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Moderna

Moderna, Inc. engages in the development of transformative medicines based on messenger ribonucleic acid (mRNA). Its product pipeline includes the following modalities: prophylactic vaccines, cancer vaccines, intratumoral immuno-oncology, localized regenerative therapeutics, systemic secreted therapeutics, and systemic intracellular therapeutics. The company was founded by Noubar B. Afeyan, Robert S. Langer, Jr., Derrick J. Rose and Kenneth R. Chien in 2010 and is headquartered in Cambridge, MA.

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Moderna reports robust earnings, eyes growth through innovative vaccines

Moderna's strong financial performance and strategic investments in R&D and commercial activities position it well for future growth. While facing challenges in product sales and regulatory uncertainties, the company's focus on innovation and expanding its product portfolio presents opportunities for continued success in the healthcare sector.

Moderna posts strong Q1 earnings, eyes market expansion opportunities

Moderna's Q1 performance reflects strong earnings, robust R&D investments, and strategic commercial negotiations.
The company's strengths lie in market positioning, cost optimization, asset prioritization, and collaboration opportunities.
Challenges include contract timing uncertainties, market competition, and regulatory approval processes.
Amidst challenges, Moderna sees opportunities in revenue growth, market expansion, program advancements, and partnership developments.

Moderna reports Q2 performance, innovation strength, margin challenges

Moderna's Q2 performance reflects significant investments and revised COVID-19 sales expectations.
The company's strengths lie in innovation, oncology progress, and preparations for upcoming product launches.
Challenges include margin guidance revisions and differing views on vaccine development strategies.
Opportunities exist in vaccine combinations, market positioning, and accelerated enrollment in flu studies.

Moderna reports $1.8B Spikevax sales, eyes profitability in 2024

Moderna's Q3 2023 Earnings Call highlighted strong Spikevax sales, plans for new vaccine launches, and a focus on profitability. Despite challenges like restructuring charges, the company sees opportunities in expanding its product portfolio and market share.

Moderna reports $6.1B in 2023 sales, anticipates $4B in 2024

Moderna's financials reflect market transition impact with a focus on cost management.
Strong pipeline progress and confidence in vaccine efficacy milestones for 2024.
Challenges include net loss, anticipated sales decrease, and ongoing regulatory discussions.
Opportunities lie in potential vaccine approvals, partnerships, and therapeutic advancements.

Moderna reports Q1 sales dip, eyes growth in pipeline

Moderna's Q1 2024 performance reflects a shift in sales dynamics with a focus on pipeline progress and financial discipline.
While facing challenges in market dynamics and transparency, Moderna's strategic focus on COVID-19 and pipeline advancements positions it for growth.
Opportunities lie in expanding vaccine delivery methods, international market penetration, and therapeutic advancements in various programs.

Moderna reports robust Q2 earnings, focuses on innovation and cost management

Moderna's Q2 2024 earnings call highlighted strong financial performance, strategic achievements in vaccine development, and operational improvements. While facing challenges in sales and competitive pressures, the company remains focused on innovation and cost management. Opportunities lie in upcoming milestones and the potential of its diverse clinical programs.

Moderna reports robust Q3 earnings, eyes global expansion and innovation

Moderna's Q3 2024 earnings call showcased strong financial performance, cost-saving initiatives, and a robust pipeline of products in development.
While facing legal challenges and market competition, the company's strategic strengths lie in market share, global expansion plans, and financial stability.
Opportunities in education, international markets, and product development position Moderna for continued growth and innovation in the healthcare sector.
Navigating challenges and leveraging opportunities will be key for Moderna to maintain its leadership in the COVID vaccine market and drive future success.

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Moderna will be seeking regulatory approval for its young children's COVID-19 vaccines, ahead of Pfizer.

Recovery Is Possible As Moderna Races Its Children Vaccine

Moderna's (MRNA) COVID-19 vaccine, mRNA-1273, generates robust neutralizing antibody response in a phase II/III study evaluating it in children.

Moderna (MRNA) to File EUA for Use of mRNA-1273 in Children

"You have people that are younger adults that have comorbidity factors, and they might need [a] sooner fourth dose to protect them," CEO Stephane Bancel told CNBC.

Moderna wants to give FDA ‘flexibility' in deciding eligibility for 4th Covid shot, CEO says

Shares of Moderna Inc. MRNA, -4.28% gained 0.4% in premarket trading on Thursday after the company said it's now signed $21 billion in advance purchase agreements for 2022 for its COVID-19 vaccine. That's up from $19 billion in signed agreements at the end of February.

Moderna now has $21 billion in signed deals for its COVID-19 vaccine in 2022

Moderna Inc on Thursday raised its full-year forecast for sales of its COVID-19 vaccine to roughly $21 billion from $19 billion.

Moderna raises full-year COVID vaccine sales forecast to $21 billion

COVID-19 vaccine Phase 2/3 study in children 6 months to under 6 years has successfully met its primary endpoint with robust neutralizing antibody titers similar to adults. Moderna is moving forward with global regulatory submissions for mRNA-1273 for primary vaccination of children 6 months to under 6 years of age.

Moderna Announces Clinical and Program Updates at 3rd Annual Vaccines Day

BioNTech SE

Novavax

Ocugen, Inc.

Pfizer

The picture is improving for vaccine stocks. But there's still a lot of uncertainty.

Is It Time to Buy COVID-19 Vaccine Stocks Again?

On-shore manufacturing facility based in Melbourne, Australia, expected to produce up to 100 million mRNA respiratory vaccine doses annually CAMBRIDGE, MA / ACCESSWIRE / March 23, 2022 / Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced the finalization of a strategic partnership with the Australian Federal Government to establish a state-of-the-art, domestic mRNA vaccine manufacturing facility in Australia. This finalizes the agreement in principle with the Australian Federal Government announced in December 2021.

