for up to 24 months.

The physician-assessed confirmed ORR by RECIST v1.1 was 62.5% (15/24; 95% CI: 40.6, 81.2), including a 29.2% CR rate. The disease control rate was 83.3% (20/24; 95% CI: 62.6, 95.3). Median duration of response (DOR) was not reached (range: 4.3 to 57.7+ months) at a median follow-up of 26.9 months for DOR.

Median progression-free survival (PFS) was 19.8 months (95% CI: 3.6 months to not reached). Median PFS after second line of therapy was 34.3 months (95% CI: 6.8 months to not reached), indicating that subsequent systemic therapy remains feasible after frontline lifileucel and pembrolizumab, including additional ICI therapy. Median OS was not reached (95% CI: 19.2 months to not reached) at a median study follow-up of 50.9 months.

Safety was consistent with the underlying disease and known safety profiles of one-time lifileucel and pembrolizumab. Late adverse events were consistent with continuous use of pembrolizumab monotherapy, further differentiating lifileucel plus pembrolizumab from ICI combinations used in the frontline setting.

“About half of patients do not experience lasting benefit with frontline combination immunotherapy for advanced melanoma,” stated Dr. Andrew J.S. Furness, Consultant Medical Oncologist and Solid Tumour Cellular Therapy Lead at The Royal Marsden National Health Service Foundation Trust, Leader of the Cellular Therapy and Translational Immunology Group at The Institute of Cancer Research, London, and Principal Investigator in IOV-COM-202 and TILVANCE-301 trials. “A single administration of lifileucel plus pembrolizumab demonstrated compelling response rates and durability that compare favorably to other ICI combination approaches in frontline advanced melanoma, with median overall survival not reached at more than four years of follow-up. These remarkable Phase 2 results provide a strong scientific rationale to investigate earlier treatment with lifileucel in the TILVANCE-301 trial.”

Translational analyses support the positive clinical results in Cohort 1A. T-cell receptor (TCR) sequencing detected clones from the infused lifileucel product in the peripheral blood for as long as 12 months after infusion (n=13), consistent with the strong DOR benefit of lifileucel.

Noah Berkowitz, M.D., Ph.D., Chief Medical Officer of Iovance, stated, “The final Cohort 1A results demonstrate unprecedented efficacy and a potentially best-in-class clinical profile for lifileucel combined with pembrolizumab in frontline advanced melanoma. These data, together with supportive translational findings, reinforce the importance of our ongoing TILVANCE-301 Phase 3 randomized trial to support a new approval for lifileucel in frontline advanced melanoma.”

The presentation is available at www.iovance.com. Iovance will also present the first clinical data for lifileucel in soft tissue sarcomas in a Rapid Oral presentation on Monday, October 26, 2026 (Abstract #3725RO).

About TILVANCE

TILVANCE-301 (NCT05727904) is a Phase 3, multicenter, open-label, randomized, parallel group, treatment study to assess the efficacy and safety of lifileucel in combination with pembrolizumab compared with pembrolizumab alone in participants with untreated, unresectable or metastatic melanoma. The trial is enrolling at more than 80 sites in the U.S., Canada, Europe, and Asia-Pacific. The dual primary endpoints are ORR and PFS assessed by independent review committee. TILVANCE-301 is designed to support approval for lifileucel in combination with pembrolizumab in frontline advanced melanoma and to serve as the confirmatory trial for full U.S. approval of Amtagvi® in previously treated advanced melanoma.

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 nearly 100 authorized treatment centers (ATCs). 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. Headquartered in Pennsylvania with offices and laboratories in California and Florida, Iovance serves patients at ATCs and clinical sites across almost the entire U.S. and in many countries around the world. 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.

About the ESMO Congress

The ESMO Congress is organized by the European Society for Medical Oncology (ESMO) and is one of the world’s most influential annual oncology meetings, bringing together more than 37,000 clinicians, researchers, patient advocates, and industry representatives from around the world. The ESMO Congress 2026 takes place October 23–27, 2026, at IFEMA Madrid, Spain, and features presentations of practice-changing clinical data, translational science, and educational programming across all major tumor types. For more information, visit www.esmo.org.

References

Larkin J, et al. N Engl J Med. 2019;381:1535-46.SEER and GLOBOCAN epidemiology data and internal data on file. 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 size of the addressable patient populations for, and 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 iCTC facility, including the risk that our ability to increase manufacturing capacity at our facility may adversely affect our commercial supply or clinical supply; the risks related to our ability to obtain, maintain and enforce patent and other intellectual property protection for our products and product candidates; 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 clinical studies and cohorts, and meetings with regulatory authorities, may support registrational studies and subsequent approvals by regulatory authorities, including the risk that our registrational trials, including TILVANCE-301, may be delayed, may not meet their primary endpoints, or may not support approval; clinical results, whether preliminary, interim, or final, which may include efficacy and safety results, from 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 or future trials or cohorts, including the risk that the Cohort 1A results of IOV-COM-202 may not be predictive of results in the ongoing TILVANCE-301 trial; 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 or others; 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 ATCs, 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.

