Latest news with #Proleukin
Malaysian Reserve
27-05-2025
- Business
- Malaysian Reserve
Investors Should Contact Levi & Korsinsky Before July 14, 2025 to Discuss Your Rights
NEW YORK, May 27, 2025 /PRNewswire/ — Levi & Korsinsky, LLP notifies investors in Iovance Biotherapeutics, Inc. ('Iovance' or the 'Company') (NASDAQ: IOVA) of a class action securities lawsuit. CLASS DEFINITION: The lawsuit seeks to recover losses on behalf of Iovance investors who were adversely affected by alleged securities fraud between May 9, 2024 and May 8, 2025. Follow the link below to get more information and be contacted by a member of our team: IOVA investors may also contact Joseph E. Levi, Esq. via email at jlevi@ or by telephone at (212) 363-7500. CASE DETAILS: According to the complaint, throughout the class period, defendants provided overwhelmingly positive statements to investors while, at the same time, disseminating materially false and misleading statements and/or concealing material adverse facts concerning the true state of Iovance's growth potential; notably, that it was not equipped to generate and drive demand or was otherwise ill equipped to capitalize upon the purported existing demand for its treatments through its network of approved treatment centers. On July 25, 2024, Iovance announced its financial results for the second quarter of fiscal 2024 and reduced its revenue guidance for the full fiscal year 2024. The Company attributed its results and lowered guidance on 1) 'the iCTC completed annual scheduled maintenance in December' and 'capacity was reduced by more than half for about 1 month,' 2) '[l]ower Proleukin sales' than the company expected, and 3) 'the variable pace at which ATCs began treatment patients.' Following this news, the price of Iovance's common stock declined dramatically. From a closing market price of $3.17 per share on May 8, 2025, Iovance's stock price fell to $1.75 per share on May 9, 2025, a decline of about 44.795% in the span of just a single day. WHAT'S NEXT? If you suffered a loss in Iovance during the relevant time frame, you have until July 14, 2025 to request that the Court appoint you as lead plaintiff. Your ability to share in any recovery doesn't require that you serve as a lead plaintiff. NO COST TO YOU: If you are a class member, you may be entitled to compensation without payment of any out-of-pocket costs or fees. There is no cost or obligation to participate. WHY LEVI & KORSINSKY: Over the past 20 years, the team at Levi & Korsinsky has secured hundreds of millions of dollars for aggrieved shareholders and built a track record of winning high-stakes cases. Our firm has extensive expertise representing investors in complex securities litigation and a team of over 70 employees to serve our clients. For seven years in a row, Levi & Korsinsky has ranked in ISS Securities Class Action Services' Top 50 Report as one of the top securities litigation firms in the United States. CONTACT:Levi & Korsinsky, LLP Joseph E. Levi, Korsinsky, Esq.33 Whitehall Street, 17th FloorNew York, NY 10004jlevi@ (212) 363-7500Fax: (212)
Yahoo
15-05-2025
- Business
- Yahoo
Is This Beaten-Down Stock a Buy Near Its 52-Week Low?
