Latest news with #IovanceBiotherapeutics
Yahoo
20 hours ago
- Business
- Yahoo
Why Iovance Biotherapeutics Stock Was Climbing Today
Key Points Iovance secured conditional approval for its cancer drug in Canada. This is pending the outcome of late-stage clinical trials. 10 stocks we like better than Iovance Biotherapeutics › A piece of good news on the regulatory front and a subsequent bullish analyst update were the factors driving Iovance Biotherapeutics (NASDAQ: IOVA) stock higher on Tuesday. The shares were almost 6% in positive territory in the middle of today's trading session, contrasting very well with the 0.5% slide of the S&P 500 index. Canada's thumbs-up for Amtagvi Just after market close Monday, Iovance announced that its cancer drug Amtagvi had been conditionally approved in Canada for treatment of certain forms of unresectable or metastatic melanoma. This green light from Health Canada, the country's medical regulator, is the biotech's first approval outside its native U.S. Final approval is conditional upon the results of late-stage clinical trials being conducted by the company. It added that it expects to authorize its first specialized treatment center in Canada in order to administer the medicine. It intends to do this at some point in the coming months. Iovance hopes to win approvals for Amtagvi in other jurisdictions with high instances of advanced melanoma specifically, and solid-tumor cancers generally. The drug earned approval from the U.S. Food and Drug Administration (FDA) for a similar indication in February 2024. It was the first cellular therapy to get the FDA's nod. Positive momentum Tuesday morning, H.C. Wainwright analyst Joseph Pantginis reiterated his buy recommendation on Iovance and his $20 per share price target. Not surprisingly, Pantginis' update was focused on the Health Canada move, according to reports. He wrote that it could be something of an inflection point for the healthcare company because Amtagvi will start producing a new revenue stream after final approval and boost the chances of a green light in other jurisdictions. Do the experts think Iovance Biotherapeutics is a buy right now? The Motley Fool's expert analyst team, drawing on years of investing experience and deep analysis of thousands of stocks, leverages our proprietary Moneyball AI investing database to uncover top opportunities. They've just revealed their to buy now — did Iovance Biotherapeutics make the list? When our Stock Advisor analyst team has a stock recommendation, it can pay to listen. After all, Stock Advisor's total average return is up 1,076% vs. just 184% for the S&P — that is beating the market by 892.04%!* Imagine if you were a Stock Advisor member when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you'd have $671,466!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you'd have $1,115,633!* The 10 stocks that made the cut could produce monster returns in the coming years. Don't miss out on the latest top 10 list, available when you join Stock Advisor. See the 10 stocks » *Stock Advisor returns as of August 18, 2025 Eric Volkman 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. Why Iovance Biotherapeutics Stock Was Climbing Today 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


Business Insider
3 days ago
- Business
- Business Insider
Iovance Amtagvi receives Health Canada approval for advanced melanoma
Iovance Biotherapeutics (IOVA) announced Health Canada has issued a notice of compliance with conditions for Amtagvi, a tumor-derived autologous T cell immunotherapy. Amtagvi is indicated for the treatment of adult patients with unresectable or metastatic melanoma that has progressed on or after at least one prior systemic therapy including a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor, and who have no satisfactory alternative treatment options. Elevate Your Investing Strategy: Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence.
Yahoo
10-08-2025
- Business
- Yahoo
Why Iovance Biotherapeutics Stock Plummeted Today
Key Points Investors were hardly pleased by the company's double miss on second-quarter results. At least its revenue guidance was in line with expectations. 10 stocks we like better than Iovance Biotherapeutics › Investors are typically quite harsh on publicly traded companies that don't make their quarterly estimates, a dynamic vividly on display Friday with biotech stock Iovance Biotherapeutics (NASDAQ: IOVA). The company published its second-quarter earnings after market close the previous day, and the market reacted by trading the stock down by more than 20%. Amtagvi leads the way Iovance, a commercial-stage biotech that's focused on cell therapies for cancer treatment, reported slightly under $60 million in revenue for the period, which was nearly double the $31 million it earned in the same quarter of 2024. All of this is derived from sales of two products: Amtagvi and Proleukin. The former was by far the company's star, with over $54 million in sales. The steep increase in sales didn't filter down into a net profit, however. In fact, Iovance's GAAP (generally accepted accounting principles) net loss deepened during the quarter, coming in at almost $112 million ($0.33 per share) from the year-ago deficit of $97 million. Also, analysts were expecting Iovance to boost its top line even more. Their consensus estimate for revenue was a shade over $67 million. As for net loss, they were modeling a deficit of only $0.28 per share. In its earnings release, Iovance nevertheless sounded a bullish note about the future of its two commercialized products. It quoted CEO Frederick Vogt as saying that "Growth for Amtagvi and Proleukin will continue in the second half of 2025 as existing authorized treatment center growth continues and large community practices begin treating patients." No move on revenue guidance Investors might have liked to see that statement bolstered by a guidance raise. However, Iovance stuck to its existing forecast of $250 million to $300 million anchored, of course, by Amtagvi. The company pointed out that this is the first full year of Amtagvi sales, implying the future should be much rosier for the product. Do the experts think Iovance Biotherapeutics is a buy right now? The Motley Fool's expert analyst team, drawing on years of investing experience and deep analysis of thousands of stocks, leverages our proprietary Moneyball AI investing database to uncover top opportunities. They've just revealed their to buy now — did Iovance Biotherapeutics make the list? When our Stock Advisor analyst team has a stock recommendation, it can pay to listen. After all, Stock Advisor's total average return is up 1,047% vs. just 181% for the S&P — that is beating the market by 865.68%!* Imagine if you were a Stock Advisor member when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you'd have $636,563!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you'd have $1,108,033!* The 10 stocks that made the cut could produce monster returns in the coming years. Don't miss out on the latest top 10 list, available when you join Stock Advisor. See the 10 stocks » *Stock Advisor returns as of August 4, 2025 Eric Volkman 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. Why Iovance Biotherapeutics Stock Plummeted Today was originally published by The Motley Fool Sign in to access your portfolio