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Iovance Advances TIL Cell Therapy into a New Chapter in Solid Tumor Treatment

Two Oral Presentations to Showcase Deep, Durable Responses with TIL Cell Therapy in Frontline Melanoma and Previously Treated Soft Tissue Sarcomas

PHILADELPHIA, Oct. 19, 2026 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) cell therapies for patients with cancer, will present five abstracts from its TIL platform at the European Society for Medical Oncology (ESMO) Congress 2026, including two oral presentations of new clinical data in previously untreated advanced melanoma and, for the first time, in two soft tissue sarcomas. The congress takes place October 23–27, 2026, in Madrid, Spain.

The oral presentation of results with lifileucel in two previously treated soft tissue sarcomas, undifferentiated pleomorphic sarcoma (UPS) and dedifferentiated liposarcoma (DDLPS), are from a pilot clinical trial led by Memorial Sloan Kettering Cancer Center (MSKCC) and supported by Iovance. Soft tissue sarcomas are rare and highly heterogeneous cancers comprising approximately 80 tumor subtypes, with an estimated incidence of 4–5 cases per 100,000 people annually in Europe and ~3.5 new diagnoses per 100,000 people in the United States each year.1, 2 For patients with advanced UPS and DDLPS who progress following standard therapies, treatment options remain limited and prognosis is often poor, highlighting the need for new approaches that can deliver meaningful and durable responses.

“This is our first congress presentation of TIL cell therapy in two soft tissue sarcomas with significant unmet need,” said Noah Berkowitz, M.D., Ph.D., Chief Medical Officer of Iovance. “The efficacy and durability observed in this early cohort are what moved us quickly toward our ongoing SARATOGA registrational trial of lifileucel in UPS and DDLPS. This is the broadest look yet at how Iovance’s growing TIL platform performs across solid tumors.”

A second oral presentation, as a proffered paper, highlights the final Phase 2 results for lifileucel in combination with pembrolizumab in patients with immune checkpoint inhibitor (ICI)-naive advanced melanoma. Additional posters will highlight emerging translational and real-world evidence, including an indirect comparison suggesting that lifileucel may approximately double four-year overall survival rates compared with standard-of-care therapies in anti-PD-1-resistant advanced melanoma. Together, these data continue to expand the evidence base for Iovance’s TIL platform.

“Our Phase 2 results in frontline, advanced melanoma show deep, durable responses with a single treatment of lifileucel added to pembrolizumab,” Berkowitz continued. “These data reinforce the scientific rationale behind TILVANCE-301, our Phase 3 trial evaluating lifileucel earlier in the treatment of advanced melanoma, highlighting the opportunity this approach may offer patients who don’t achieve lasting benefit from today’s frontline treatments.”

Oral Presentations

Proffered Paper (Abstract #2072O): Efficacy and Safety of Lifileucel and Pembrolizumab in Patients with Immune Checkpoint Inhibitor-Naïve Advanced Melanoma: Final Results from IOV-COM-202 Study
Authors: Andrew J.S. Furness, et al.
Session: Friday, October 23, 2026, 16:15–17:45 CEST Rapid Oral (Abstract #3725RO): Lifileucel in Patients with Undifferentiated Pleomorphic Sarcoma (UPS) or Dedifferentiated Liposarcoma (DDLS)
Authors: Lauren Banks, et al.
Session: Monday, October 26, 2026, 08:30–10:00 CEST Poster Presentations

Poster (Abstract #4359P): Enrichment of Putative Tumor-Reactive Clones in NSCLC Patients Responding to Lifileucel: Temporal Single Cell Analysis from a Clinical Trial 
Authors: Martin Wermke, et al.
Session: Friday, October 23, 2026, 15:15–16:00 CEST Poster (Abstract #2117P): Indirect Comparison of Overall Survival (OS) between Lifileucel versus Standard-of-Care (SoC) in US Real-World Settings in Anti-PD-1 Resistant Advanced Melanoma 
Authors: Barbara Ma, et al.
Session: Saturday, October 24, 2026, 12:00–12:45 CEST Poster (Abstract #2125P): Lifileucel versus Nivolumab plus Relatlimab (NIVO+RELA) in Anti–PD-(L)1-Resistant Advanced Melanoma: A Match-Adjusted Indirect Comparison (MAIC) of Efficacy Outcomes 
Authors: Gino K. In, et al.
Session: Saturday, October 24, 2026, 12:00–12:45 CEST The ESMO Congress 2026 scientific program and abstracts are available at https://www.esmo.org/meeting-calendar/esmo-congress-2026. Presentations will be available following the conclusion of each session on www.iovance.com and the ESMO Congress virtual platform.

About SARATOGA

SARATOGA (NCT07741877) is a registrational Phase 2 clinical trial evaluating the safety and efficacy of lifileucel in patients with advanced (metastatic or unresectable) undifferentiated pleomorphic sarcoma (UPS) or dedifferentiated liposarcoma (DDLPS) who were refractory to at least one prior line of systemic therapy. UPS and DDLPS are high-grade, aggressive soft tissue sarcomas associated with poor prognosis and limited treatment options for patients who progress on chemotherapy.

About TILVANCE

TILVANCE-301 (NCT05727904) is a Phase 3, multicenter, open-label, randomized, parallel group, treatment study to assess the efficacy and safety of lifileucel in combination with pembrolizumab compared with pembrolizumab alone in participants with untreated, unresectable or metastatic melanoma.

