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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, 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, inhaled pulmonary 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.

Moderna finally earned approval for a non-coronavirus vaccine. The company's cancer vaccine candidate looks very promising.

3 Reasons to Buy Moderna Stock

Manufacturing is underway and doses of Moderna's Spikevax 2024-2025 formula will be ready to ship as early as August, pending regulatory approval CAMBRIDGE, MA / ACCESSWIRE / June 7, 2024 / Moderna, Inc. (NASDAQ:MRNA) today announced that it has submitted an application to the U.S. Food and Drug Administration (FDA) for review of its Spikevax 2024-2025 formula, targeting the SARS-CoV-2 variant JN.1. "For four years, Moderna has consistently delivered vaccines that offer protection against COVID-19, and work is well underway to provide a vaccine targeting JN.1," said Stéphane Bancel, CEO of Moderna.

Moderna Files FDA Application for the JN.1 Targeting COVID-19 Vaccine

The stock price of Moderna has seen a sharp 27% rise in a month, while its peer – BioNTech – has seen its stock rise 10% over this period. Moderna has a couple of factors to back its strong run.

Should You Pick Moderna Stock At $150 After 25% Gains In A Month?

Moderna stock is on the rise amid a bevy of news, including FDA approval for its RSV vaccine. Is MRNA stock a buy right now?

Is Moderna Stock A Buy After Its Second-Ever Product Snags FDA Approval?

Moderna, Inc. (NASDAQ:MRNA ) Jefferies 2024 Global Healthcare Conference June 6, 2024 10:00 AM ET Company Participants Jamey Mock - CFO Conference Call Participants Michael Yee - Jefferies Michael Yee [Starts Abruptly] of Moderna, Jamey Mock, up here with us. Jamey, it's great to be here.

Moderna, Inc. (MRNA) Jefferies 2024 Global Healthcare Conference (Transcript)

Broadcom

Hewlett Packard

Lam Research

Micron Technology

The S&P 500 touches a record high for the 25th time this year, powered by technology stocks. We have highlighted five technology stocks, HPE, MRNA, AVGO, MU and LRCX, leading the way higher in the latest trading session.

5 Stocks Propelling S&P 500 to 25th Record High

Center for Biologics Evaluation and Research has chosen mRNA-3705 as one of four investigational medicines for accelerated development to address unmet medical needs for rare diseases CAMBRIDGE, MA / ACCESSWIRE / June 6, 2024 / Moderna, Inc. (NASDAQ:MRNA) today announced that the U.S. Food and Drug Administration (FDA) has selected mRNA-3705 for the Support for Clinical Trials Advancing Rare Disease Therapeutics (START) pilot program. mRNA-3705 is an investigational therapeutic for methylmalonic acidemia (MMA) due to methylmalonic-CoA mutase (MUT) deficiency.

Moderna's Investigational Therapeutic for Methylmalonic Acidemia (mRNA-3705) Selected by U.S. Food & Drug Administration for START Pilot Program

Novavax

Pfizer

WASHINGTON — Government advisers Wednesday said it's time to update the recipe for the COVID-19 vaccines Americans will receive in the fall — targeting a version of the ever-evolving coronavirus called JN.1.

FDA advisers urge targeting JN.1 strain in fall's COVID vaccines

AbbVie

Novo Nordisk

The biotech sector has been through a lot in the past five years and it is finally rebounding. One of the most important sectors globally, it is hard to imagine life without biotech companies that provide life-changing drugs.

Biotech Blockbusters: 3 Pharma Stocks to Buy in June for Breakthrough Potential

Moderna, Inc. (NASDAQ:MRNA ) Moderna Oncology Investor Event June 3, 2024 7:15 PM ET Company Participants Stephen Hoge - President Kyle Holen - Head of Development, Therapeutics and Oncology Michelle Brown - Vice President, INT Oncology Rose Loughlin - VP, R&D Strategy Lavina Talukdar - SVP & Head of IR Conference Call Participants Luca Issi - RBC Capital Markets Gena Wang - Barclays Dina Elmonshed - Jefferies Terence Flynn - Morgan Stanley Jess Fye - JPMorgan Myles Minter - William Blair Mani Foroohar - Leerink Partners Stephen Hoge We're going to get started. Thank you, everybody, for taking some time out of ASCO and your time here to spend with us.

Moderna, Inc. (MRNA) Moderna Oncology Investor Event (Transcript)

Merck

Cancer vaccines are finally showing promise as Moderna and Merck touted promising data on an experimental skin cancer vaccine and the U.K. announced plans for a “landmark” scheme to test the technology across the country this week, after decades of research that could bring a new era of personalized medicine.

What To Know About Personalized mRNA Cancer Vaccines After Promising Trials From Moderna And Merck

Data from a key cancer conference has underlined the potential of a vaccine for melanoma that has now moved into late-stage clinical trials here in the UK.  Last month, we heard of the first dosing of Moderna Inc (NASDAQ:MRNA, ETR:0QF)'s potential breakthrough jab for a phase III study that could offer hope for sufferers of skin cancer when used in combination with Merck's Keytruda, a checkpoint inhibitor therapy.

Moderna cancer vaccine's potential revealed in phase II data

The RSV vaccine is Moderna???s (MRNA) second FDA-approved product.

