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Moderna Inc (MRNA) RSS Feed

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Created
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Moderators DewDiligence Vexari axelvento



 

Professor files Human Rights complaint in bid to get Moderna vaccine for his children

  
https://ottawacitizen.com/news/local-news/professor-files-human-right-complaint-in-bid-to-get-moderna-vaccine-for-his-children




 

MRNA is a better Covid vaccine as compared to Pfizer


https://www.science.org/doi/10.1126/scitranslmed.abm2311

 

 mRNA-1273 COVID-19 vaccine Spontaneous tumor regression following COVID-19 vaccination.


https://jitc.bmj.com/content/10/3/e004371
 

MODERNA RECEIVES FDA AUTHORIZATION FOR EMERGENCY USE OF ITS COVID-19 VACCINE FOR CHILDREN 6 MONTHS OF AGE AND OLDER



https://investors.modernatx.com/news/news-details/2022/Moderna-Receives-FDA-Authorization-for-Emergency-Use-of-Its-COVID-19-Vaccine-for-Children-6-Months-of-Age-and-Older/default.aspx
 

MHRA approves the Moderna COVID-19 vaccine ‘Spikevax’ for use in 6 to 11-year olds


https://www.gov.uk/government/news/mhra-approves-the-moderna-covid-19-vaccine-spikevax-for-use-in-6-to-11-year-olds
 
 

HEALTH CANADA AUTHORIZES MODERNA'S COVID-19 VACCINE IN CHILDREN (6-11 YEARS)

 

ATAGI recommendations on the use of Spikevax (Moderna) COVID-19 vaccine in children aged 6 to 11 years


https://www.health.gov.au/news/atagi-recommendations-on-the-use-of-spikevax-moderna-covid-19-vaccine-in-children-aged-6-to-11-years

 

EMA recommends approval of Spikevax for children aged 6 to 11

https://www.ema.europa.eu/en/news/ema-recommends-approval-spikevax-children-aged-6-11


Dear fellow shareholders,

2021 was a year of monumental impact and change for Moderna 

Moderna entered 2021 with a strong cash position of approximately $5.25 billion. We have used this capital to invest in R&D and scale our development pipeline and manufacturing capabilities to maximize our impact on human health.

As we close our books for 2021, the company’s cash, cash equivalents and investments as of December 31, 2021, were more than $17 billion. We now have the resources to scale our investments and do even more to positively impact human health with mRNA medicines. This is just the beginning.

.

https://www.modernatx.com/newsroom/our-blog-coding-region/moderna-2021-shareholder-letter
 

Looking Ahead

Moderna is entering 2022 with a remarkable team poised to continue advancing mRNA vaccines and therapeutics into new areas for patients. We have a clear and exciting strategic path to do so, and a strong cash position. 

Priority one is our pan-respiratory annual single-dose booster vaccine. Respiratory viruses are a major cause of mortality worldwide, with an estimated 2.7 million deaths in 2015,2 and many millions more hospitalized and sick at home. Building on our continued focus on mRNA-1273, our COVID-19 vaccine, we want to prevent people who are at high risk (e.g., 50 years of age and older, healthcare workers, the immunocompromised) from being hospitalized due to respiratory infection. We will not stop until that goal is achieved.

Priority two is to go after the most important latent viruses and develop first-in-class vaccines against them. We want to protect our fellow human beings from suffering from the long-term damage caused by these viruses. Too many people have the quality of their health impacted because decades before, they were infected with a latent virus. We envision a world where vaccines against all the most important latent viruses are available to all.

 Priority three is to bring to market therapeutics based on mRNA-encoded proteins, like our current pipeline in oncology, cardiology, rare genetic diseases and autoimmune diseases.

Priority four is to bring to market innovative therapeutics based on mRNA-encoded gene editing enzymes.

We believe Moderna could become the most impactful healthcare company in the world. A strand of mRNA can bind science, technology and humanity together to build a healthier planet.