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 nearly 100 authorized treatment centers (ATCs). 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. Headquartered in Pennsylvania with offices and laboratories in California and Florida, Iovance serves patients at ATCs and clinical sites across almost the entire U.S. and in many countries around the world. 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.

About the ESMO Congress

The ESMO Congress is organized by the European Society for Medical Oncology (ESMO) and is one of the world’s most influential annual oncology meetings, bringing together more than 37,000 clinicians, researchers, patient advocates, and industry representatives from around the world. The ESMO Congress 2026 takes place October 23–27, 2026, at IFEMA Madrid, Spain, and features presentations of practice-changing clinical data, translational science, and educational programming across all major tumor types. For more information, visit www.esmo.org.

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.

References

1. Gronchi A, et al. Soft tissue and visceral sarcomas: ESMO-EURACAN-GENTURIS Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2021;32(11):1348-1365. doi:10.1016/j.annonc.2021.07.006.

2. National Cancer Institute Surveillance, Epidemiology and End Results (SEER) Program. 2026 Estimates. Cancer Stat Facts: Soft Tissue including Heart Cancer https://seer.cancer.gov/statfacts/html/soft.html . Accessed October 13, 2026.

Contacts

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 | Source: Iovance Biotherapeutics, Inc.

PHILADELPHIA, Oct. 16, 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 October 15, 2026 (the “Date of Grant”), the Company approved the grant of inducement stock options covering an aggregate of 111,615 shares of Iovance’s common stock to twenty-one 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 $14.72, 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. 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 nearly 100 authorized treatment centers (ATCs). 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. Headquartered in Pennsylvania with offices and laboratories in California and Florida, Iovance serves patients at ATCs and clinical sites across almost the entire U.S. and in many countries around the world. 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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Key Takeaways Iovance raised its 2026 revenue outlook to $410-$420 million, up from $350-$370 million.Strong patient demand for Amtagvi and Proleukin is driving the higher 2026 revenue expectations.Rising demand and manufacturing visibility support revenue expectations for the third and fourth quarters. Shares of Iovance Biotherapeutics (IOVA - Free Report) touched a 52-week high yesterday after the company raised its full-year 2026 total revenue guidance. The stock is currently trading at $14.45.

Iovance now expects total revenues of $410-$420 million, up from the previous guidance of $350-$370 million in 2026. The midpoint of the new range reflects an increase of $55 million, or approximately 15%, from the prior outlook.

IOVA stock surged 31.5% yesterday following the announcement of the news.

The raised outlook reflects strong demand for IOVA’s marketed therapies Amtagvi (lifileucel) and Proleukin in the United States. Per management, increasing patient demand, along with its current manufacturing schedule, provides visibility into revenues for the third and fourth quarters of 2026.

The company plans to report its third-quarter 2026 results in early November.

IOVA Price PerformanceYear to date, shares of Iovance have skyrocketed 429.3% compared with the industry’s rise of 8.9%.

Image Source: Zacks Investment Research

Amtagvi Drives IOVA’s Top-Line GrowthIovance has established its position in tumor-infiltrating lymphocyte (TIL) therapy for solid tumors. The company’s lead marketed product, Amtagvi, is the first FDA-approved one-time T-cell therapy treatment for people with previously treated melanoma that has spread or cannot be removed by surgery.

Amtagvi recorded $151 million in sales in the first half of 2026, increasing around 54% year over year, backed by underlying organic demand. Management expects demand to continue rising through the remainder of 2026.

Amtagvi’s commercial uptake has been encouraging since launch and its demand is also rising. Iovance has approximately 100 authorized treatment centers (ATCs) across various countries and expects expansion to at least 110 ATCs by the end of 2026.

Iovance is also evaluating Amtagvi across several additional solid tumors, including non-small cell lung cancer (NSCLC), where management estimates the targeted U.S. opportunity at about seven times the size of advanced melanoma.

Proleukin is approved to treat metastatic renal cell carcinoma and metastatic melanoma in adults.

Amtagvi demand is also supporting Proleukin sales, as the drug forms part of the treatment regimen. Management expects Proleukin revenues to grow during the remainder of 2026, in line with increasing Amtagvi utilization.

IOVA’s Zacks Rank & Stocks to ConsiderIovance currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the biotech sector are AC Immune (ACIU - Free Report) and Precigen (PGEN - Free Report) , both sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

Over the past 60 days, the Zacks Consensus Estimate for AC Immune’s 2026 loss per share has narrowed from 84 cents to 60 cents. Over the same period, earnings estimates for 2027 have remained unchanged at 17 cents per share. ACIU shares have lost 17.2% year to date.

AC Immune’s earnings beat Zacks Consensus Estimate in each of the trailing four quarters, with the average surprise being 33.25%.

Over the past 60 days, estimates for Precigen’s 2026 bottom line have moved from a loss of 2 cents to earnings of 24 cents. Earnings estimates for 2027 have increased from 25 cents to 73 cents per share during the same time. PGEN’s shares have rallied 92.6% year to date.

Precigen’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 108.96%.

