Moderna's norovirus vaccine has hit a roadblock. On July 31, the company said its Phase 3 trial of the mRNA candidate for the gastrointestinal virus did not achieve the early success criteria. Moderna emphasized that the study is continuing. On a conference call, executives said they are adding another group of volunteers to evaluate the seasonal vaccine during the winter.
The norovirus program is part of Moderna's larger strategy to depend less on the Covid shot. Moderna expects the Food and Drug Administration to rule on its mRNA-based flu vaccine by Aug. 5. A green light would open the door for a combined flu-Covid shot to reach the U.S. market.
The company recorded a loss of $1.97 per share for the quarter, narrower than analysts expected. It also stuck with its prior guidance of as much as 10% revenue growth for this year. When New York trading began, the shares moved between positive and negative territory. The stock last traded at $55.72, a 3.81% move, while Merck & Co. stood at $130.76.
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The personalized cancer vaccine being developed with Merck & Co. has produced encouraging data in preventing high-risk melanoma from coming back. It is also being studied for other cancers. Moderna has said late-stage melanoma results may be released this year.
Moderna's flu vaccine has had an unusual path to the FDA. In February, the agency declined to review the company's application, then abruptly changed course. The public disagreement with regulators highlighted how politically charged mRNA technology has become.
In June, FDA advisers voted unanimously in favor of the vaccine. The agency is not required to follow their advice, but it generally does.
Upcoming catalysts for Moderna include a decision on the flu vaccine by Aug. 5, possible late-stage melanoma data this year, and winter testing of its norovirus shot.
Moderna is trying to build a broader franchise beyond Covid, and these events are part of that goal. An approved flu shot would add a second product in the U.S., while a successful norovirus vaccine could also become a seasonal offering. The cancer collaboration with Merck represents a completely different market from infectious disease, which is why investors have watched it closely.
The company's plan depends on these programs advancing. If the norovirus shot succeeds in winter testing, Moderna would have another seasonal product beyond flu and Covid, reducing its reliance on the Covid vaccine. The Merck partnership likewise gives investors a reason to view Moderna as more than a one-vaccine company.
Moderna still has several key events on the horizon for investors. Moderna's shares have already nearly doubled this year, helped by enthusiasm for its cancer vaccine partnership with Merck, but the company still needs to broaden beyond Covid. That gives each pipeline update outsize importance.
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