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    MRNA   US60770K1079

MODERNA, INC.

(MRNA)
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Moderna : in talks with FDA to expand COVID-19 vaccine pediatric study

07/26/2021 | 01:56pm EDT

July 26 (Reuters) - Moderna Inc is in talks with U.S. regulators to expand the size of an ongoing trial testing its COVID-19 vaccines in children aged between five and 11, the drugmaker said on Monday.

The objective of the discussion with the U.S. Food and Drug Administration is to enroll a larger safety database, which increases the likelihood of detecting rarer events, the company said.

Moderna expects to have a package that supports authorization in winter of 2021 or early 2022, a company spokesperson told Reuters.

Earlier in the day, the New York Times reported the U.S. regulators have asked Pfizer Inc-BioNTech and Moderna to expand the size of the trial.

They claimed the strength of the studies was inadequate to detect the rare side effects, including myocarditis, an inflammation of the heart muscle and pericarditis, an inflammation of the lining around the heart, the report said.(https://nyti.ms/3xgzuWZ)

Pfizer said it has not provided any updates to its previously stated timelines. It had previously said it expects to have data for children aged between 5 and 11 in September.

The health regulator has asked the companies to include 3,000 children in their trials, almost double the original number of study participants, the NYT report said, citing people familiar with the matter.

FDA did not immediately respond to Reuters request for comment. (Reporting by Mrinalika Roy in Benagluru and Michael Erman in New Jersey; Editing by Shinjini Ganguli)


ę Reuters 2021
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Analyst Recommendations on MODERNA, INC.
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Financials (USD)
Sales 2021 20 333 M - -
Net income 2021 12 514 M - -
Net cash 2021 12 947 M - -
P/E ratio 2021 13,8x
Yield 2021 -
Capitalization 165 B 165 B -
EV / Sales 2021 7,48x
EV / Sales 2022 6,77x
Nbr of Employees 1 300
Free-Float 90,3%
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Moderna, Inc. Technical Analysis Chart | MRNA | US60770K1079 | MarketScreener
Technical analysis trends MODERNA, INC.
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Income Statement Evolution
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Mean consensus HOLD
Number of Analysts 16
Last Close Price 408,84 $
Average target price 307,77 $
Spread / Average Target -24,7%
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Managers and Directors
StÚphane Bancel Chief Executive Officer & Director
Stephen Hoge President
David W. Meline Chief Financial Officer
Noubar B. Afeyan Chairman
Juan Andres Chief Technical Operations & Quality Officer
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