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Novavax (NVAX) has said it will not ask the Food and Drug Administration to clear its Covid vaccine until the end of the year, and the stock of NVAX fell on Friday.
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This is the third deadline for the Novavax vaccine. Previously, the biotech company said it would seek emergency use authorization in the US, UK and Europe in the third quarter. Now, Novavax says it will submit its application to the FDA “in the fourth quarter of 2021”.
In addition, Novavax recorded a larger loss than expected in the second quarter. For the period, Novavax lost $ 4.75 per share, while analysts called only a loss of $ 3.63 per share. Revenue – which is tied to development deals – rose 728% to $ 298 million, but missed views to $ 387.9 million.
In morning stock exchange trading today, NVAX stock fell 15.2% to near 200.30.
NVAX stock collapses with delay
Novavax said it remains on track to seek UK clearance for the Covid vaccine during the third quarter. It also plans to complete filings in mainland Europe, Australia, Canada and New Zealand “within weeks” of the UK’s bid. This month, the company plans to apply for membership with the World Health Organization.
The company has already completed its regulatory applications in India, Indonesia and the Philippines.
Novavax said it is working with the FDA to finalize its package in the United States. On the earnings conference call with analysts, managing director Stanley Erck said “all the components are in place to complete our case in the fourth quarter.” But NVAX stock reversed a four-day winning streak after Friday’s opening.
Still, that would put Novavax about a year behind schedule Pfizer (PFE) /BioNTech (BNTX) and Modern (MRNA), which manufacture two-dose vaccines using messenger RNA technology. A single dose vaccine of Johnson & johnson (JNJ) uses a deactivated adenovirus to deliver instructions to the body. The FDA cleared it in February.
“We still don’t have an approved protein vaccine for example,” Erck said on the call. “And there are some people (for whom) this could be a very good alternative.”
Despite the regulatory delay in the United States, Novavax said it was on track to reach a capacity of 100 million doses per month by the end of the third quarter. He expects to reach 150 million doses per month by the end of the fourth quarter.
Highly listed biotech stocks
NVAX stock fell to its 50-day moving average on Friday, according to MarketSmith.com.
However, the stocks have a strong relative strength rating of 91. This places the NVAX stock in the top 9% of all stocks in terms of 12-month performance, according to IBD Digital.
Follow Allison Gatlin on Twitter at @IBD_AGatlin.
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