Latest news with #Amtagvi
Business Insider
18 hours 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
30-07-2025
- Business
- Yahoo
Is Iovance Biotherapeutics Stock Due for a Big Rally?
Key Points Iovance's stock has been surging, and trading volumes have been up recently, despite no significant news. The company's approved cellular therapy, Amtagvi, has the potential to become a blockbuster in the future. Currently, however, the company is experiencing significant cash burn, and its losses remain high. 10 stocks we like better than Iovance Biotherapeutics › Shares of Iovance Biotherapeutics (NASDAQ: IOVA) have been in a free fall this past year, but in recent weeks, they have experienced a bit of a surge in value. The volatile biotech stock has been picking up steam, and the share price is up roughly 67% in just the past month. For a stock that's been struggling to gain much traction and which is still down roughly 70% over the past year, could this be the start of a much bigger rally, one that may potentially be overdue? Trading volumes and a price spike on no significant news Although Iovance's stock has been rising sharply of late, there hasn't been an obvious catalyst behind the sudden movement. On July 23, trading volumes were above 110 million, which is far higher than normal (daily trading volumes are usually below 20 million for the stock). Iovance didn't publish any meaningful news around the time of the spike that would have explained such a sudden surge. And its latest earnings report isn't due to come out until next week. Such movements suggest that there is a lot of speculation around the healthcare stock, which can make it a volatile holding to put in your portfolio. Iovance has promise, but it also faces considerable risk Unlike other biotech stocks, Iovance already has an approved treatment in its portfolio, making it a bit less risky than most. Last year, it obtained approval for Amtagvi, a cellular therapy for unresectable metastatic melanoma. Analysts are projecting that the treatment will bring in approximately $846 million annually by 2029, and it does have the potential to be a blockbuster product, with its sales expected to reach $1 billion by the end of the decade. The challenge, however, is that in rolling out the therapy to patients, the company will continue to incur hefty costs and burn through cash. In the trailing 12 months, Iovance has used up more than $334 million just from its day-to-day operating activities. And its net loss over that time has totaled $375 million. There's no shortage of people betting against the stock, with short interest rising significantly this year. Should you buy Iovance stock right now? Iovance is a stock that shows promise. It has an approved therapy that is starting to generate sales for the business, which should make it a safer buy than many other options in biotech. And the company is also studying it for other possible indications. At a market cap of right around $1 billion, the company's valuation doesn't appear too high, and it could make for an attractive acquisition target for a larger pharma company. While I don't think Iovance is due for a big rally, simply because there is no catalyst to explain the recent surge -- much less justify a more significant one in the weeks ahead -- it could still make for an intriguing option in the long run, given that it's in the early stages of its growth. There is risk here, but there could also be some considerable upside. Investing in Iovance may not be suitable for most, but if you have a high risk tolerance, Iovance may be worth buying today. Should you buy stock in Iovance Biotherapeutics right now? 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 $633,452!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you'd have $1,083,392!* Now, it's worth noting Stock Advisor's total average return is 1,046% — a market-crushing outperformance compared to 183% for the S&P 500. 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 July 29, 2025 David Jagielski 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 Iovance Biotherapeutics Stock Due for a Big Rally? 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
30-07-2025
- Business
- Yahoo
This Beaten-Down Healthcare Stock Could Jump 720%, According to a Wall Street Analyst. Is It Time to Buy?
Key Points Iovance launched its first product, called Amtagvi, last year. Initial sales aren't bad, but they haven't been as high as previously hoped. Amtagvi is an autologous cellular therapy, which are generally difficult to sell. 10 stocks we like better than Iovance Biotherapeutics › Shares of Iovance Biotherapeutics (NASDAQ: IOVA) are down about 75% from a high-water mark they set last December. Up and down Wall Street, investment bank analysts tasked with following the commercial-stage cancer drug developer are arguing about whether it's fallen too far or not far enough. Over at Chardan Capital, Geulah Livshits reiterated a buy rating and a $25 price target on July 23. From the stock's price of $3.05 on the morning of July 28, Livshits' estimate implies a gain of about 720% in about a year. Not every investment bank is as enthusiastic about Iovance as Chardan Capital, but expectations are still extremely high. When the market opened on July 28, the consensus price target on the stock was $10 per share. The average price target for Iovance Biotherapeutics implies a 228% gain, but those gains are a long way from guaranteed. Let's weigh this company's strengths against some challenges it's facing to see if it's a good stock to buy now. Why some on Wall Street are bullish for Iovance Biotherapeutics stock In February 2024, the Food and Drug Administration approved Amtagvi, Iovance's first product. It's a cell-based treatment for folks with advanced melanoma. Following a tumor biopsy, immune cells called tumor-infiltrating lymphocytes are separated out and expanded. Once