Iovance Biotherapeutics is generating growing revenue thanks to a newly approved product. The company recently cut its guidance for the rest of 2025. Though there's massive upside potential for the stock, there's also significant risk. 10 stocks we like better than Iovance Biotherapeutics › Penny stocks -- companies with shares trading at around $5 or even less apiece -- usually carry above-average risk. However, there may be hidden gems among them: companies with attractive prospects that continue to be ignored by most investors. Identifying those penny stocks with significant latent upside potential and investing in them before they catch fire can lead to life-changing returns. That brings us to Iovance Biotherapeutics (NASDAQ: IOVA), a small-cap biotech that has significantly lagged the market over the past year. The stock trades below $2 per share, around its 52-week low. But many, including some Wall Street analysts, think it's deeply undervalued. Should investors take a chance on Iovance? One might think things are going well for Iovance Biotherapeutics. Last year, it earned approval for Amtagvi, a medicine for metastatic melanoma (skin cancer). It was a significant regulatory milestone for the company, since it helped demonstrate that Iovance's approach to treating cancer -- one that harnesses the power of patients' own tumor-infiltrating lymphocytes (TILs, white blood cells that can kill cancer cells) -- isn't just a theory. Since Amtagvi's approval, Iovance has also made decent commercial headway. The company reported $49.3 million in revenue in the first quarter, while the amount it had in the year-ago period was not meaningful. This first-quarter top line might not look too impressive, but the recent update was disappointing for a different reason: Iovance cut its revenue guidance for the year to between $250 million and $300 million. It had previously projected it would record between $450 million and $475 million. Why the change? Because of the complexity of manufacturing (the process for Amtagvi takes about 34 days) and administering TIL-based therapies, Iovance needs to have specialized authorized treatment centers (ATCs) in which to tend to patients. The more ATCs in its network, the more people it can treat. Iovance had to revise its guidance because it previously overestimated the growth trajectory of ATC enrollment. Still, the market hates downward guidance revisions, so it's not surprising that the company's shares fell off a cliff following its first-quarter update. Iovance's consensus analyst estimate (according to Yahoo! Finance) is $19.58, which implies a significant upside from its current levels. Bulls could point to several things that could jolt the share price. First, even revenue of $275 million (the midpoint of Iovance's guidance for the year) would be impressive for a company that earned approval for its first product last year. (It does market another cancer medicine called Proleukin, which it got through an acquisition, but that only racked up $5.7 million in sales in the first quarter.) Revenue above $200 million for a first full year on the market is competitive for a brand-new medicine. At this rate, Amtagvi could hit blockbuster status within four years as Iovance gets more ATCs activated. Second, the company is seeking approval for Amtagvi in many other countries and regions, including Canada, Europe, and Australia. That will significantly expand the medicine's addressable market. Considering its fairly successful launch in the U.S., Amtagvi's prospects worldwide make it likely to exceed $2 billion in annual sales at its peak, and that's in this indication alone in treating melanoma. Third, Iovance will seek label expansions for Amtagvi, so the medicine's potential looks attractive. That said, Iovance Biotherapeutics is a risky stock, and the recent setback highlights one reason. The process to manufacture and administer Amtagvi, which requires specialized ATCs, increases costs compared to the production and administration of a simple oral pill, or even of subcutaneous injections. So, though Iovance can expand beyond the U.S. market and generate higher revenue, the company will have trouble keeping costs down. And although Iovance Biotherapeutics is running plenty of studies to earn new indications, clinical setbacks would sink the share price. Even as it hovers near its 52-week low, the stock looks too risky for investors to jump in. Before you buy stock in Iovance Biotherapeutics, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the for investors to buy now… and Iovance Biotherapeutics wasn't one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you'd have $613,951!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you'd have $796,353!* Now, it's worth noting Stock Advisor's total average return is 948% — a market-crushing outperformance compared to 170% for the S&P 500. Don't miss out on the latest top 10 list, available when you join . See the 10 stocks » *Stock Advisor returns as of May 12, 2025 Prosper Junior Bakiny has no position in any of the stocks mentioned. The Motley Fool has positions in and recommends Iovance Biotherapeutics. The Motley Fool has a disclosure policy. Is This Beaten-Down Stock a Buy Near Its 52-Week Low? was originally published by The Motley Fool Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
02-05-2025
- Business
- Yahoo
Iovance Biotherapeutics to Host First Quarter 2025 Financial Results and Corporate Updates Webcast on Thursday, May 8, 2025
