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MarketScreener Homepage  >  Equities  >  Nasdaq  >  Moderna, Inc.    MRNA

MODERNA, INC.

(MRNA)
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Pfizer, BioNTech's coronavirus vaccine candidates get FDA's 'fast track' status

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07/13/2020 | 07:23am EDT

July 13 (Reuters) - Pfizer Inc and partner BioNTech SE said on Monday two of their experimental coronavirus vaccine candidates received "fast track" status from the U.S. Food and Drug Administration, which is designed to speed up the regulatory review process.

The U.S.-listed shares of the German firm climbed about 15%, while Pfizer's stock rose about 5%. The news lifted broader market sentiment as investors cheered signs of progress in COVID-19 vaccine development.

The FDA grants fast track status to speed up the review of new drugs and vaccines that show the potential to address unmet medical needs.

The market is "desperate to latch onto any positive developments in the vaccine field," JP Morgan analyst Cory Kasimov said in a note.

However, Kasimov said, the update was not really surprising or significant, noting that the designation "does not speak to the potential of a particular candidate."

The benefits of the designation "are almost certainly going to be granted to all potential COVID-19 therapeutics/vaccines anyway," Kasimov wrote.

The two candidates to win the designation, BNT162b1 and BNT162b2, are the most advanced of the at least four vaccines being assessed by the companies in ongoing trials in the United States and Germany.

Earlier this month, Pfizer and BioNTech said early-stage testing of two dosages of BNT162b1 on 24 healthy volunteers showed that after 28 days they had developed higher levels of COVID-19 antibodies than typically seen in infected people.

The companies said they expect to start a large trial with up to 30,000 participants as soon as later this month, upon regulatory approval.

They are gearing up to make up to 100 million doses by the end of this year and potentially more than 1.2 billion doses by end of 2021, if the vaccine is successful.

The companies are in a global race with Moderna Inc , AstraZeneca Plc and others to develop a vaccine for COVID-19, the respiratory illness caused by the new coronavirus, which has claimed over 568,500 lives globally, according to a Reuters tally.

Moderna, which is developing a potential vaccine using similar technology as Pfizer/BioNTech, won the same fast-track status for its COVID-19 vaccine candidate in May.

(Reporting by Manas Mishra and Manojna Maddipatla in Bengaluru, additional reporting by Ankur Banerjee; Editing by Shinjini Ganguli, Sriraj Kalluvila, Lewis Krauskopf and Richard Chang)

Stocks mentioned in the article
ChangeLast1st jan.
ASTRAZENECA PLC 0.21% 8470 Delayed Quote.10.67%
BIONTECH SE 1.31% 78.04 Delayed Quote.127.51%
MODERNA, INC. 0.85% 74.3401 Delayed Quote.277.10%
PFIZER LIMITED -0.20% 4382 End-of-day quote.3.74%
PFIZER, INC. 0.31% 38.39 Delayed Quote.-2.32%
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Financials (USD)
Sales 2020 330 M - -
Net income 2020 -542 M - -
Net cash 2020 2 228 M - -
P/E ratio 2020 -50,9x
Yield 2020 -
Capitalization 28 680 M 28 680 M -
EV / Sales 2020 80,2x
EV / Sales 2021 5,38x
Nbr of Employees 850
Free-Float 79,7%
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Mean consensus OUTPERFORM
Number of Analysts 16
Average target price 91,63 $
Last Close Price 73,76 $
Spread / Highest target 81,7%
Spread / Average Target 24,2%
Spread / Lowest Target -18,7%
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Managers
NameTitle
Stéphane Bancel Chief Executive Officer & Director
Stephen Hoge President
Noubar B. Afeyan Chairman
David W. Meline Chief Financial Officer
Juan Andres Chief Technical Operations & Quality Officer
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