Iovance Biotherapeutics, Inc. (NASDAQ:IOVA) shares are trading higher on Tuesday as the company raises full-year 2026 revenue guidance, bucking a -0.8% slide in the Healthcare sector even as the S&P 500 is down 0.10%.

The move reads as company-specific strength rather than a broad risk-on tape, with market breadth only modestly positive (advance/decline ratio 1.2).

IOVA Raises 2026 Revenue Guidance On Amtagvi DemandIovance lifted full-year 2026 revenue guidance to $410 million to $420 million, $55 million higher at the midpoint versus the prior $350 million to $370 million range.

The company pointed to strong U.S. demand for Amtagvi (lifileucel) and Proleukin as the driver behind the higher outlook.

“Increasing patient demand and our current manufacturing schedule provide strong visibility into our third and fourth quarter revenues. In addition, lifileucel continues to advance across our registrational programs in new solid tumor indications, while continued manufacturing and operating efficiencies accelerate our progress toward profitability,” said Frederick Vogt, Interim President & CEO.

IOVA Technical Analysis: Breakout Momentum And Key LevelsTechnically, the stock is in a momentum breakout posture: at $13.45 it’s above the prior 52-week high of $11.16, which often forces shorts and under-positioned longs to chase.

It’s also stretched well above trend gauges—about 42.5% above the 20-day SMA ($9.74) and roughly 79.9% above the 50-day SMA ($7.71)—so follow-through matters more than "cheap" entries here.

RSI is the cleanest momentum lens right now, and at 85.09 it’s firmly overbought, signaling the move is extended and more prone to sharp pullbacks or sideways digestion.

The longer-term trend is still constructive, with the 20-day SMA above the 50-day SMA and a golden cross (50-day above 200-day) that occurred in January, but the near-term risk is that any disappointment can unwind quickly from these stretched levels.

Key Resistance: $13.45 — price is pressing fresh highs above the prior 52-week peak zone, making this the immediate "air pocket" area to watch Key Support: $9.74 — aligns with the 20-day SMA, a common first pullback area in strong uptrends. Analyst Consensus & Recent Actions: The stock carries a Buy rating with an average price forecast of $11.43. Recent analyst moves include:

Goldman Sachs: Buy (Price Forecast $15) (September 24) Barclays: Overweight (Raises Price Forecast to $15) (September 17) TD Cowen: Buy (Raises Price Forecast to $10) (August 25) How IOVA Ranks On Momentum And Other FactorsBelow is the Benzinga Edge scorecard for Iovance Biotherapeutics, highlighting its strengths and weaknesses compared to the broader market:

Momentum: Bullish (Score: 99.65) — The stock is showing extreme relative strength, consistent with a breakout-style tape. The Verdict: Iovance Biotherapeutics’ Benzinga Edge signal reveals a momentum-driven story, with price action doing most of the talking right now.

With momentum this elevated, the main tactical risk is volatility—strong trends can persist, but pullbacks can be fast when positioning gets crowded.

IOVA Price Action: Iovance Biotherapeutics shares were up 34.62% at $14.79 at the time of publication on Tuesday. The stock is trading at a new 52-week high, according to Benzinga Pro data.

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© 2026 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

A new, bullish analyst take on Iovance Biotherapeutics (IOVA +5.99%) put the company's shares in the win column on Thursday. That analysis was published by an always-influential investment bank, and it improved sentiment on Iovance sufficiently to send the shares to an almost 6% gain.

It's golden with Goldman That morning Goldman Sachs, in the person of pundit Andrea Newkirk, resumed coverage of Iovance, a biotech that concentrates on developing cancer therapies. She rated Iovance's equity a buy at a price target of $15 per share.

Image source: Getty Images.

According to reports, Newkirk cited the company's second-quarter performance as a key reason for her optimistic analysis. Iovance's sole commercialized drug, Amtagvi, generated $91 million in sales and treated 150 patients. In her view, the medicine is now at the start of a potentially significant up cycle, as operational roadblocks like availability are starting to be removed.

The analyst also cited a proprietary survey indicating that interest and demand for Amtagvi as a second-line treatment for melanoma -- for which it received Food and Drug Administration (FDA) approval -- was strong, portending well for its success.

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Significant potential Iovance received that green light for Amtagvi in early 2024, so the road to commercialization has been long and at times difficult. I find Newkirk's view that the drug has reached something of an inflection point to be realistic and believable; to me, it is gathering real momentum these days. I think the analyst and the investors who bought into Iovance on Thursday are on to something.

Eric Volkman has no position in any of the stocks mentioned. The Motley Fool has positions in and recommends Goldman Sachs Group and Iovance Biotherapeutics. The Motley Fool has a disclosure policy.

Why 2 Small Biotechs May Hold the Key to New Cancer TreatmentsIovance Biotherapeutics NASDAQ: IOVA said it is expanding its tumor-infiltrating lymphocyte, or TIL, therapy platform across multiple solid-tumor indications after reporting a record second quarter marked by nearly $100 million in revenue and a 56% margin.

Speaking at the H.C. Wainwright 28th Annual Global Investment Conference, Brian Gastman, Iovance’s executive vice president of translational medicine and research, said the company has moved TIL therapy from academic research into commercial use. He said Iovance has treated more than 2,000 patients clinically and commercially and has two approved and commercialized therapies: Amtagvi, its flagship TIL therapy, and Proleukin, also known as interleukin-2.