SAN CARLOS, Calif., May 02, 2025 (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 report its first quarter 2025 financial results and corporate updates on Thursday, May 8, 2025. Management will host a conference call and live audio webcast to discuss these results and provide a corporate update on May 8, 2025 at 4:30 p.m. ET. To listen to the live or archived audio webcast, please register at The live and archived webcast can be accessed in the Investors section of the Company's website, The archived webcast will be available for one year. About Iovance Biotherapeutics, Inc. Iovance Biotherapeutics, Inc. aims to be the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) therapies for patients with cancer. We are pioneering a transformational approach to cure cancer by harnessing the human immune system's ability to recognize and destroy diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. Iovance's Amtagvi® is the first FDA-approved T cell therapy for a solid tumor indication. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, that may extend and improve life for patients with cancer. For more information, please visit Amtagvi® and its accompanying design marks, Proleukin®, Iovance®, and IovanceCares™ are trademarks and registered trademarks of Iovance Biotherapeutics, Inc. or its subsidiaries. All other trademarks and registered trademarks are the property of their respective owners. Forward-Looking Statements Certain matters discussed in this press release are 'forward-looking statements' of Iovance Biotherapeutics, Inc. (hereinafter referred to as the 'Company,' 'we,' 'us,' or 'our') within the meaning of the Private Securities Litigation Reform Act of 1995 (the 'PSLRA'). Without limiting the foregoing, we may, in some cases, use terms such as 'predicts,' 'believes,' 'potential,' 'continue,' 'estimates,' 'anticipates,' 'expects,' 'plans,' 'intends,' 'forecast,' 'guidance,' 'outlook,' 'may,' 'can,' 'could,' 'might,' 'will,' 'should,' or other words that convey uncertainty of future events or outcomes and are intended to identify forward-looking statements. Forward-looking statements are based on assumptions and assessments made in light of management's experience and perception of historical trends, current conditions, expected future developments, and other factors believed to be appropriate. Forward-looking statements in this press release are made as of the date of this press release, and we undertake no duty to update or revise any such statements, whether as a result of new information, future events or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties, and other factors, many of which are outside of our control, that may cause actual results, levels of activity, performance, achievements, and developments to be materially different from those expressed in or implied by these forward-looking statements. Important factors that could cause actual results, developments, and business decisions to differ materially from forward-looking statements are described in the sections titled "Risk Factors" in our filings with the U.S. Securities and Exchange Commission, including our most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, and include, but are not limited to, the following substantial known and unknown risks and uncertainties inherent in our business: the risks related to our ability to successfully commercialize our products, including Amtagvi, for which we have obtained U.S. Food and Drug Administration ('FDA') approval, and Proleukin, for which we have obtained FDA and European Medicines Agency ('EMA') approval; the risk that the EMA or other ex-U.S. regulatory authorities may not approve or may delay approval for our marketing authorization application submission for lifileucel in metastatic melanoma; the acceptance by the market of our products, including Amtagvi and Proleukin, and their potential pricing and/or reimbursement by payors, if approved (in the case of our product candidates), in the U.S. and other international markets and whether such acceptance is sufficient to support continued commercialization or development of our products, including Amtagvi and Proleukin, or product candidates, respectively; future competitive or other market factors may adversely affect the commercial potential for Amtagvi or Proleukin; the risk regarding our ability or inability to manufacture our therapies using third party manufacturers or at our own facility, including our ability to increase manufacturing capacity at such third party manufacturers and our own facility, may adversely affect our commercial launch; the results of clinical trials with collaborators using different manufacturing processes may not be reflected in our sponsored trials; the risk regarding the successful integration of the recent Proleukin acquisition; the risk that the successful development or commercialization of our products, including Amtagvi and Proleukin, 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 FDA, EMA, or other regulatory authority approval of, or other action with respect to, our product candidates; whether clinical trial results from our pivotal studies and cohorts, and meetings with the FDA, EMA, or other regulatory authorities may support registrational studies and subsequent approvals by the FDA, EMA, or other regulatory authorities, including the risk that the planned single arm Phase 2 IOV-LUN-202 trial may not support registration; preliminary