reinfused, they go to work attacking tumors. Standard care for melanoma involves PD-1 blocking antibodies such as Merck's Keytruda and other targeted treatments. When standard care fails, though, there is a dearth of options. In the trial leading to its approval, treatment with Amtagvi shrank tumors for 31.5% of patients, all of whom had progressed after receiving a PD-1 blocking therapy. Since its approval, Iovance has been able to evaluate 41 patients who received the therapy, and 20 of them have smaller tumors or no tumors at all. The response rate improved to 60.9% among patients who had received just one or two previous lines of treatment. Why Iovance has attracted downgrades On July 15, analysts at Goldman Sachs downgraded the stock to sell and reduced the bank's price target to $1 per share. In a nutshell, the bank is concerned about a slower-than-expected Amtagvi launch. Amtagvi's commercial launch has three challenges to overcome. Perhaps least significant is the fact that the FDA approved it based on tumor shrinkage, not an overall survival benefit that would take much longer to evaluate. The Amtagvi launch is also hindered by Iovance's relatively small sales team. The company finished 2024 with just 838 employees, 670 of whom are in research, development, and manufacturing. The biggest headwind for Amtagvi is its complicated administration. This isn't a bottle of pills a pharmacist refills every month. It's a bag of live immune cells to be infused once. To give the new cells a chance to find a home in the patient's bone marrow, treatment centers must first deplete their immune system with a week-long chemotherapy regimen. Add these three headwinds up, and what you get is a lack of sales. In the first quarter of 2025, Amtagvi sales reached $43.6 million. That's not terrible, but it doesn't look like this is going to become a huge blockbuster with several billion dollars in annual sales as previously expected. A buy on the dip? Iovance's stock price is off its 52-week lows, and at recent prices it sports a $1.05 billion market cap. That's a relatively low valuation for an independent drugmaker with a new product performing as well as Amtagvi. Management expects to report between $250 million and $300 million in sales this year. Biotech stocks tend to trade at mid-to-high single-digit multiples of trailing 12-month sales. If it turns out Goldman Sachs was wrong, and management maintains its previous revenue estimate, the stock could soar. While Iovance seems underappreciated, it's probably best to wait for second-quarter results, which are expected on Aug. 7. This June, Iovance's chief financial officer announced his resignation. Start-up drugmakers switching CFOs to better support a first product launch isn't unusual, but it usually occurs at the beginning of the launch. A CFO resignation a little over a year into an initial drug launch is the sort of announcement you'd expect from a drugmaker about to issue a disappointing sales guidance revision. While there could be heaps of upside if Amtagvi sales reach Wall Street expectations, it's probably best to play wait-and-see until after the second-quarter report drops. Should you invest $1,000 in Iovance Biotherapeutics right now? 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 $636,628!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you'd have $1,063,471!* Now, it's worth noting Stock Advisor's total average return is 1,041% — a market-crushing outperformance compared to 183% for the S&P 500. 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 July 28, 2025 Cory Renauer 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. This Beaten-Down Healthcare Stock Could Jump 720%, According to a Wall Street Analyst. Is It Time to Buy? 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
Associated Press
14-07-2025
- Business
- Associated Press
DEADLINE ALERT for IOVA, DNUT, and MSTR: The Law Offices of Frank R. Cruz Reminds Investors of Class Actions on Behalf of Shareholders
LOS ANGELES, July 14, 2025 (GLOBE NEWSWIRE) -- The Law Offices of Frank R. Cruz reminds investors that class action lawsuits have been filed on behalf of shareholders of the following publicly-traded companies. Investors have until the deadlines listed below to file a lead plaintiff motion. Investors suffering losses on their investments are encouraged to contact The Law Offices of Frank R. Cruz to discuss their legal rights in these class actions at 310-914-5007 or by email to [email protected]. Iovance Biotherapeutics, Inc. (NASDAQ: IOVA ) Class Period: May 9, 2024 – May 8, 2025 Lead Plaintiff Deadline: July 14, 2025 The complaint filed in this class action alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company's business, operations, and prospects. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (1) new Authorized Treatment Centers were experiencing longer timelines to begin treating patients with Amtagvi; (2) the Company's sales team and new ATCs were ineffective in patient identification and patient selection for Amtagvi, leading to higher patient drop-offs; (3) the foregoing dynamics led to higher costs and lower revenue because ATCs could not keep pace with manufactured product; and (4) that, as a result of the foregoing, Defendants' positive statements about the Company's business, operations, and prospects were materially misleading and/or lacked a reasonable basis. If you are an Iovance shareholder who suffered a loss, click here to participate. Krispy Kreme, Inc. (NASDAQ: DNUT ) Class Period: February 25, 2025 – May 7, 2025 Lead Plaintiff Deadline: May 13, 2025 The complaint filed in this class action alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company's business, operations, and prospects. Specifically, Defendants failed to disclose to investors: (1) that demand for Krispy Kreme products declined materially at McDonald's locations after the initial marketing launch; (2) that