Moderna has faced good and bad times in recent years.
Most recently, the FDA refused to review Moderna’s flu candidate -- then reversed course.
Moderna (NASDAQ: MRNA) soared into the spotlight during the pandemic thanks to its mRNA technology and its rapid development of a coronavirus vaccine. But it's those two elements that have weighed on the stock in more recent times: The U.S. last year ended about $500 million in funding for mRNA vaccine development. And the coronavirus vaccine, facing lower demand, is no longer delivering the same levels of revenue that it did at its peak.
The company has had its ups -- the approval of its respiratory syncytial virus (RSV) vaccine back in 2024 -- and its downs -- the failure of its cytomegalovirus (CMV) vaccine candidate in a phase 3 trial a few months ago.
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If you're thinking about buying Moderna stock, here's what you need to know first.
Image source: Getty Images.
First, it's important to note that the ups and downs have sent investors on a roller coaster ride over the past several years. The stock soared in early pandemic days, then fell over the past few years amid disappointment about declining vaccine sales. Then, in January, Moderna stock jumped 50% on optimism about a potential turnaround for the company.
Let's set the stock performance aside for a moment and consider the company's path. Moderna has reached a key transition point. The biotech company is building a seasonal vaccine franchise to support the growth of its broader pipeline -- now focused on oncology and rare diseases.
Moderna already sells two coronavirus vaccines and the RSV vaccine and aims to expand the seasonal offering with a flu vaccine. The U.S. Food and Drug Administration earlier this month said it wouldn't review the application of Moderna's flu candidate, citing the vaccine dosage used in the study's comparison arm. But after Moderna proposed a revised regulatory approach during a meeting with the agency, the FDA changed its stance. The FDA will review the flu candidate, and if all goes well, a vaccine may be launched in time for the upcoming flu season.
In a presentation earlier this year, Moderna said it expects seasonal vaccine sales growth to drive cash breakeven by 2028. The company also recently reiterated its forecast for as much as 10% revenue growth in the current year.
Meanwhile, Moderna continues to advance candidates in the pipeline, including a promising oncology vaccine in phase 3 studies.
Though Moderna was hit by a headwind just a few weeks ago when the FDA refused to review its flu application, this problem was short-lived. The regulatory environment remains tough, meaning this biotech still might face hurdles in the short term. But Moderna's long-term prospects look bright thanks to a full pipeline, including late-stage candidates. All of this means Moderna stock may not soar overnight, but it's a great investment for patient investors looking for a biotech company that has what it takes to excel over time.
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Adria Cimino has no position in any of the stocks mentioned. The Motley Fool has positions in and recommends Moderna. The Motley Fool has a disclosure policy.