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3 Biotech Stocks to Watch: Iovance, Neurocrine & VikingGastman said the company’s cash runway exceeds $300 million and extends into mid-2028, providing what he described as a “clear line of sight to profitability.”

TIL Manufacturing and Market Access TIL therapy is a one-time, patient-specific treatment made from immune cells collected from a patient’s tumor. The cells are expanded into the billions and then returned to the same patient after preparatory treatment, Gastman said.

The Top 5 Analysts Ranked by MarketBeat and Stocks They CoverIovance manufactures the therapy at its Iovance Cell Therapy Center in Philadelphia. The facility supports clinical and commercial supply and has modular capacity for more than 5,000 patients, according to Gastman. He said the facility is a strategic asset for controlling supply, expanding margins and creating operating leverage as treatment volumes increase.

The company has more than 95 authorized treatment centers, including roughly one-third in community settings, and expects to reach 110 centers by year-end. Gastman said more than 95% of U.S. patients are within 200 miles of a treatment center, while more than 80% are within 100 miles.

He also said Iovance has payer policies covering more than 250 million lives, including Medicare and commercial coverage, representing more than 75% of the U.S. population.

Melanoma Program and Frontline Trial Gastman said the data supporting Amtagvi’s FDA approval, as well as approvals in Canada and Australia, showed durable responses in heavily pretreated melanoma patients. In an analysis of four experienced treatment centers, Iovance reported a 44% response rate, with response rates above 50% among patients treated in the second-line setting, he said.

The company is also studying TIL therapy earlier in advanced melanoma. In the IOV-COM-202 Cohort 1A trial, Amtagvi combined with pembrolizumab in immune checkpoint inhibitor-naïve patients produced response rates in the mid-60% range and a 30% complete-response rate at the time of analysis, according to Gastman.

Gastman said more mature data from the study are scheduled for an oral presentation at the European Society for Medical Oncology meeting. The regimen is also the experimental arm in Iovance’s international Phase III TILVANCE-301 confirmatory trial, which is intended to support confirmation of the company’s second-line accelerated approval and potentially support frontline approval.

Pipeline Targets Lung Cancer, Sarcoma and Endometrial Cancer Iovance is advancing its standard TIL platform in non-small cell lung cancer, soft-tissue sarcoma and endometrial cancer. For non-squamous non-small cell lung cancer without EGFR, ROS or ALK alterations, Gastman said the company has previously reported a response rate of nearly 26%. With more than two years of follow-up, median duration of response had not been reached, he said.

The company expects to complete the lung cancer trial soon and present a larger data set by the end of the year, with a supplemental biologics license application planned for 2027. The program has received Fast Track designation from the FDA.

In soft-tissue sarcoma, Iovance is studying TIL therapy in undifferentiated pleomorphic sarcoma and dedifferentiated liposarcoma. Gastman said an initial patient group showed a 50% response rate, with all responses ongoing and, in some cases, deepening. The program has progressed into a registrational trial called SARATOGA.

For advanced endometrial cancer, the company identified a signal in serous endometrial carcinoma. Gastman said TIL therapy produced a 40% response rate and 100% disease-control rate in the studied population. Iovance is engaging with the FDA and evaluating potential expedited development pathways, he said.

Next-Generation Programs Iovance is also developing genetically modified TIL therapies and an engineered interleukin-2 program. IOV-4001 is a PD-1-inactivated TIL therapy that has been tested in melanoma and has moved into non-small cell lung cancer.

The company’s IOV-5001 program is designed to express IL-12 at the cell surface within the tumor microenvironment, an approach intended to limit broader systemic exposure. Gastman said Iovance plans to evaluate the therapy in tumors that have historically been more difficult for TIL therapy, including colorectal cancer, triple-negative breast cancer and head and neck cancer.

Its IOV-3001 engineered IL-2 program is currently in dose escalation, with additional information expected soon, Gastman said.

About Iovance Biotherapeutics (NASDAQ:IOVA)Iovance Biotherapeutics, Inc is a biotechnology company focused on developing and commercializing individualized cell therapies for patients with cancer. Its platform uses tumor-infiltrating lymphocytes (TILs), immune cells collected from a patient's tumor, expanded in a manufacturing facility and returned to the patient to help recognize and attack cancer cells.

The company's lead product, Amtagvi (lifileucel), is an autologous TIL therapy approved by the U.S. Food and Drug Administration for certain adults with unresectable or metastatic melanoma that has progressed following prior treatment.

This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected].

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Key Takeaways ABVX's late-stage obefazimod program in ulcerative colitis could draw interest from larger drugmakers.IOVA's growing Amtagvi sales, broader TIL pipeline and in-house manufacturing boost its M&A appeal.BCRX's growing HAE franchise and VKTX's scarce late-stage obesity asset could draw buyer interest. M&A activity in the biotech sector has accelerated sharply in 2026, as large drugmakers increasingly turn to external innovation to strengthen pipelines, expand into new therapeutic areas and gain access to promising technologies and late-stage assets. For some companies, looming patent expirations are also adding urgency to the search for new growth drivers.