and interim clinical results, which may include efficacy and safety results, from ongoing clinical trials or cohorts may not be reflected in the final analyses of our ongoing clinical trials or subgroups within these trials or in other prior trials or cohorts; the risk that enrollment may need to be adjusted for our trials and cohorts within those trials based on FDA and other regulatory agency input; the risk that the changing landscape of care for cervical cancer patients may impact our clinical trials in this indication; the risk that we may be required to conduct additional clinical trials or modify ongoing or future clinical trials based on feedback from the FDA, EMA, or other regulatory authorities; the risk that our interpretation of the results of our clinical trials or communications with the FDA, EMA, or other regulatory authorities may differ from the interpretation of such results or communications by such regulatory authorities (including from our prior meetings with the FDA regarding our non-small cell lung cancer clinical trials); 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 may not continue to 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 pandemic; the effects of global and domestic geopolitical factors; and other factors, including general economic conditions and regulatory developments, not within our control. Any financial guidance provided in this press release assumes the following: no material change in our ability to manufacture our products; no material change in payor coverage; no material change in revenue recognition policies; no new business development transactions not completed as of the period covered by this press release; and no material fluctuation in exchange rates. CONTACTS InvestorsIR@ ext. 150 MediaPR@ 650-260-7120 ext. 150Sign in to access your portfolio
Yahoo
10-02-2025
- Business
- Yahoo
Iovance Biotherapeutics Appoints Dan Kirby as Chief Commercial Officer
SAN CARLOS, Calif., Feb. 10, 2025 (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 Dan Kirby will join the Company's executive leadership team in the newly created role of Chief Commercial Officer, effective today. 'I would like to extend a warm welcome to Dan Kirby on behalf of the entire Iovance team,' stated Frederick Vogt, Ph.D., J.D., Interim President, Chief Executive Officer and board member of Iovance. 'Dan has been instrumental in building and leading cell therapy commercial organizations since the earliest developments in the field. He is the perfect fit for Chief Commercial Officer as we grow the U.S. launch of Amtagvi and prepare to enter new markets around the world while also expanding our Proleukin sales.' Prior to joining Iovance, Mr. Kirby led global commercial strategy for an emerging cell therapy platform of products as Chief Commercial Officer of Orca Bio. From 2018 to 2020, he served as Chief Commercial Officer at Omeros Corporation, overseeing U.S. and EU launch readiness for narsoplimab, a lectin pathway inhibitor, for hematopoietic stem cell transplantation-associated thrombotic microangiopathy. Previously, he led market access, reimbursement and marketing efforts for CAR T products as Vice President and Head of US Cell and Gene at Celgene (now Bristol-Myers Squibb). He joined Celgene following the acquisition of Juno Therapeutics, where he was Vice President of Marketing and Market Access. Earlier in his career, Mr. Kirby was Head of Marketing for Medivation (now Pfizer) and held various commercial roles of increasing responsibility during a 14-year tenure at Amgen. His strengths also include market engagement, reimbursement landscape evaluation, value story creation, key opinion leader outreach, communications and advocacy. 'I am pleased to join Iovance at such an exciting time as we catalyze and expand the commercial launch of Amtagvi and growth of Proleukin within the U.S. and beyond,' said Mr. Kirby. 'As the global leader in TIL cell therapy, Iovance is strongly positioned to be the flagship cell therapy company for many thousands of patients with solid tumor cancers for decades to come.' About Iovance Biotherapeutics, Inc. Iovance Biotherapeutics, Inc. aims to be the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) therapies for patients with cancer. We are pioneering a transformational approach to cure cancer by harnessing the human immune system's ability to recognize and destroy diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. Iovance's Amtagvi® is the first FDA-approved T cell therapy for a solid tumor indication. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, that may extend and improve life for patients with cancer. For more information, please visit Amtagvi® and its accompanying design marks, Proleukin®, Iovance®, and IovanceCares™ are trademarks and registered trademarks of Iovance Biotherapeutics, Inc. or its subsidiaries. All other trademarks and registered trademarks are the property of their respective owners. Forward-Looking Statements Certain matters discussed in this press release are 'forward-looking statements' of Iovance Biotherapeutics, Inc. (hereinafter referred to as the 'Company,' 'we,' 'us,' or 'our') within the meaning of the Private Securities Litigation Reform Act of 1995 (the 'PSLRA'). Without limiting the foregoing, we may, in some cases, use terms such as 'predicts,' 'believes,' 'potential,' 'continue,' 'estimates,' 'anticipates,' 'expects,' 'plans,' 'intends,' 'forecast,' 'guidance,' 'outlook,' 'may,' 