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Highlights
- Moderna, Inc. (MRNA) received full FDA approval for Spikevax.
- The vaccine approval is for people aged 18 years and older.
- The stock surged more than 4.5% in the intraday session.
The Moderna, Inc. (NASDAQ:MRNA) stock surged more than 4.5% to around US$164.3 on Monday afternoon after it announced receiving full approval for its Covid-19 booster dose Spikevax from the US Food and Drug Administration (FDA).
The FDA approved the Biologics License Application (BLA) for Spikevax, a Covid-19 drug for 18 years and older. The vaccine has been authorized under Emergency Use Authorization (EUA).
Under the emergency authorization, a 50-microgram booster dose and a third dose of 100 micrograms were authorized for 18 years and older.
The Spikevax has been approved in more than 70 countries, including the UK, Canada, Japan, Israel, and Europe.
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Moderna CEO Stéphane Bancel said: "It is a momentous milestone in Moderna's history as it is our first product to achieve licensure in the US." He thanked FDA for a thorough review of the application and said the company is "humbled" by Spikevax's role in helping end the pandemic.
In 2021, the company shipped 807 million Covid-19 vaccines worldwide, of which 25% were supplied to low-income and middle-income countries.
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About the company
The Cambridge, Massachusetts-based Moderna Inc is a commercial-stage biotechnology company. It was founded in 2010 and went public in December 2018. Its mRNA technology was authorized in December 2020 in the US.
The company has a market capitalization of US$66.9 billion, with a P/E ratio of 10.13, and a forward P/E for one year is 5.98.
The stock traded in the range of US$497.49 to US$117.34 in the last 52 weeks.
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Financials
For the nine months ended September 30, 2021, the company earned revenue of US$11.26 billion compared to US$0.232 billion in the corresponding period of 2020.
Its net income was US$7.33 billion or US$17.00 per share diluted compared to a net loss of US$0.474 billion or US$(1.26) per share diluted in the nine months ended September 30, 2020.
Its cash and equivalents were US$5.55 billion as of September 30, 2021, compared to US$1.51 billion as of September 30, 2020.
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Bottomline
The Nasdaq Biotechnology Index fell 19.24% in one year, while Moderna slid 7.91% in the same period. Analysts believe the industry has tremendous growth potential with robust demand due to covid. However, investors should apply due diligence before investing in stocks.
