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Moderna Pops On An FDA Boon For Its Merck-Tied Cancer Vaccine

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Moderna (MRNA) stock jumped late Wednesday after the Food and Drug Administration granted its Merck (MRK)-partnered cancer vaccine a breakthrough designation.




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The companies are testing the personalized cancer vaccine in combination with Merck’s Keytruda in patients with melanoma following surgery.

With the designation, the FDA is acknowledging the regimen could offer a substantial improvement over currently available therapies. The designation also allows the agency to expedite its review process.

In after-hours trading on today’s stock market, Moderna stock rose 2.9% near 162.80. Merck stock gained a fraction, trading near 110.

Moderna Stock: ‘A New Frontier’

The personalized cancer vaccine uses the same messenger RNA platform as Moderna’s blockbuster Covid vaccine.

In this case, it prompts the immune system to create T cells capable of handling a patient’s tumor cells. Patients who received bespoke vaccines on top of Keytruda were 44% less likely to relapse or die than those who received Keytruda alone. Keytruda is the standard of care for these patients.

Moderna stock soared nearly 20% the day it announced those results.

Keytruda works by uncovering tumor cells hiding from the immune system. The cancer vaccine adds another layer — handing the immune system the keys to the tumor’s unique DNA signature. So, if the cancer returns, the T cells are ready to go.

Moderna President Stephen Hoge said in a written statement that the cancer vaccine “represents a new frontier in treating melanoma and other cancers.” But Moderna stock has fallen off since mid-January.

Cancer Vaccine Key To Growth?

Moderna stock is sitting on a floor at its 200-day moving average, MarketSmith.com shows.

The company is due to report its fourth-quarter earnings before the opening bell Thursday. Wall Street expects steep declines in sales and adjusted earnings. That trend is expected to continue for the following two quarters. Analysts expect a return to growth in the third quarter.

But long-term growth will depend on newer products like the cancer vaccine and a potential shot targeting respiratory syncytial virus in older adults. Moderna stock investors are watching the next steps for the RSV vaccine, which also has a breakthrough designation.

Follow Allison Gatlin on Twitter at @IBD_AGatlin.

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