Eli Lilly and Co
Change company Symbol lookup
Select an option...
LLY Eli Lilly and Co
INTC Intel Corp
DVN Devon Energy Corp
CCL Carnival Corp
OKE ONEOK Inc
BMY Bristol-Myers Squibb Co
KO Coca-Cola Co
DOW Dow Inc
CTVA Corteva Inc
COP Conocophillips
Go

Health Care : Pharmaceuticals | Large Cap Growth
Company profile

Eli Lilly and Company is engaged in a drug manufacturing business. The Company discovers, develops, manufactures, and markets products in the human pharmaceutical products segment. Its diabetes products include Basaglar, Humalog, Humulin, Jardiance, Trajenta, and Trulicity. Its oncology products consist of Alimta, Cyramza, Erbitux, Retevmo, Tyvyt, and Verzenio. Its immunology products include Olumiant, Baricitinib, and Taltz. Its neuroscience products include Cymbalta, Emgality, and Zyprexa. Its other therapies consist of Bamlanivimab and etesevimab, Bebtelovimab, Cialis, and Forteo. It maintains special business groups to service wholesalers, pharmacy benefit managers, managed care organizations, group purchasing organizations, government and long-term care institutions, hospitals, and certain retail pharmacies. It manufactures and distributes its products through facilities in the United States, including Puerto Rico, and other countries. Its products are sold in about 120 countries.

Closing Price
$365.25
Day's Change
3.53 (0.98%)
Bid
--
Ask
--
B/A Size
--
Day's High
365.83
Day's Low
361.55
Volume
(Light)
Volume:
1,039,094

10-day average volume:
3,176,973
1,039,094

European Medicines Agency Accepts Moderna's Conditional Marketing Authorization Filing for its Omicron BA.4/BA.5 Targeting Bivalent COVID-19 Vaccine

4:50 am ET September 28, 2022 (Accesswire) Print

Filing follows approval of Spikevax bivalent Original/Omicron BA.1 (mRNA-1273.214), a bivalent booster vaccine targeting the Omicron BA.1 subvariant, in September

Moderna's Omicron-targeting bivalent boosters now authorized in the United States, Australia, Canada, Europe, Japan, South Korea, Switzerland, Singapore, Taiwan, and the UK

CAMBRIDGE, MA / ACCESSWIRE / September 28, 2022 /Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the European Medicines Agency (EMA) has accepted a variation for the evaluation of a 50 µg booster dose of the Omicron-containing bivalent COVID booster candidate, mRNA-1273.222 (Spikevax bivalent Original/Omicron BA.4-5) in adults 12 years and older. Spikevax bivalent Original/Omicron BA.4-5 is a next-generation bivalent vaccine that contains 25 µg of mRNA-1273 (Spikevax) and 25 µg of a vaccine candidate targeting the Omicron variant of concern (BA.4/BA.5).

"We are proud to announce this filing for the use of our bivalent COVID-19 vaccine targeting the BA.4/BA.5 Omicron subvariants in the European Union," said Stéphane Bancel, Chief Executive Officer of Moderna. "Following the recent approval of our BA.1 targeting vaccine in Europe, our BA.4/BA5 Omicron targeting vaccine will now bring a second option to help protect people across Europe as we head into the winter months."

mRNA-1273.222 targets both the original strain of SARS-CoV-2 as well as the BA.4/BA.5 subvariants of the Omicron strain. Moderna's submission to the EMA is based on preclinical data for mRNA-1273.222 as well as clinical trial data from a Phase 2/3 studying Spikevax bivalent Original/Omicron BA.1 (mRNA-1273.214), a bivalent booster vaccine targeting the Omicron BA.1 subvariant, which recently received EMA approval.

Moderna has received authorizations for Omicron-targeting bivalent boosters in the United States, Australia, Canada, Europe, Japan, South Korea, Switzerland, Singapore, Taiwan, and the UK to date and has submitted regulatory applications worldwide.

About Moderna

In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.

Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and auto-immune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including regarding: the potential authorization by European Union health officials of an mRNA-1273.222 booster dose in adults 12 years of age and older; the potential for mRNA-1273.222 to provide protection from COVID-19, including emerging variants; and Moderna's global regulatory applications. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include those other risks and uncertainties described under the heading "Risk Factors" in Moderna's Annual Report on Form 10-K for the fiscal year ended December 31, 2021 and Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2022, each filed with the U.S. Securities and Exchange Commission (SEC), and in subsequent filings made by Moderna with the SEC, which are available on the SEC's website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date hereof.

Moderna Contacts:

Media:

Luke Mircea Willats

Director, Corporate Communications

Luke.Mirceawillats@modernatx.com

Investors:

Lavina Talukdar

Senior Vice President & Head of Investor Relations

617-209-5834

Lavina.Talukdar@modernatx.com

SOURCE: Moderna, Inc.





View source version on accesswire.com:

https://www.accesswire.com/717785/European-Medicines-Agency-Accepts-Modernas-Conditional-Marketing-Authorization-Filing-for-its-Omicron-BA4BA5-Targeting-Bivalent-COVID-19-Vaccine



comtex tracking

COMTEX_415457458/2457/2022-09-28T04:50:12

Earnings Calendar and Events Data provided by |Terms of Use| © 2022 Wall Street Horizon, Inc.

Market data accompanied by is delayed by at least 15 minutes for NASDAQ, NYSE MKT, NYSE, and options. Duration of the delay for other exchanges varies.
Market data and information provided by Morningstar.

Options are not suitable for all investors as the special risks inherent to options trading may expose investors to potentially rapid and substantial losses.
Please read Characteristics and Risks of Standard Options before investing in options.

Information and news provided by ,, , Computrade Systems, Inc., ,, and

Copyright © 2022. All rights reserved.