MODERNA ANNOUNCES FIRST PARTICIPANT DOSED IN PHASE 2/3 STUDY OF ITS MRNA RESPIRATORY SYNCYTIAL VIRUS (RSV) VACCINE

Moderna expects to enroll approximately 34,000 participants in multiple countries

RSV is a leading cause of severe respiratory illness in older adults (65+) and young children; there is no approved vaccine to prevent RSV

RSV illness in older adults results in an estimated $3 billion in annual medical costs in the U.S. each year
NOVEMBER, 18, 2021


https://investors.modernatx.com/news/news-details/2021/Moderna-Announces-First-Participant-Dosed-in-Phase-2-3-Study-of-its-mRNA-Respiratory-Syncytial-Virus-RSV-Vaccine/default.aspx

 

MODERNA ANNOUNCES FIRST PARTICIPANT DOSED IN PHASE 3 PIVOTAL REGISTRATION STUDY OF ITS MRNA CYTOMEGALOVIRUS (CMV) VACCINE
The Phase 3 study, known as CMVictory, will evaluate the safety and efficacy of mRNA-1647 against primary CMV infection in women ages 16-40 years. The Company will seek to enroll approximately 8,000 participants in the study, including 6,900 women of childbearing age, from approximately 150 sites globally, beginning in the U.S. Moderna has set a goal of enrolling a diverse group of U.S. participants into the study, including approximately 42% of participants who are Persons of Color. The ClinicalTrials.gov identifier is NCT05085366. To learn more about eligibility, please click here.
 



https://investors.modernatx.com/news/news-details/2021/Moderna-Announces-First-Participant-Dosed-in-Phase-3-Pivotal-Registration-Study-of-Its-mRNA-Cytomegalovirus-CMV-Vaccine-10-26-2021/default.aspx

 

MODERNA ANNOUNCES POSITIVE DATA FROM PHASE 2 STUDY OF MRNA VEGF-A THERAPEUTIC IN PATIENTS UNDERGOING CORONARY ARTERY BYPASS GRAFTING SURGERY

 



Phase 2a study met the primary endpoint of safety and tolerability; numerical trends observed in endpoints in the heart failure efficacy domains compared with placebo, including increase in LVEF and patient reported outcomes

Results support further investigation of AZD8601 for efficacy and safety in future larger studies

AZD8601 is being co-developed with AstraZeneca


https://investors.modernatx.com/news/news-details/2021/Moderna-Announces-Positive-Data-from-Phase-2-Study-of-mRNA-VEGF-A-Therapeutic-in-Patients-Undergoing-Coronary-Artery-Bypass-Grafting-Surgery-11-15-2021/default.aspx

 

MODERNA AND CARISMA ESTABLISH COLLABORATION TO DEVELOP IN VIVO ENGINEERED CHIMERIC ANTIGEN RECEPTOR MONOCYTES (CAR-M) FOR ONCOLOGY
 

Collaboration will combine Carisma's engineered macrophage technology with Moderna's mRNA and LNP technologies to generate and develop in vivo CAR-M therapeutics

Multi-year research collaboration funded by Moderna with options for up to twelve targets

Carisma to receive $45 million up-front cash payment and investment by Moderna in the form of a $35 million convertible note

Carisma eligible to receive milestone and royalty payments

 

https://investors.modernatx.com/news/news-details/2022/Moderna-and-Carisma-Establish-Collaboration-to-Develop-in-vivo-Engineered-Chimeric-Antigen-Receptor-Monocytes-CAR-M-for-Oncology/default.aspx
 

MODERNA ANNOUNCES PRESENTATION OF INTERIM DATA FROM PHASE 1 STUDY OF MRNA TRIPLET PROGRAM AT 2021 SITC ANNUAL MEETING

“We are encouraged by the interim data from our Triplet program, which combines three mRNAs into one therapy injected directly into the tumor.


https://investors.modernatx.com/news/news-details/2021/Moderna-Announces-Presentation-of-Interim-Data-from-Phase-1-Study-of-mRNA-Triplet-Program-at-2021-SITC-Annual-Meeting-11-12-2021/default.aspx

 