Per IQVIA, deal value reached roughly $130 billion in the first half of 2026 alone, nearly matching the $133 billion recorded for all of 2025. Eli Lilly (LLY - Free Report) has been particularly aggressive, announcing about 10 acquisitions so far this year as it expands beyond its core diabetes and obesity franchises into areas such as immunology, oncology, neuroscience and vaccines. Gilead, GSK and Novartis have also remained active on the M&A front.

The current M&A cycle has largely favored targeted mid-sized and bolt-on acquisitions rather than transformative mega-mergers, allowing Big Pharma to add promising products, platforms or capabilities that complement existing portfolios. At the same time, drugmakers are navigating pricing pressure from the Inflation Reduction Act (IRA) and the Trump administration’s push for Most-Favored-Nation (MFN) pricing. These dynamics could further increase the strategic value of biotech companies with differentiated commercial or late-stage assets capable of supporting future growth.

In this article, we highlight four biotech stocks — Abivax (ABVX - Free Report) , Iovance Biotherapeutics (IOVA - Free Report) , Viking Therapeutics (VKTX - Free Report) and BioCryst Pharmaceuticals (BCRX - Free Report) . These companies could attract acquisition interest given their differentiated commercial or late-stage assets and exposure to strategically important therapeutic areas. While Abivax and Iovance each carry a Zacks Rank #2 (Buy), Viking and BioCryst currently have a Zacks Rank #3 (Hold).

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

ABVX: Late-Stage Immunology Asset Puts It on M&A RadarAbivax could attract larger drugmakers looking to strengthen their immunology and inflammation portfolios. Its lead candidate is obefazimod, an oral first-in-class miR-124 enhancer being developed for moderately to severely active ulcerative colitis (UC). The drug delivered positive results in both phase III induction studies, ABTECT-1 and ABTECT-2, followed by encouraging results from the phase III ABTECT maintenance study. Based on the overall phase III data, Abivax plans to submit a regulatory filing to the FDA for obefazimod by the end of 2026.

The opportunity could extend beyond UC. Abivax is also evaluating obefazimod in Crohn's disease through the phase IIb ENHANCE-CD study, with induction data expected in mid-2027. This could give a potential acquirer access to a differentiated oral therapy across two major inflammatory bowel disease (IBD) markets. Abivax is also evaluating obefazimod in combination with other mechanisms and developing follow-on miR-124 enhancers, potentially broadening the platform’s longer-term value beyond the lead program.

Abivax has already attracted considerable takeover speculation, with some third-party reports linking Eli Lilly to potential acquisition interest. However, management dismissed the takeover reports, and no acquisition discussions have been confirmed. With obefazimod approaching a potential regulatory filing and offering expansion opportunities beyond UC, Abivax remains a notable name on biotech M&A watchlists.

IOVA: Amtagvi & TIL Pipeline Strengthen M&A AppealIovance could attract larger oncology players given its established position in tumor-infiltrating lymphocyte (TIL) therapy for solid tumors. The company’s lead marketed product is Amtagvi, the first FDA-approved one-time T-cell therapy treatment for people with previously treated melanoma that has spread or cannot be removed by surgery. Commercial uptake has been encouraging since launch, with Amtagvi generating about $220 million in sales in 2025, its first full year on the market, and another $151 million in the first half of 2026. Per management, the recent increase reflects organic demand rather than shipment timing. It expects demand to continue rising through the remainder of 2026.

The appeal extends beyond Amtagvi’s current melanoma indication. Iovance is evaluating the therapy across several additional solid tumors, including non-small cell lung cancer (NSCLC), where management estimates the targeted U.S. opportunity at about seven times the size of advanced melanoma. The company is also advancing next-generation TIL therapies, giving a potential buyer access to a broader cell-therapy platform.

An acquirer would additionally gain Iovance’s specialized in-house manufacturing capabilities, an important asset in the operationally complex cell-therapy space. With an approved and growing product, opportunities for label expansion and a broader TIL pipeline, Iovance could represent an attractive strategic fit for a larger oncology-focused drugmaker.

VKTX: A Scarce Late-Stage Obesity AssetViking Therapeutics could attract larger drugmakers looking to strengthen their presence in the fast-growing obesity market. The company is one of the relatively few independent biotechs with a late-stage obesity candidate. Its lead candidate, VK2735, is a dual GLP-1/GIP receptor agonist being developed in both injectable and oral formulations. While the injectable version is already being evaluated in two phase III studies, late-stage development on oral VK2735 is expected to begin in fourth-quarter 2026. The nearest catalyst is data from a maintenance-dosing study evaluating whether weight loss achieved with weekly injectable VK2735 can be sustained using less-frequent injectable or oral dosing. Subcutaneous maintenance data are expected in the third quarter of 2026.

Viking recently broadened its obesity pipeline with VK3019, a dual amylin and calcitonin receptor agonist that entered phase I development this year. Beyond obesity, the company also has VK2809, which has completed a phase IIb study in NASH and shown encouraging efficacy. Viking is currently seeking partnership opportunities to further develop this program, which could add another element of strategic value for a potential buyer.

With no approved products or established commercial infrastructure, Viking could benefit from the resources of a larger drugmaker. In turn, an acquirer would gain a late-stage obesity franchise along with additional metabolic assets.

