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    MRNA   US60770K1079

MODERNA, INC.

(MRNA)
  Report
Real-time Estimate Cboe BZX  -  11:20:30 2023-03-28 am EDT
147.57 USD   -0.53%
03/24Insider Sell: Moderna
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03/23Sector Update: Health Care Stocks Mixed During Late Afternoon
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03/23Moderna, Generation Bio Working Together to Develop Non-Viral Genetic Medicines
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Moderna Gets FDA Breakthrough Designation for RSV Vaccine Candidate

01/30/2023 | 07:53am EDT

By Colin Kellaher


Moderna Inc. on Monday said the U.S. Food and Drug Administration granted breakthrough-therapy designation to its mRNA-1345 investigational vaccine candidate for respiratory syncytial virus, or RSV.

The Cambridge, Mass., vaccine maker said the designation covers mRNA-1345 for the prevention of RSV-associated lower respiratory tract disease in adults ages 60 and older.

The FDA's breakthrough-therapy designation aims to expedite the development and review of a drug for serious conditions when preliminary clinical evidence shows the drug may show substantial improvement over available therapies.

Moderna said mRNA-1345, which uses the same messenger RNA technology as its blockbuster Covid-19 vaccines, won the designation based on positive topline data from a Phase 3 study that showed vaccine efficacy of 83.7% against RSV lower respiratory tract disease, defined by two or more symptoms in older adults.

The company said it plans to file for FDA approval of the vaccine in the first half of the year.

RSV, a common respiratory virus that people get many times over the course of their lives, can cause serious illness in the very old and young. There are currently no FDA-approved prophylactic, therapeutic or vaccine options for RSV for older adults.

Moderna rival Pfizer Inc. in December said the FDA had granted priority review with a target action date in May for its RSV vaccine candidate for the prevention of lower respiratory tract disease in older adults.


Write to Colin Kellaher at colin.kellaher@wsj.com


(END) Dow Jones Newswires

01-30-23 0753ET

Stocks mentioned in the article
ChangeLast1st jan.
MODERNA, INC. -0.58% 147.42 Delayed Quote.-17.41%
PFIZER, INC. -0.35% 40.07 Delayed Quote.-21.51%
All news about MODERNA, INC.
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03/23Generation Bio Co. announced that it expects to receive $36 million in funding from Mod..
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03/22Moderna CEO defends $130 COVID vaccine price
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03/22Moderna CEO defends $130 COVID vaccine price
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Analyst Recommendations on MODERNA, INC.
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Financials (USD)
Sales 2023 7 636 M - -
Net income 2023 -954 M - -
Net cash 2023 8 571 M - -
P/E ratio 2023 -65,3x
Yield 2023 -
Capitalization 57 215 M 57 215 M -
EV / Sales 2023 6,37x
EV / Sales 2024 7,52x
Nbr of Employees 3 900
Free-Float 90,0%
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Technical analysis trends MODERNA, INC.
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Income Statement Evolution
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Mean consensus OUTPERFORM
Number of Analysts 20
Last Close Price 148,35 $
Average target price 221,94 $
Spread / Average Target 49,6%
EPS Revisions
Managers and Directors
StÚphane Bancel Chief Executive Officer & Director
Stephen Hoge President
James M. Mock Chief Financial Officer
Noubar B. Afeyan Chairman
Paul Burton Chief Medical Officer
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