Moderna Finalizes Strategic Partnership with Australian Government

Children received 25% of the dose adults got in tests.

Moderna Seeks FDA Authorization For COVID-19 Vaccine For Kids Under 6

Moderna Inc  (NASDAQ:MRNA) stock is down 4.2% at at $178.82 this morning, after the company released efficacy data for its two-dose Covid-19 vaccine for children under 6 years of age.

Moderna Stock Falls Despite Efficacy Update

Moderna announced Wednesday its COVID-19 vaccine works in children from 6 months old to under 6 years old.

Moderna says COVID-19 vaccine works for children under 6 years old

Moderna announced it would seek approval from the US Food and Drug Administration, the European Medicines Agency, and other global regulators.

Moderna says its coronavirus shot works in young kids and will ask regulators to OK its use

Interim data from a late-stage study showed that the vaccine induced a strong neutralizing antibody response in children aged 6 months to under 6 years.

Moderna Will Ask the FDA to Authorize Its Covid Vaccine for Young Kids

Moderna Inc. MRNA, +6.47% said Wednesday that it will seek authorization from the Food and Drug Administration to use its COVID-19 vaccine in children younger than 6 years old based on new clinical data. The company said its shot had a 43.7% efficacy rate in children between the ages of 6 months and 2 years old and a 37.5% efficacy rate in children between the ages of 2 and 6 years old.

Moderna's COVID-19 shot has about 40% efficacy in young children and infants

Moderna Announces Positive Data on Vaccine in Young Children, Will Ask FDA for Authorization

If approved, it will be the first Covid-19 vaccine available to children under the age of five in the U.S.

Moderna Will Seek Emergency Use Approval For Low-Dose Covid Vaccine In Kids Under 6

Moderna also asked the FDA to authorize its vaccine for children 6- to 11-years-old, the company announced on Wednesday.

Moderna Covid vaccine for kids under 6-years-old was up to 44% effective against omicron infection

Two 25 μg doses of mRNA-1273 in participants 6 months to under 6 years met primary endpoint with robust neutralizing antibody titers similar to adults mRNA-1273 was generally well tolerated in this age group Although not a primary endpoint, statistically significant vaccine efficacy was observed during the Omicron wave that was consistent with the lower two-dose effectiveness against Omicron seen in adults Moderna is moving forward with global regulatory submissions for mRNA-1273 for primary vaccination of children 6 months to under 6 years of age Additionally, Moderna has initiated a submission to the FDA for emergency use authorization of mRNA-1273 in children 6 to under 12 years of age; mRNA-1273 is approved for use in this age group in Europe, Canada and Australia CAMBRIDGE, MA / ACCESSWIRE / March 23, 2022 / Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced positive interim data from the Phase 2/3 KidCOVE study of the Moderna COVID-19 vaccine (mRNA-1273) in children 6 months to under 2 years and 2 years to under 6 years of age. This interim analysis showed a robust neutralizing antibody response in both age groups after a 25 µg two-dose primary series of mRNA-1273 along with a favorable safety profile.

Moderna Announces its COVID-19 Vaccine Phase 2/3 Study in Children 6 Months to Under 6 Years Has Successfully Met Its Primary Endpoint

Moderna Inc is sponsoring sumo flags in its first such promotion in Japan, as the U.S. firm seeks to build on its new-found renown in COVID-19 vaccines and wrestle market share from compatriot Pfizer Inc.

COVID vaccine maker Moderna flags Japan ambition with sumo sponsorship

Etsy

U.S. indices finished higher Tuesday amid strength in Nike Inc (NYSE: NKE) following third-quarter earnings. Investors also weighed Monday comments from Fed chair Powell suggesting the Fed would take necessary steps to curb inflation.

Etsy, Moderna Lead The S&P 500 Higher

Moderna Inc (NASDAQ: MRNA) shares are trading higher Tuesday after the company announced two new vaccine candidate developments.  Moderna will launch a respiratory combination vaccine program to target three of the most significant viruses causing respiratory disease in older adults.

Why Moderna Shares Are Trading Higher Today

Moderna said Tuesday that it would expand its COVID-19 vaccine to treat related illnesses.

Moderna expands COVID-19 vaccines to treat related illnesses

The FDA advisory committee meeting on Apr 6 is likely to give an insight into how the regulatory agency feels about the need for additional boosters of COVID-19 vaccines.

FDA Panel to Discuss Fourth Booster Dose in April Meeting

Study will focus on group childcare and early childhood education settings located in Worcester and Cambridge to understand transmission and support prevention of CMV WORCESTER, Mass. , March 22, 2022 /PRNewswire/ -- UMass Chan Medical School today announced a research collaboration with Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA)-based therapeutics and vaccines, on a comprehensive study of cytomegalovirus (CMV) transmission in group childcare, education, and household settings.

UMass Chan Medical School announces research collaboration with Moderna to examine impact of Cytomegalovirus (CMV) in young children

mRNA-1230 is a combination respiratory vaccine candidate against SARS-CoV-2 virus, influenza virus and respiratory syncytial virus (RSV) mRNA-1287 is a vaccine candidate against the four endemic human coronaviruses (HCoV-229E, -NL63, -OC43 and -HKU1) CAMBRIDGE, MA / ACCESSWIRE / March 22, 2022 / Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that it is expanding its mRNA pipeline with two new development programs. This announcement reflects the Company's commitment to expanding its portfolio by building on Moderna's experience with Spikevax®, its COVID-19 vaccine.

News for Moderna Stock (MRNA)