Novavax (NVAX) said it won’t ask the Food and Drug Administration to authorize its Covid vaccine until late this year, and NVAX stock tanked Friday.
This is the third timeline delay for the Novavax vaccine. Previously, the biotech company said it would seek emergency use authorization in the U.S., U.K. and Europe in the third quarter. Now, Novavax says it will submit its FDA request “in the fourth quarter of 2021.”
Further, Novavax posted a wider-than-expected loss in the second quarter. For the period, Novavax lost $4.75 per share, while analysts only called for a $3.63 per-share loss. Revenue — which is tied to development agreements — grew 728% to $298 million, but missed views for $387.9 million.
NVAX Stock Slumps On Delay
Novavax said it remains on track to ask the U.K. for Covid vaccine authorization during the third quarter. It also plans to wrap filings in continental Europe, Australia, Canada and New Zealand “within weeks” of the U.K. submission. This month, the company plans to ask for a listing from the World Health Organization.
The company has already finished its regulatory requests in India, Indonesia and the Philippines.
Novavax said it’s working with the FDA to finalize its package in the U.S. On the earnings conference call with analysts, Chief Executive Stanley Erck said “all the components are in place to achieve our filing within the fourth quarter.” But NVAX stock reversed a four-day winning spree after the open Friday.
Still, that would put Novavax roughly a year behind Pfizer (PFE)/BioNTech (BNTX) and Moderna (MRNA), which make two-dose vaccines that use messenger RNA technology. A single-dose vaccine from Johnson & Johnson (JNJ) uses a disabled adenovirus to deliver instructions to the body. The FDA authorized it in February.
“We still don’t have an approved protein-based vaccine for instance,” Erck said on the call. “And there are some people (for whom) that might be a very good alternative.”
Despite the regulatory delay in the U.S., Novavax said it’s on track to achieve capacity of 100 million doses per month by the end of the third quarter. It expects to hit 150 million doses per month by the end of the fourth quarter.
Highly Rated Biotech Stock
On Friday, NVAX stock sank toward its 50-day moving average, according to MarketSmith.com.
Shares have a strong Relative Strength Rating of 91, however. That puts 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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