demand at McDonald's locations was a driver of declining average sales per door per week; (3) that the partnership with McDonald's was not profitable; (4) that the foregoing posed a substantial risk to maintaining the partnership with McDonald's; (5) that, as a result, the Company would pause expansion into new McDonald's locations; and (6) that, as a result of the foregoing, Defendants' positive statements about the Company's business, operations, and prospects were materially misleading and/or lacked a reasonable basis. If you are a Krispy Kreme shareholder who suffered a loss, click here to participate. MicroStrategy Incorporated d/b/a Strategy (NASDAQ: MSTR ) Class Period: April 30, 2024 – April 4, 2025 Lead Plaintiff Deadline: July 15, 2025 The complaint filed in this class action alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company's business, operations, and prospects. Specifically, Defendants failed to disclose to investors that: (1) the anticipated profitability of the Company's bitcoin-focused investment strategy and treasury operations was overstated; (2) the various risks associated with bitcoin's volatility and the magnitude of losses Strategy could recognize on the value of its digital assets following its adoption of ASU 2023-08 were understated; and (3) as a result, Defendants' positive statements about the Company's business, operations, and prospects were materially misleading and/or lacked a reasonable basis at all relevant times. If you are a MicroStrategy shareholder who suffered a loss, click here to participate. Follow us for updates on Twitter: To be a member of these class actions, you need not take any action at this time; you may retain counsel of your choice or take no action and remain an absent member of the class action. If you wish to learn more about these class actions, or if you have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Frank R. Cruz, of The Law Offices of Frank R. Cruz, 1999 Avenue of the Stars, Suite 1100, Los Angeles, California 90067 at 310-914-5007, by email to [email protected], or visit our website at If you inquire by email please include your mailing address, telephone number, and number of shares purchased. This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules. Contacts The Law Offices of Frank R. Cruz, Los Angeles Frank R. Cruz, 310-914-5007 [email protected]
Malaysian Reserve
13-07-2025
- Business
- Malaysian Reserve
IOVA Deadline: IOVA Investors with Losses in Excess of $100K Have Opportunity to Lead Iovance Biotherapeutics, Inc. Securities Fraud Lawsuit
NEW YORK, July 13, 2025 /PRNewswire/ — Rosen Law Firm, a global investor rights law firm, reminds purchasers of Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) securities between May 9, 2024 and May 8, 2025, both dates inclusive (the 'Class Period'), of the important July 14, 2025 lead plaintiff deadline. So What: If you purchased Iovance securities during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrangement. What to do next: To join the Iovance class action, go to call Phillip Kim, Esq. at 866-767-3653 or email case@ for more information. A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than July 14, 2025. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation. Details of the case: According to the lawsuit, throughout the Class Period, defendants made false and misleading statements and/or failed to disclose that: (1) new Authorized Treatment Centers ('ATCs') were experiencing longer timelines to begin treating patients with Amtagvi; (2) Iovance's sales team and new ATCs were ineffective in patient identification and patient selection for Amtagvi, leading to higher patient drop-offs; (3) the foregoing dynamics led to higher costs and lower revenue because ATCs could not keep pace with manufactured product; and (4) as a result of the foregoing, Defendants' positive statements about Iovance's business, operations, and prospects were materially misleading and/or lacked a reasonable basis. When the true details entered the market, the lawsuit claims that investors suffered damages. Why Rosen Law: We encourage investors to select qualified counsel with a track record of success in leadership roles. Often, firms issuing notices do not have comparable experience, resources, or any meaningful peer recognition. Many of these firms do not actually litigate securities class actions, but are merely middlemen that refer clients or partner with law firms that actually litigate the cases. Be wise in selecting counsel. The Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation. Rosen Law Firm achieved the largest ever securities class action settlement against a Chinese Company at the time. Rosen Law Firm was Ranked No. 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017. The firm has been ranked in the top 4 each year since 2013 and has recovered hundreds of millions of dollars for investors. In 2019 alone the firm secured over $438 million for investors. In 2020, founding partner Laurence Rosen was named by law360 as a Titan of Plaintiffs' Bar. Many of the firm's attorneys have been recognized by Lawdragon and Super Lawyers. To join the Iovance class action, go to or call Phillip Kim, Esq. at 866-767-3653 or email case@ for more information. No Class Has Been Certified. Until a class is certified, you are not represented by counsel unless you retain one. You may select counsel of your choice. You may also remain an absent class member and do nothing at this point. An investor's ability to share in any potential future recovery is not dependent upon serving as lead plaintiff. Follow us for updates on LinkedIn: on Twitter: or on Facebook: Attorney Advertising. Prior results do not guarantee a similar outcome. Contact Information: Laurence Rosen, Kim, Rosen Law Firm, P.A.275 Madison Avenue, 40th FloorNew York, NY 10016Tel: (212) 686-1060Toll Free: (866) 767-3653Fax: (212) 202-3827case@