Yahoo
08-08-2025
- Business
- Yahoo
Iovance cuts staff amid slow sales start for ‘TIL' cell therapy
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. Iovance Biotherapeutics will lay off staff in a restructuring that follows a significant cut to its revenue forecasts earlier this year. A spokesperson on Thursday confirmed Iovance's plans to reduce its workforce by 'less than 20%.' A regulatory filing showed Iovance employed 838 people at the end of last year, though a company presentation last month indicated that number had grown to more than 1,000. Iovance's workforce will still have more than 1,000 people following the job cuts, which will affect full-time employees as well as contractors, according to the spokesperson. 'After careful evaluation of our long-term goals, operational needs, and resources, we have implemented a strategic restructuring that includes a selective reduction in force to support our mission to innovate, develop and deliver TIL cell therapy to patients in need,' the spokesperson wrote in an email, referring to the type of cellular medicine Iovance specializes in. 'This restructuring will extend our cash runway, and we remain on track to deliver on our financial goals.' In a second quarter earnings report Thursday afternoon, the company said that 19% of its workforce would be impacted by the cuts. The restructuring will save Iovance more than $100 million annually and enable it to operate through the fourth quarter of 2026. Iovance will also 'continue to optimize and refine its cost structure' through what it described as 'operational excellence initiatives' over the next few quarters, it said in a statement. Iovance had about $307 million in cash on hand at the end of June. The layoffs come after a slow commercial start for Amtagvi, a cell therapy Iovance developed for an advanced form of skin cancer. Amtagvi is the first marketed cellular medicine made by engineering human cells known as tumor-infiltrating lymphocytes, or 'TILs.' The therapy originated from research at the National Institutes of Health in the 1980s and got to market only after decades of fine-tuning, as well as multiple regulatory delays. Amtagvi was cleared in February 2024 for people whose melanoma progressed after a commonly used immunotherapy or targeted cancer medication. It's derived from a patient's tumor tissue in a complex, weekslong manufacturing process. Upon approval, analysts and investors were skeptical of its sales potential, given questions about demand and the complex logistics involved. At about $515,000, the drug's list price was also at the time the highest of any cell-based medicine for cancer in the U.S. Iovance initially projected product revenue — which includes contributions from a different immunotherapy called Proleukin — would reach $450 million to $475 million this year. But in May, it cut that forecast by 40%, to between $250 million to $300 million, citing 'recent launch dynamics' that had changed its view. In a research note last month, Mizuho Securities analyst Salim Syed noted how prior guidance was modeled on launches from other marketed cancer cell therapies known as CAR-T treatments, whereas the updated projections rely on 'real data' from centers actively administering Amtagvi. Iovance said in its latest earnings report that 102 patients were treated with Amtagvi in the second quarter, equating to about $54 million in sales. Shares fell about 30% as the numbers 'were on the lighter side' of the 100 to 110 patients Iovance had anticipated treating, and total product revenue of $60 million missed consensus estimates, wrote Syed in a note to clients Thursday. Amtagvi could be approved in Europe, the U.K. and Canada this year. It's also in late-stage testing for non-small cell lung cancer. Iovance shares have lost most of their value over the last 12 months. Editor's note: This story has been updated to include details from Iovance's earnings report. Recommended Reading Treeline Bio deepens investor roots with fresh funding for cancer drug research 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
08-08-2025
- Business
- Yahoo
Iovance Biotherapeutics (IOVA) Reports Q2 Loss, Lags Revenue Estimates
Iovance Biotherapeutics (IOVA) came out with a quarterly loss of $0.33 per share versus the Zacks Consensus Estimate of a loss of $0.29. This compares to a loss of $0.34 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of -13.79%. A quarter ago, it was expected that this biotechnology company would post a loss of $0.25 per share when it actually produced a loss of $0.36, delivering a surprise of -44%. Over the last four quarters, the company has surpassed consensus EPS estimates two times. Iovance Biotherapeutics, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $59.95 million for the quarter ended June 2025, missing the Zacks Consensus Estimate by 9.64%. This compares to year-ago revenues of $31.11 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 lost about 65.1% since the beginning of the year versus the S&P 500's gain of 7.9%. What's Next for Iovance Biotherapeutics? While Iovance Biotherapeutics has underperformed 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 unfavorable. 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 #5 (Strong Sell) for the stock. So, the shares are expected to underperform 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 -$0.27 on $80.18 million in revenues for the coming quarter and -$1.15 on $290.49 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 41% 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, Avidity Biosciences, Inc. (RNA), is yet to report results for the quarter ended June 2025. This company is expected to post quarterly loss of $0.93 per share in its upcoming report, which represents a year-over-year change of -43.1%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. Avidity Biosciences, Inc.'s revenues are expected to be $2.1 million, up 2.4% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Iovance Biotherapeutics, Inc. (IOVA) : Free Stock Analysis Report Avidity Biosciences, Inc. (RNA) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research Sign in to access your portfolio