Six melanoma specialists told CNBC that Phase 3 results for Moderna and Merck's personalized cancer vaccine, intismeran autogene, given with Keytruda represent a clinically meaningful advance. The combination reduced the risk of melanoma recurrence or death by 42% and the risk of distant spread or death by 38% compared with Keytruda alone, in a trial of roughly 1,100 patients whose tumors were surgically removed. Doctors said it could eventually become a standard of care for patients who have surgery first and have not received immunotherapy beforehand, though questions remain about survival benefit and which patients benefit most. Moderna shares fell as much as 25% on Thursday after partial data leaked on social media, even though the stock is up nearly 600% this year on optimism about the cancer shot. Moderna is finishing a regulatory filing and aims to get the drug fully approved next year.
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- Moderna shares plunge after leak of partial cancer vaccine data despite positive results
Moderna shares fell as much as 25% on Thursday after partial data from its cancer vaccine developed with Merck leaked ahead of the full results, which were released later that day. The full data appeared positive relative to Wall Street expectations: the personalized vaccine intismeran autogene, combined with Keytruda, reduced the risk of recurrence or death in certain melanoma patients by 42% versus Keytruda alone, and cut the risk of distant spread or death by 38%. Detailed phase 3 results will be presented at the European Society for Medical Oncology conference this weekend. Investors view the vaccine as a possible breakthrough that could extend to other cancers, and the stock has spiked more than 530% this year on high expectations.
- Moderna's Stock Just Stumbled. Is It a Buy on the Dip?
Moderna shares fell 17% in one session after leaked data from a phase 3 trial of intismeran autogene combined with Merck's Keytruda, though the leaked results showed the drug combo cut the risk of recurrence or death by 42% in certain melanoma patients versus Keytruda alone, and by 58% after six months. The stock has still climbed more than 500% this year, trading near $200 versus an average Wall Street 12-month price estimate of $135. The author sees the dip as possibly a buying opportunity for long-term investors who want to open or add to a position, while cautioning that the stock remains sensitive to trial data and may see further pullbacks. Moderna currently has four commercialized products in the U.S., all respiratory vaccines.
- Moderna Sinks 4% After 18% Plunge as Melanoma Vaccine Selloff Extends; Merck and Pfizer Slip
Moderna shares fell 4% to $193.62 in morning trading, extending an 18% plunge from the prior session, even though full late-stage data for its personalized melanoma vaccine, given with Merck's Keytruda, came back positive. Compared with Keytruda alone, the combination cut the risk of melanoma recurrence or death, a result near analyst expectations but short of the highest hopes built during a rally that began in August. The vaccine carries far more weight for Moderna, whose approved products are all respiratory vaccines, while for Merck it is an add-on to Keytruda; Merck fell 0.8% to $146 and Pfizer 0.7% to $30.22. The iShares Biotechnology ETF was unchanged at $209.54, suggesting the slide is company-specific. The full data will be presented at a medical conference this weekend.
- Stocktwits Pharma Pulse: Moderna-Merck Cancer Vaccine Grabs Spotlight As Kidney-Cancer And MS Data Pour In
Biotech news this week focuses on kidney cancer, multiple sclerosis, Huntington's disease and personalized cancer treatment, as Arcus Biosciences (RCUS), Alnylam (ALNY), Moderna (MRNA) and Merck (MRK) release clinical updates alongside earnings and conferences. Last week, the health care ETF XLV gained 3%, outperforming SPY (down 2%) and QQQ (down 6%), while the biotech ETF XBI fell 6%. Arcus will present kidney-cancer data from its ARC-20 study of Casdatifan, Achieve Life Sciences will report year-long Cytisinicline findings for smoking cessation after a June FDA rejection it says concerned manufacturing and labeling, and Alnylam will share initial Phase 1 ALN-HTT02 results for Huntington's disease. Moderna and Merck will present Phase 3 INTerpath-001 melanoma data on Saturday, comparing individualized treatment intismeran autogene plus Keytruda with Keytruda alone after surgery, while a number of other companies will present multiple sclerosis updates through the week.
- Merck CEO tells CNBC he expects breakthrough cancer vaccine will become faster to make
Merck CEO Rob Davis told CNBC that the personalized cancer vaccine developed with Moderna currently takes about six weeks from tumor sequencing to hospital delivery, and he expects that timeline to shorten over time, though supply and market readiness come first. The vaccine targets each patient's unique tumor mutations and is paired with Keytruda; in August, the companies released positive early data from a late-stage melanoma trial. Merck also opened a 120,000-square-foot R&D facility in West Point, Pennsylvania, as Keytruda nears loss of exclusivity, with its core U.S. compound patent expiring in December 2028. The company plans $65 billion in external acquisitions and licensing deals over five years to bolster its pipeline. A Dutch court has blocked Merck from selling subcutaneous Keytruda in eight European countries, and Merck says it will appeal.
- Merck (MRK) Reports a Negative Operating Margin and Pays Out 266% of Earnings. What Explains Both?
Merck (NYSE:MRK) closed at $145.45 on October 12. In the first quarter it booked an acquired research charge of roughly $9.00 billion tied to the Cidara acquisition, and a further charge for Terns in the second quarter. These went through R&D expense with no tax benefit, which pushes the operating margin below zero. The article argues they are one-time purchase-price write-offs rather than recurring cash costs, since free cash flow came in at several times net income, so the 266.67% payout ratio is distorted; revenue still grew 5.10% in the latest quarter. The bigger question is whether the well over ten billion dollars spent on pipeline assets that have yet to produce revenue can replace sales from its largest product once it loses exclusivity later this decade, with debt at $53.91 billion. The 15.62 forward multiple assumes that bet pays off.
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