Moderna (MRNA) Secures FDA Nod for mRNA-Based RSV Vaccine

Moderna and Merck said their experimental vaccine in combination with the therapy Keytruda improved survival and showed durable efficacy in a midstage study in patients with a deadly form of skin cancer. Nearly 75% of patients who took the combination were alive without any signs or symptoms of their cancer returning at the 2½-year mark.

Moderna, Merck say vaccine improved survival in patients with deadly skin cancer

Moderna and partner Merck & Co said on Monday their cancer vaccine in combination with blockbuster cancer therapy Keytruda improved survival and showed durable efficacy in a mid-stage study in patients with a deadly form of skin cancer.

Moderna-Merck skin cancer vaccine shows survival benefit in long-term follow-up

At a median planned follow-up of the Phase 2b study at 34.9 months, mRNA-4157 (V940) in combination with KEYTRUDA reduced the risk of recurrence or death by 49% and the risk of distant metastasis or death by 62% compared to KEYTRUDA alone in these patients The 2.5-year recurrence-free survival rate of mRNA-4157 (V940) in combination with KEYTRUDA was 74.8% as compared to 55.6% for KEYTRUDA alone, with the benefit observed across exploratory subgroups The companies have initiated Phase 3 studies in patients with high-risk melanoma and non-small cell lung cancer, in addition to Phase 2 studies in patients with renal cell carcinoma and urothelial carcinoma and a Phase 2/3 study for cutaneous squamous cell carcinoma CAMBRIDGE, MA and RAHWAY, NJ / ACCESSWIRE / June 3, 2024 / Moderna, Inc. (NASDAQ:MRNA) and Merck (NYSE:MRK), known as MSD outside of the United States and Canada, today announced the first presentation of results from a planned analysis from the Phase 2b randomized KEYNOTE-942/mRNA-4157-P201 study, a clinical trial evaluating mRNA-4157 (V940), an investigational individualized neoantigen therapy (INT), in combination with KEYTRUDA, Merck's anti-PD-1 therapy, in patients with resected high-risk melanoma (stage III/IV) following complete resection (n=157). With a median follow-up of approximately three years (34.9 months), adjuvant treatment with mRNA-4157 (V940) in combination with KEYTRUDA continued to demonstrate a clinically meaningful and durable improvement in recurrence-free survival (RFS), the primary endpoint of the study, reducing the risk of recurrence or death by 49% (HR [95% CI], 0.510 [0.288-0.906]; two-sided nominal p-value 0.019) compared with KEYTRUDA alone.

Moderna & Merck Announce 3-Year Data For mRNA-4157 (V940) in Combination With KEYTRUDA(R) (pembrolizumab) Demonstrated Sustained Improvement in Recurrence-Free Survival & Distant Metastasis-Free Survival Versus KEYTRUDA in Patients With High-Risk Stage II

Moderna earned approval for mResvia, a respiratory syncytial virus vaccine, on May 31. Instead of soaring in response to the great news, Moderna stock fell.

Is Moderna Stock a Buy Now That It's a 2-Product Company?

Moderna announced on Friday that the U.S. Food and Drug Administration (FDA) has approved its respiratory syncytial virus (RSV) vaccine for adults ages 60 and older. This will be the only RSV vaccine available in single-dose prefilled syringes and will be sold under the brand name mRESVIA.

Moderna secures a second FDA vaccine approval as Spikevax sales plummet

Moderna has brought in billions of dollars in earnings thanks to its coronavirus vaccine. But demand for that product has declined, and that has worried investors.

Moderna Investors Just Got Some Bullish News

Moderna, Inc. (NASDAQ:MRNA ) Bernstein's 40th Annual Strategic Decisions Conference May 31, 2024 10:00 PM ET Company Participants Stephane Bancel - CEO Conference Call Participants Courtney Breen - Bernstein Courtney Breen Hi, there, everyone. It's great to see you all on Friday of the conference.

Moderna, Inc. (MRNA) Bernstein's 40th Annual Strategic Decisions Conference (Transcript)

Moderna Inc.'s respiratory syncytial virus vaccine for older adults received U.S. regulatory approval, the company said Friday, marking the first time a messenger RNA vaccine has been approved for a disease other than COVID-19.

Moderna wins second product approval with RSV vaccine

The FDA approved Moderna's RSV vaccine, allowing the biotech to launch its second-ever product. But Moderna stock retreated.

Moderna Wins FDA Approval For Second-Ever Product; Why Its RSV Vaccine Could Dominate Pfizer, GSK

The Food and Drug Administration approved Moderna's vaccine for respiratory syncytial virus. The decision is a win for Moderna, which desperately needs another revenue source amid plunging demand for its Covid jab, its only commercially available product.

FDA approves Moderna's RSV vaccine for seniors, the company's second-ever product

The U.S. Food and Drug Administration has approved Moderna's respiratory syncytial virus (RSV) vaccine, the company announced on Friday, giving it a shot at much-needed new revenue from a second product.

US FDA approves Moderna's RSV vaccine, its second marketed product

mRESVIA is Moderna's second approved product and the only RSV vaccine available in single-dose pre-filled syringes CAMBRIDGE, MA / ACCESSWIRE / May 31, 2024 / Moderna, Inc. (NASDAQ:MRNA) today announced that the U.S. Food and Drug Administration (FDA) has approved mRESVIA (mRNA-1345), an mRNA respiratory syncytial virus (RSV) vaccine, to protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection. The approval was granted under a breakthrough therapy designation and marks the second approved mRNA product from Moderna.

News for Moderna Stock (MRNA)