BCRX: Rare-Disease Franchise Offers Strategic ValueBioCryst Pharmaceuticals could attract larger drugmakers looking to strengthen their presence in rare diseases, particularly hereditary angioedema (HAE). The company already has an established commercial franchise in Orladeyo, a once-daily oral therapy approved for preventing HAE attacks. The drug generated $306.5 million in revenues during the first half of 2026, up 5% year over year. BioCryst expects full-year net sales of $625-$645 million, providing a potential acquirer with growing revenue stream.

BioCryst further strengthened its HAE portfolio through the acquisition of Astria Therapeutics earlier this year, which added late-stage candidate navenibart. The long-acting injectable therapy is being developed for dosing once every three or six months, potentially complementing Orladeyo by giving BioCryst both oral and injectable prophylactic options. Enrollment in the phase III ALPHA-ORBIT study has been completed, with the program expected to support a regulatory filing by the end of 2027.

The recently completed $10-billion acquisition of rare disease drugmaker Crinetics by Vertex has renewed takeover speculation around BioCryst. With an established commercial rare-disease product, a differentiated late-stage HAE candidate and existing commercialization infrastructure, BioCryst could offer a larger pharmaceutical company a relatively de-risked way to build or expand a rare-disease franchise.

Iovance Biotherapeutics (NASDAQ:IOVA – Get Free Report) and eXoZymes (NASDAQ:EXOZ – Get Free Report) are both healthcare companies, but which is the better stock? We will compare the two companies based on the strength of their earnings, risk, institutional ownership, profitability, dividends, analyst recommendations and valuation.

Analyst Recommendations This is a breakdown of current ratings and recommmendations for Iovance Biotherapeutics and eXoZymes, as provided by MarketBeat.com.

Sell Ratings Hold Ratings Buy Ratings Strong Buy Ratings Rating Score Iovance Biotherapeutics 2 2 7 0 2.45 eXoZymes 1 0 0 0 1.00 Iovance Biotherapeutics currently has a consensus price target of $8.89, suggesting a potential downside of 9.94%. Given Iovance Biotherapeutics’ stronger consensus rating and higher probable upside, research analysts plainly believe Iovance Biotherapeutics is more favorable than eXoZymes.

Profitability This table compares Iovance Biotherapeutics and eXoZymes’ net margins, return on equity and return on assets. Net Margins Return on Equity Return on Assets Iovance Biotherapeutics -89.11% -40.51% -31.65% eXoZymes N/A -292.15% -158.66% Risk & Volatility Iovance Biotherapeutics has a beta of 0.83, meaning that its share price is 17% less volatile than the S&P 500. Comparatively, eXoZymes has a beta of 3.14, meaning that its share price is 214% more volatile than the S&P 500.

Earnings and Valuation This table compares Iovance Biotherapeutics and eXoZymes”s revenue, earnings per share (EPS) and valuation.

Gross Revenue Price/Sales Ratio Net Income Earnings Per Share Price/Earnings Ratio Iovance Biotherapeutics $263.50 million 16.97 -$390.98 million ($0.73) -13.52 eXoZymes $70,000.00 816.64 -$9.16 million ($1.19) -5.18 eXoZymes has lower revenue, but higher earnings than Iovance Biotherapeutics. Iovance Biotherapeutics is trading at a lower price-to-earnings ratio than eXoZymes, indicating that it is currently the more affordable of the two stocks.

Institutional and Insider Ownership 77.0% of Iovance Biotherapeutics shares are held by institutional investors. 7.8% of Iovance Biotherapeutics shares are held by company insiders. Comparatively, 72.4% of eXoZymes shares are held by company insiders. Strong institutional ownership is an indication that hedge funds, endowments and large money managers believe a company is poised for long-term growth.

Summary Iovance Biotherapeutics beats eXoZymes on 8 of the 14 factors compared between the two stocks.

(Get Free Report)

Iovance Biotherapeutics, Inc., a commercial-stage biotechnology company, develops and commercializes cell therapies using autologous tumor infiltrating lymphocyte for the treatment of metastatic melanoma and other solid tumor cancers in the United States. The company offers Amtagvi, a tumor-derived autologous T cell immunotherapy used to treat adult patients with unresectable or metastatic melanoma; and Proleukin, an interleukin-2 product for the treatment of patients with metastatic renal cell carcinoma. It also develops lifileucel in combination with pembrolizumab to treat frontline advanced melanoma patients; LN-145 for the treatment of non-small cell lung cancer (NSCLC) and solid tumor cancers; IOV-4001, which is in Phase 1/2 IOV-GM1-201 clinical trial, for the treatment of NSCLC; and lifileucel for gynecological cancers. The company has collaborations and licensing agreements with WuXi Advanced Therapies, Inc.; National Institutes of Health; the National Cancer Institute; H. Lee Moffitt Cancer Center; The University of Texas M.D. Anderson Cancer Center; Cellectis S.A.; Novartis Pharma AG; and Boehringer Ingelheim Biopharmaceuticals GmbH. The company was formerly known as Lion Biotechnologies, Inc. and changed its name to Iovance Biotherapeutics, Inc. in June 2017. Iovance Biotherapeutics, Inc. was incorporated in 2007 and is headquartered in San Carlos, California.

