Shares of Pfizer and BioNTech rose in Thursday’s extended market session after an advisory panel to the US Food and Drug Administration (FDA) voted in favor of approving the emergency use of their mRNA vaccine candidate, BNT162b2, against COVID-19.
Pfizer (PFE) rose 2.8% and BioNTech gained 3.4% in after-market trading.
Specifically, the so-called Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 17 to 4 in favor of the FDA granting Emergency Use Authorization (EUA) for the companies’ COVID-19 vaccine. Alhtough the vote is not binding, it is widely anticipated that the FDA will adopt the VRBAC’s recommendation for EUA approval in the coming days. If authorized, BNT162b2 would be the first COVID-19 vaccine available in the US. This week, the UK rolled out and started to supply the mRNA vaccine after becoming the first country to approve the COVID-19 vaccine.
“We have been looking forward to presenting our robust data package to the committee of vaccine experts for the US government since we began our efforts to develop a novel COVID-19 vaccine earlier this year,” said Pfizer CO Albert Bourla. “We are pleased with the committee’s strong majority vote, and if the FDA issues an authorization, stand at the ready to bring this vaccine to people in the US in an effort to help combat this devastating pandemic.”
Pfizer and BioNTech (BNTX) have previously confirmed that they have a combined manufacturing network for the supply of up to 50 million vaccine doses globally in 2020 and up to 1.3 billion doses by the end of 2021.
The VRBAC’s decision was based on the safety and efficacy data from an ongoing phase 3 randomized, double-blinded and placebo-controlled trial of BNT162b2 in about 44,000 participants. The Phase 3 data showed a vaccine efficacy rate of 95% in participants without prior SARS-CoV-2 infection and also in participants with and without prior SARS-CoV-2 infection, in each case measured from 7 days after the second dose. No serious safety concerns related to the vaccine were reported. Efficacy was consistent across age, gender, race and ethnicity demographics.
Commenting on the FDA panel vote, J.P. Morgan analyst Cory Kasimov said that he was not surprised by the overall support or the fact that there are still many unknowns around the data.
Kasimov added that he expects the FDA emergence use authorization imminently “post the panel’s rubber stamp.”
However, the analyst stuck to his Hold rating on BNTX, as the “Bigger picture, the possibility of multiple future COVID-19 vaccines (some at potentially much cheaper prices) and the uncertain duration of pandemic leave us relatively cautious on the substantial amount of value that the market is already ascribing to BNT162b2.” (See BioNTech stock analysis on TipRanks).
Meanwhile, the rest of the Street is cautiously optimistic on the stock with a Moderate Buy analyst consensus, which is divided between 3 Buys and 4 Holds. With BNTX shares up a whopping 282% so far this year, analysts now forecast downside potential of 14% lies ahead over the coming year, setting the average price target at $111.17.
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Ciena Corp. reported lower-than-expected 4Q earnings and announced the resumption of it share repurchase plan. Shares of the telecommunication networking equipment and software services provider fell 2.3% on Thursday.
Ciena’s (CIEN) adjusted earnings of $0.60 per share fell short of analysts’ expectations of $0.63 and compared to EPS of $0.58 in the year-ago period. Fourth-quarter revenues declined 14.4% to $828.5 million year-on-year, but surpassed Street estimates of $825.3 million.
"Our fiscal fourth quarter and full-year 2020 performance reported today demonstrates that we have the innovation, diversification and global scale to perform well in a challenging environment," said Gary Smith, Ciena CEO.
Ciena announced that it will resume its share repurchase program in the first-quarter of fiscal 2021. The company has a buyback plan worth $150 million. (See CIEN stock analysis on TipRanks).
Following its earnings release, Needham analyst Alex Henderson reiterated his Buy rating and a price target of $58 (25.8% upside potential). In a note to investors, Henderson wrote, “We think the recovery will start in the Spring and accelerate as Huawei replacement and 800G drive share gains. We view this as a good time to enter CIEN shares in anticipation of these improvements.”
Meanwhile, the Street has a cautiously optimistic outlook on the stock. The Moderate Buy analyst consensus is based on 2 Buys and 3 Holds. The average price target stands at $48.30 and implies upside potential of about 4.8% to current levels. Shares have plunged about 8% year-to-date.
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Costco posted better-than-expected earnings in the first quarter of fiscal 2021 (ended Nov. 22) as the retail giant continues to experience strong demand for groceries and household essentials amid the COVID-19 pandemic.
The company’s 1Q revenue grew 16.7% year-over-year to $43.2 billion and came ahead of analysts’ forecast of $42.3 billion. Costco’s (COST) net sales were up 16.9% to $42.4 billion while membership fees increased 7% to $861 million. Comparable sales growth came in at 15.4%. E-commerce sales surged 86.4% as online purchases continued to be robust amid the current health crisis.
The retailer reported strong sales in core categories like food and sundries, hardlines, softlines, fresh food and pharmacy. Meanwhile, it experienced softer sales trends in ancillary and travel businesses.
Costco’s 1Q EPS grew about 38% to $2.62 driven by higher sales and improved operating margin. Excluding one-time items, the company’s adjusted EPS of $2.29 exceeded analysts’ expectations of $2.04. (See COST stock analysis on TipRanks)
Following the print, Oppenheimer analyst Rupesh Parikh reiterated a Buy rating on the stock with a price target of $400. The analyst noted that Costco exceeded estimates despite “very generous hazard pay.”
“Looking forward, we believe COST remains best positioned to retain share gains in key categories from food to home-related categories such as appliances and furniture coming out of the pandemic. COST remains a top pick for us, and we would take advantage of a likely volatile trade in coming quarters as the company laps more difficult compares,” Parikh added.
Currently, Costco scores a Strong Buy analyst consensus based on 15 Buys and 4 Holds. With shares rising 30.1% year-to-date, the average price target of $393.56 indicates upside potential of 5.6% from current levels.
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