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Yahoo
4 days ago
- Business
- Yahoo
New Summit data could slow US approval plans for PD-1/VEGF drug
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. A dual-acting drug developed by Summit Therapeutics and Akeso delayed tumor progression in a Phase 3 lung cancer trial but didn't extend survival, complicating its potential path to approval in the U.S. When administered alongside chemotherapy, the drug, known as ivonescimab, reduced the risk of death or disease progression by 48% compared to chemotherapy alone in patients whose non-small cell lung cancer has a mutation in a gene called EGFR. However, a 21% reduction in death risk, specifically, didn't meet the threshold for statistical significance, Summit said in a statement Friday. Summit intends to seek Food and Drug Administration approval based on the study results. Yet in its statement, the company indicated the timing of a filing is uncertain given the agency has made clear that a survival benefit is 'necessary' to support a submission. Summit shares fell by nearly 20% early Friday. Ivonescimab is the frontrunner among more than a dozen medicines that simultaneously block the proteins PD-1 and VEGF and are seen as a way to build upon widely used cancer immunotherapies like Keytruda. Its success or failure has broad implications for cancer research, making each study readout a closely scrutinized event among scientists and investors. So far, the results Summit and its China-based partner Akeso have accrued are painting a mixed and incomplete picture. A Phase 3 trial in China in non-small cell lung cancer found the drug cut the risk of disease progression or death in half compared to Keytruda, a striking, first-of-its-kind result that sparked interest and investment in PD-1/VEGF drugs. But ivonescimab hasn't yet clearly extended survival in that same study. Summit's drug also hasn't yet proven superior to the Keytruda-chemotherapy regimen that's standard therapy in many lung cancers. The results accrued so far were from trials in China, too, not the kind of multi-country test the FDA prefers. The data revealed Friday were meant to address one of those issues, proving that the benefits Summit and Akeso have observed in China would be replicated in a broader study population. Summit, for its part, said invonescimab's effects on tumor progression were 'clinically meaningful' in 'both Asia and ex-Asia sub-populations,' and demonstrated the 'consistency' of the drug's benefit in each group. The outcome also closely resembled what Akeso reported in a similar study of EGFR-mutated lung cancer in China. No new safety issues were observed either. The data 'demonstrates the potential benefit ivonescimab has to bring to patients around the world, including the United States,' said Summit chairman and co-CEO Robert Duggan, in a statement. Still, the lack of a clear impact on survival in the trial, at least so far, could slow ivonescimab's path to approval in the U.S. Summit implied its results could improve, as the follow-up time for 'western' patients in its trial was less than the median overall survival figure when data were analyzed. It also noted how no FDA-approved regimens in the setting in which ivonescimab was tested have demonstrated a statistically significant effect on survival. The FDA's insistence on such data, though, 'will weigh into Summit's considerations' as to when it might make a submission, the company said. The agency's 'high bar for demonstrated overall survival benefit make approval less likely,' wrote Leerink Partners analyst Daina Graybosch, in a Friday note to investors. Just this week, Merck and Daiichi Sankyo withdrew an approval application in EGFR lung cancer after a drug they've been developing failed to improve survival in a clinical trial. Summit will disclose specific findings at a future medical meeting. A study evaluating ivonescimab and chemotherapy against Keytruda and chemotherapy in non-small cell lung cancer is ongoing. A readout is expected in 2027, according to a federal database. Recommended Reading New Akeso, Summit data stir debate on PD-1/VEGF drugs
Yahoo
24-04-2025
- Business
- Yahoo
This Company's Co-CEOs Just Bought More Shares. Should You?