About eXoZymes (Get Free Report)

eXoZymes, Inc. is a development stage synthetic biochemical company. Its synthetic biology platform would enable the scalable exploration of many molecules and properties found in nature. The company was founded by Tyler Korman and Paul Opgenorth in April 2019 and is headquartered in Monrovia, NV.

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Shares of Iovance Biotherapeutics, Inc. (NASDAQ:IOVA – Get Free Report) reached a new 52-week high during mid-day trading on Tuesday . The company traded as high as $9.41 and last traded at $9.26, with a volume of 21030162 shares. The stock had previously closed at $8.60.

Analysts Set New Price Targets A number of brokerages recently commented on IOVA. Barclays raised their target price on Iovance Biotherapeutics from $11.00 to $13.00 and gave the stock an “overweight” rating in a report on Friday, August 7th. Mizuho upped their target price on shares of Iovance Biotherapeutics from $10.00 to $11.00 and gave the stock an “outperform” rating in a research report on Tuesday, August 18th. UBS Group raised their price target on Iovance Biotherapeutics from $4.00 to $7.00 and gave the company a “neutral” rating in a report on Thursday, August 20th. Citizens Jmp lifted their price objective on shares of Iovance Biotherapeutics from $5.00 to $8.00 and gave the stock a “market outperform” rating in a research note on Friday, August 7th. Finally, Robert W. Baird set a $6.00 price objective on shares of Iovance Biotherapeutics in a research note on Friday, August 7th. Seven research analysts have rated the stock with a Buy rating, two have given a Hold rating and two have given a Sell rating to the company. According to MarketBeat.com, the stock currently has an average rating of “Hold” and a consensus price target of $8.89.

Read Our Latest Stock Analysis on Iovance Biotherapeutics

Iovance Biotherapeutics Price Performance The company has a market cap of $4.19 billion, a PE ratio of -12.68 and a beta of 0.83. The business has a fifty day simple moving average of $6.43 and a two-hundred day simple moving average of $4.78. Iovance Biotherapeutics (NASDAQ:IOVA – Get Free Report) last issued its quarterly earnings data on Thursday, August 6th. The biotechnology company reported ($0.11) earnings per share (EPS) for the quarter, topping analysts’ consensus estimates of ($0.13) by $0.02. The firm had revenue of $198.63 million for the quarter, compared to the consensus estimate of $87.83 million. Iovance Biotherapeutics had a negative net margin of 89.11% and a negative return on equity of 40.51%. The company’s quarterly revenue was up 65.7% compared to the same quarter last year. During the same quarter in the previous year, the firm earned ($0.33) EPS. On average, equities research analysts predict that Iovance Biotherapeutics, Inc. will post -0.49 EPS for the current year.

Institutional Inflows and Outflows A number of hedge funds have recently bought and sold shares of IOVA. BlackRock Inc. acquired a new stake in shares of Iovance Biotherapeutics during the 2nd quarter worth about $153,744,000. Invenomic Capital Management LP grew its holdings in shares of Iovance Biotherapeutics by 13.5% during the fourth quarter. Invenomic Capital Management LP now owns 11,959,505 shares of the biotechnology company’s stock worth $32,649,000 after buying an additional 1,417,897 shares in the last quarter. Palo Alto Investors LP acquired a new position in shares of Iovance Biotherapeutics in the second quarter valued at approximately $22,032,229. Bank of America Corp DE acquired a new position in shares of Iovance Biotherapeutics in the second quarter valued at approximately $20,773,000. Finally, Dimensional Fund Advisors LP lifted its stake in shares of Iovance Biotherapeutics by 71.9% during the first quarter. Dimensional Fund Advisors LP now owns 2,645,702 shares of the biotechnology company’s stock valued at $9,282,000 after buying an additional 1,106,592 shares during the period. Institutional investors and hedge funds own 77.03% of the company’s stock.

Iovance Biotherapeutics Company Profile (Get Free Report)

Iovance Biotherapeutics, Inc is a biotechnology company focused on developing and commercializing individualized cell therapies for patients with cancer. Its platform uses tumor-infiltrating lymphocytes (TILs), immune cells collected from a patient’s tumor, expanded in a manufacturing facility and returned to the patient to help recognize and attack cancer cells.

The company’s lead product, Amtagvi (lifileucel), is an autologous TIL therapy approved by the U.S. Food and Drug Administration for certain adults with unresectable or metastatic melanoma that has progressed following prior treatment.

Featured Articles Five stocks we like better than Iovance Biotherapeutics Analysts Are Punting Their Calls Into the Next Quarter After Adobe’s Mixed Earnings Institutional Money Is Pouring Into These 2 Altcoin ETFs The End of Big Tech Buybacks? Only One Hyperscaler Is Still Repurchasing Shares 3 Dividend Kings to Buy While They’re Still Beaten Down Receive News & Ratings for Iovance Biotherapeutics Daily - Enter your email address below to receive a concise daily summary of the latest news and analysts' ratings for Iovance Biotherapeutics and related companies with MarketBeat.com's FREE daily email newsletter.

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.

CONTACTS 

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

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

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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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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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.