IAVI AND MODERNA LAUNCH TRIAL OF HIV VACCINE ANTIGENS DELIVERED THROUGH MRNA TECHNOLOGY

 January 27, 2022 / IAVI, the nonprofit scientific research organization, and biotechnology company Moderna announced today that first doses have been administered in a clinical trial of experimental HIV vaccine antigens at George Washington University (GWU) School of Medicine and Health Sciences in Washington, D.C.
https://investors.modernatx.com/news/news-details/2022/IAVI-and-Moderna-Launch-Trial-of-HIV-Vaccine-Antigens-Delivered-Through-mRNA-Technology/default.aspx

MODERNA ANNOUNCES FIRST PARTICIPANT DOSED IN PHASE 1 STUDY OF ITS MRNA EPSTEIN-BARR VIRUS (EBV) VACCINE

Moderna expects to enroll approximately 270 participants in the U.S.

EBV is a major cause of infectious mononucleosis, which can debilitate patients for weeks to months; there is no approved vaccine to prevent EBV

EBV can also lead to lifelong medical conditions and is associated with an increased risk of developing multiple sclerosis, certain lymphoproliferative disorders, cancers, and autoimmune diseases

Moderna now has a portfolio of two vaccines against latent viruses in the clinic: CMV and EBV
 


https://investors.modernatx.com/news/news-details/2022/Moderna-Announces-First-Participant-Dosed-in-Phase-1-Study-of-its-mRNA-Epstein-Barr-Virus-EBV-Vaccine/default.aspx

 

MODERNA RECEIVES FULL U.S. FDA APPROVAL FOR COVID-19 VACCINE SPIKEVAX

JANUARY, 31, 2022
 

Approval based on a comprehensive submission package including efficacy and safety data approximately six months after second dose

SPIKEVAX has received approval by regulators in more than 70 countries, including Canada, Japan, the European Union, the UK, Israel

807 million doses of Moderna's COVID-19 vaccine shipped globally in 2021; approximately 25% of those doses shipped to low- and middle-income countries



https://investors.modernatx.com/news/news-details/2022/Moderna-Receives-Full-U.S.-FDA-Approval-for-COVID-19-Vaccine-Spikevax/default.aspx

 

Coronavirus (COVID-19) Update: FDA Takes Key Action by Approving Second COVID-19 Vaccine


https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-takes-key-action-approving-second-covid-19-vaccine

 




 

Q4 2021 revenues of $7.2 billion; GAAP net-income of $4.9 billion and GAAP diluted EPS of $11.29

Full year 2021 revenues of $18.5 billion; GAAP net-income of $12.2 billion and GAAP diluted EPS of $28.29

Moderna increased its 2022 signed advance purchase agreements to approximately $19 billion, with additional signed options of approximately $3 billion; numerous discussions ongoing with governments for the fall of 2022 and 2023

Moderna received full U.S. FDA approval for COVID-19 vaccine, Spikevax

Moderna announces new bivalent booster candidate (mRNA-1273.214) combining Omicron-specific booster candidate (mRNA-1273.529) and the Moderna COVID-19 vaccine (mRNA-1273)

Company now has 44 programs in development

Moderna announces a new $3 billion share repurchase plan

https://investors.modernatx.com/news/news-details/2022/Moderna-Reports-Fourth-Quarter-and-Fiscal-Year-2021-Financial-Results-and-Provides-Business-Updates/default.aspx



MODERNA ANNOUNCES MEMORANDUM OF UNDERSTANDING WITH THE GOVERNMENT OF THE REPUBLIC OF KENYA TO ESTABLISH ITS FIRST MRNA MANUFACTURING FACILITY IN AFRICA
 

Facility to manufacture drug substance with opportunity for fill/finish and packaging capabilities

Moderna investing up to $500 million to produce up to 500 million doses each year for the African continent

Moderna will invest in building mRNA capabilities in Africa

https://investors.modernatx.com/news/news-details/2022/Moderna-Announces-Memorandum-of-Understanding-with-the-Government-of-the-Republic-of-Kenya-to-Establish-its-First-mRNA-Manufacturing-Facility-in-Africa/default.aspx


 

MODERNA ANNOUNCES FIRST PARTICIPANT DOSED IN PHASE 1 STUDY OF ITS HIV TRIMER MRNA VACCINE




  





 

 
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