Is This a Setback for Moderna?

Investors have put their hopes in 's (NASDAQ: MRNA) next potential product, a respiratory syncytial virus (RSV) vaccine. That's because it represents a new revenue stream for a company that until now has relied on just one product, and a product struggling with declining demand: The coronavirus vaccine. Once the source of more than $18 billion in annual revenue, the vaccine is now bringing in considerably less -- $6.7 billion last year -- as fewer people seek vaccination.

The RSV vaccine promises to become another blockbuster, and one that could deliver high-level revenue steadily year after year. A potential approval will also show that Moderna isn't just a one-product company and instead can build a billion-dollar respiratory vaccine portfolio, including several game-changing products.

But news last week disappointed investors, who were expecting a regulatory decision on the RSV candidate by May 12. Moderna said the U.S. Food and Drug Administration (FDA) wouldn't be able to make that deadline and that it required a few more weeks to consider the application. As a result, Moderna stock slipped about 5% in one trading session. Is the FDA delay a setback for the biotech company? Let's find out.

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Source Fool.com