Nobody has more information about a company than its insiders, especially its executive management team. That's why when one of them buys more shares, it sometimes gives individual investors insights into the company's prospects. If those with the most knowledge think it's worth loading up on the stock, maybe other investors do the same -- or so the argument goes. That brings us to Summit Therapeutics (NASDAQ: SMMT), a clinical-stage biotech whose co-chief executive officers recently bought more shares of the company they lead. Should other investors follow suit? Let's find out. Where to invest $1,000 right now? Our analyst team just revealed what they believe are the 10 best stocks to buy right now. Continue » On April 8, Summit Therapeutics' co-CEOs, Robert Duggan and Maky Zanganeh, each exercised warrants, financial instruments that grant their holders the right (but not the obligation) to acquire a company's shares at a predetermined price before a particular date. Duggan and Zanganeh's warrants wouldn't have expired until December 2029, but they both chose to go ahead and buy almost 4 million shares (each) of the company they lead for $1.58 per share. Many investors and some analysts welcomed the move, seeing it as a sign that Summit's co-CEOs expect the company's shares to rise. But before deciding to jump on the bandwagon, it's essential to look at things other than the CEOs' moves. Do Summit Therapeutics' prospects -- beyond this recent development -- justify investing in the stock today? On the one hand, Summit Therapeutics is a clinical-stage biotech company with a market cap of $20 billion -- which is exceedingly rare for a drugmaker without a single product on the market. Plenty of biotechs with several approved candidates don't have market caps that high. However, Summit's leading candidate, ivonescimab, looks incredibly promising. Last year, it bested Merck's Keytruda -- the world's best-selling medicine -- in a phase 3 clinical trial in one of its most lucrative markets: non-small cell lung cancer (NSCLC), specifically in patients with a PD-L1 protein overexpression. This might have been in a study conducted in China, but it speaks volumes about ivonescimab, which is already approved in that country. Summit is running several late-stage studies for the drug in the U.S., including in NSCLC. It earned the fast-track designation from the U.S. Food and Drug Administration (FDA) for a specific indication in NSCLC. This designation helps speed up the approval process for medicines that target large unmet needs, and for which there are promising signs of efficacy. Summit won't stop at NSCLC. Based on the number of clinical trials ivonescimab is undergoing in China, the investigational therapy could target many indications across several forms of cancer. It has the makings of a pipeline in a single drug, just like Keytruda. The therapy's potential explains why Summit's market cap is so high, despite the company not generating a single dollar in revenue. In my view, it's worth it. True, Summit Therapeutics didn't create ivonescimab itself. It was licensed from its original creator, China-based biopharma Akeso. Summit Therapeutics now holds the rights to market ivonescimab in most regions outside of China, including the most lucrative pharmaceutical areas: the U.S. and Europe. But the fact that Summit isn't ivonescimab's original creator takes nothing away from the biotech: Larger drugmakers often resort to licensing agreements to beef up their pipelines, since early-stage research costs and risks are so high. Summit stumbled upon a drug that could far exceed blockbuster status through a strategy that better-established companies opt for regularly. Some might say it was just a fluke, but in my view, it says much more about the biotech's leadership than the recent exercise of warrants does. Between ivonescimab's potential and the company's leaders, the stock looks attractive for ordinary investors. Before you buy stock in Summit Therapeutics, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the for investors to buy now… and Summit Therapeutics 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 $532,771!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you'd have $593,970!* Now, it's worth noting Stock Advisor's total average return is 781% — a market-crushing outperformance compared to 149% 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 April 21, 2025 Prosper Junior Bakiny has no position in any of the stocks mentioned. The Motley Fool has positions in and recommends Summit Therapeutics. The Motley Fool has a disclosure policy. This Company's Co-CEOs Just Bought More Shares. Should You? was originally published by The Motley Fool Sign in to access your portfolio
Yahoo
23-04-2025
- Business
- Yahoo
This Company's Co-CEOs Just Bought More Shares. Should You?
Nobody has more information about a company than its insiders, especially its executive management team. That's why when one of them buys more shares, it sometimes gives individual investors insights into the company's prospects. If those with the most knowledge think it's worth loading up on the stock, maybe other investors do the same -- or so the argument goes. That brings us to Summit Therapeutics (NASDAQ: SMMT), a clinical-stage biotech whose co-chief executive officers recently bought more shares of the company they lead. Should other investors follow suit? Let's find out. Where to invest $1,000 right now? Our analyst team just revealed what they believe are the 10 best stocks to buy right now. Continue » On April 8, Summit Therapeutics' co-CEOs, Robert Duggan and Maky Zanganeh, each exercised warrants, financial instruments that grant their holders the right (but not the obligation) to acquire a company's shares at a predetermined price before a particular date. Duggan and Zanganeh's warrants wouldn't have expired until December 2029, but they both chose to go ahead and buy almost 4 million shares (each) of the company they lead for $1.58 per share. Many investors and some analysts welcomed the move, seeing it as a sign that Summit's co-CEOs expect the company's shares to rise. But before deciding to jump on the bandwagon, it's essential to look at things other than the CEOs' moves. Do Summit Therapeutics' prospects -- beyond this recent development -- justify investing in the stock today? On the one hand, Summit Therapeutics is a clinical-stage biotech company with a market cap of $20 billion -- which is exceedingly rare for a drugmaker