'can,' 'could,' 'might,' 'will,' 'should,' or other words that convey uncertainty of future events or outcomes and are intended to identify forward-looking statements. Forward-looking statements are based on assumptions and assessments made in light of management's experience and perception of historical trends, current conditions, expected future developments, and other factors believed to be appropriate. Forward-looking statements in this press release are made as of the date of this press release, and we undertake no duty to update or revise any such statements, whether as a result of new information, future events or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties, and other factors, many of which are outside of our control, that may cause actual results, levels of activity, performance, achievements, and developments to be materially different from those expressed in or implied by these forward-looking statements. Important factors that could cause actual results, developments, and business decisions to differ materially from forward-looking statements are described in the sections titled "Risk Factors" in our filings with the U.S. Securities and Exchange Commission, including our most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, and include, but are not limited to, the following substantial known and unknown risks and uncertainties inherent in our business: the risks related to our ability to successfully commercialize our products, including Amtagvi, for which we have obtained U.S. Food and Drug Administration ('FDA') approval, and Proleukin, for which we have obtained FDA and European Medicines Agency ('EMA') approval; the risk that the EMA or other ex-U.S. regulatory authorities may not approve or may delay approval for our marketing authorization application submission for lifileucel in metastatic melanoma; the acceptance by the market of our products, including Amtagvi and Proleukin, and their potential pricing and/or reimbursement by payors, if approved (in the case of our product candidates), in the U.S. and other international markets and whether such acceptance is sufficient to support continued commercialization or development of our products, including Amtagvi and Proleukin, or product candidates, respectively; future competitive or other market factors may adversely affect the commercial potential for Amtagvi or Proleukin; the risk regarding our ability or inability to manufacture our therapies using third party manufacturers or at our own facility, including our ability to increase manufacturing capacity at such third party manufacturers and our own facility, may adversely affect our commercial launch; the results of clinical trials with collaborators using different manufacturing processes may not be reflected in our sponsored trials; the risk regarding the successful integration of the recent Proleukin acquisition; the risk that the successful development or commercialization of our products, including Amtagvi and Proleukin, 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 FDA, EMA, or other regulatory authority approval of, or other action with respect to, our product candidates; whether clinical trial results from our pivotal studies and cohorts, and meetings with the FDA, EMA, or other regulatory authorities may support registrational studies and subsequent approvals by the FDA, EMA, or other regulatory authorities, including the risk that the planned single arm Phase 2 IOV-LUN-202 trial may not support registration; preliminary and interim clinical results, which may include efficacy and safety results, from ongoing clinical trials or cohorts may not be reflected in the final analyses of our ongoing clinical trials or subgroups within these trials or in other prior trials or cohorts; the risk that enrollment may need to be adjusted for our trials and cohorts within those trials based on FDA and other regulatory agency input; the risk that the changing landscape of care for cervical cancer patients may impact our clinical trials in this indication; the risk that we may be required to conduct additional clinical trials or modify ongoing or future clinical trials based on feedback from the FDA, EMA, or other regulatory authorities; the risk that our interpretation of the results of our clinical trials or communications with the FDA, EMA, or other regulatory authorities may differ from the interpretation of such results or communications by such regulatory authorities (including from our prior meetings with the FDA regarding our non-small cell lung cancer clinical trials); 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 may not continue to 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 pandemic; the effects of global and domestic geopolitical factors; and other factors, including general economic conditions and regulatory developments, not within our control. Any financial guidance provided in this press release assumes the following: no material change in our ability to manufacture our products; no material change in payor coverage; no material change in revenue recognition policies; no new business development transactions not completed as of the period covered by this press release; and no material fluctuation in exchange rates. CONTACTS Iovance Biotherapeutics, Inc:Sara Pellegrino, IRCSenior Vice President, Investor Relations & Corporate Communications650-260-7120 ext. Jen SaundersSenior Director, Investor Relations & Corporate Communications