without a single product on the market. Plenty of biotechs with several approved candidates don't have market caps that high. However, Summit's leading candidate, ivonescimab, looks incredibly promising. Last year, it bested Merck's Keytruda -- the world's best-selling medicine -- in a phase 3 clinical trial in one of its most lucrative markets: non-small cell lung cancer (NSCLC), specifically in patients with a PD-L1 protein overexpression. This might have been in a study conducted in China, but it speaks volumes about ivonescimab, which is already approved in that country. Summit is running several late-stage studies for the drug in the U.S., including in NSCLC. It earned the fast-track designation from the U.S. Food and Drug Administration (FDA) for a specific indication in NSCLC. This designation helps speed up the approval process for medicines that target large unmet needs, and for which there are promising signs of efficacy. Summit won't stop at NSCLC. Based on the number of clinical trials ivonescimab is undergoing in China, the investigational therapy could target many indications across several forms of cancer. It has the makings of a pipeline in a single drug, just like Keytruda. The therapy's potential explains why Summit's market cap is so high, despite the company not generating a single dollar in revenue. In my view, it's worth it. True, Summit Therapeutics didn't create ivonescimab itself. It was licensed from its original creator, China-based biopharma Akeso. Summit Therapeutics now holds the rights to market ivonescimab in most regions outside of China, including the most lucrative pharmaceutical areas: the U.S. and Europe. But the fact that Summit isn't ivonescimab's original creator takes nothing away from the biotech: Larger drugmakers often resort to licensing agreements to beef up their pipelines, since early-stage research costs and risks are so high. Summit stumbled upon a drug that could far exceed blockbuster status through a strategy that better-established companies opt for regularly. Some might say it was just a fluke, but in my view, it says much more about the biotech's leadership than the recent exercise of warrants does. Between ivonescimab's potential and the company's leaders, the stock looks attractive for ordinary investors. Before you buy stock in Summit Therapeutics, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the for investors to buy now… and Summit Therapeutics 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 $532,771!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you'd have $593,970!* Now, it's worth noting Stock Advisor's total average return is 781% — a market-crushing outperformance compared to 149% 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 April 21, 2025 Prosper Junior Bakiny has no position in any of the stocks mentioned. The Motley Fool has positions in and recommends Summit Therapeutics. The Motley Fool has a disclosure policy. This Company's Co-CEOs Just Bought More Shares. Should You? was originally published by The Motley Fool
Yahoo
23-02-2025
- Business
- Yahoo
Insider Stock Buying Reaches US$78.8m On Summit Therapeutics
Over the last year, a good number of insiders have significantly increased their holdings in Summit Therapeutics Inc. (NASDAQ:SMMT). This is encouraging because it indicates that insiders are more optimistic about the company's prospects. While insider transactions are not the most important thing when it comes to long-term investing, logic dictates you should pay some attention to whether insiders are buying or selling shares. Check out our latest analysis for Summit Therapeutics The Co-CEO & Executive Chairman Robert Duggan made the biggest insider purchase in the last 12 months. That single transaction was for US$75m worth of shares at a price of US$22.70 each. So it's clear an insider wanted to buy, even at a higher price than the current share price (being US$22.12). While their view may have changed since the purchase was made, this does at least suggest they have had confidence in the company's future. To us, it's very important to consider the price insiders pay for shares. As a general rule, we feel more positive about a stock if insiders have bought shares at above current prices, because that suggests they viewed the stock as good value, even at a higher price. While Summit Therapeutics insiders bought shares during the last year, they didn't sell. The chart below shows insider transactions (by companies and individuals) over the last year. By clicking on the graph below, you can see the precise details of each insider transaction! There are plenty of other companies that have insiders buying up shares. You probably do not want to miss this free list of undervalued small cap companies that insiders are buying. For a common shareholder, it is worth checking how many shares are held by company insiders. Usually, the higher the insider ownership, the more likely it is that insiders will be incentivised to build the company for the long term. It's great to see that Summit Therapeutics insiders own 80% of the company, worth about US$13b. This kind of significant ownership by insiders does generally increase the chance that the company is run in the interest of all shareholders. The fact that there have been no Summit Therapeutics insider transactions recently certainly doesn't bother us. But insiders have shown more of an appetite for the stock, over the last year. It would be great to see more insider buying, but overall it seems like Summit Therapeutics insiders are reasonably well aligned (owning significant chunk of the company's shares) and optimistic for the future. So while it's helpful to know what insiders are doing in terms of buying or selling, it's also helpful to know the risks that a particular company is facing. At Simply Wall St, we've found that Summit Therapeutics has 3 warning signs (1 makes us a bit uncomfortable!) that deserve your attention before going any further with your analysis. But note: Summit Therapeutics may not be the best stock to buy. So take a peek at this free list of interesting companies with high ROE and low debt. For the purposes of this article, insiders are those individuals who report their transactions to the relevant regulatory body. We currently account for open market transactions and private dispositions of direct interests only, but not derivative transactions or indirect interests. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Sign in to access your portfolio
