Welcome to our dedicated page for Moderna news (Ticker: MRNA), a resource for investors and traders seeking the latest updates and insights on Moderna stock.
Moderna, Inc. reports developments in mRNA medicines, including commercial vaccines, investigational respiratory vaccines, oncology programs and rare-disease candidates. News commonly covers regulatory authorizations and agency interactions for products such as Spikevax, mRESVIA, mNEXSPIKE and mCOMBRIAX, as well as clinical data for seasonal influenza, pandemic influenza and cancer immunotherapy programs including intismeran autogene and mRNA-4359.
Company updates also include quarterly financial results, revenue mix, expense actions, strategic partnerships, scientific meeting presentations and intellectual-property matters tied to Moderna's infectious disease portfolio and broader mRNA technology platform.
Flagship Pioneering has announced a new collaboration between its drug discovery unit Pioneering Medicines and Pfizer to discover potential novel inhibitors for autoimmune disease treatment. The partnership will utilize Logica, a platform developed by Valo Health and Charles River that combines AI-powered technology with drug discovery expertise to translate biological insights into optimized small molecules.
This marks the sixth agreement under the strategic partnership between Flagship Pioneering and Pfizer, following previous collaborations with ProFound Therapeutics, Quotient Therapeutics, Montai Therapeutics, and Ampersand Biomedicines. The initiative aims to address the unmet needs in autoimmune disease management by developing more effective, safer, and personalized treatment options.
Moderna (NASDAQ:MRNA) has received approval from the Australian Therapeutic Goods Administration (TGA) for mRESVIA®, its mRNA vaccine against respiratory syncytial virus (RSV), for adults aged 60 and older. The vaccine is designed to prevent lower respiratory tract disease caused by RSV infection.
This marks a significant milestone as the first mRNA vaccine approved in Australia for use beyond COVID-19. The approval is supported by data from the Phase 3 ConquerRSV trial, which involved approximately 37,000 adults aged 60+ across 22 countries.
The approval addresses a significant health concern, as RSV laboratory-notified cases in adults aged 65+ during the 2024 Australian winter period reached nearly two-thirds of influenza cases. Notably, 90% of RSV-related deaths were reported in those aged 60 years and older. The vaccine will be supplied from Moderna's Melbourne facility.
Lila Sciences, founded by Flagship Pioneering in 2023, has emerged with a groundbreaking scientific superintelligence platform and autonomous labs for life, chemical, and materials sciences. The company has secured $200 million in seed financing from multiple investors including Flagship Pioneering, General Catalyst, and ARK Venture Fund.
The platform combines generative AI with autonomous AI science units to scale and optimize experimentation across scientific domains. Early achievements include developing advanced LLMs, generating optimal genetic medicine constructs, discovering novel antibodies, and creating cost-effective green hydrogen catalysts.
Led by CEO Geoffrey von Maltzahn and a team of experts including Chief Scientist George Church and CTO Andrew Beam, Lila's platform will be available to partners in life and material sciences industries to accelerate solutions in human health and sustainability.
Moderna (NASDAQ:MRNA) has received marketing authorization from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) for mRESVIA, its RSV vaccine for adults 60 years and older. This marks Moderna's second approved product in the UK.
The vaccine, designed to prevent lower respiratory tract disease caused by respiratory syncytial virus (RSV), will be manufactured at the Moderna Innovation and Technology Centre in Oxfordshire. RSV significantly impacts UK elderly adults, causing 175,000 GP appointments, 14,000 hospitalizations, and 8,000 deaths annually in those 65 and older.
The approval is based on the Phase 3 ConquerRSV trial, which involved approximately 37,000 adults aged 60+ across 22 countries. No serious safety concerns were identified during the trial.
Moderna (Nasdaq: MRNA) has announced its upcoming participation in two major investor conferences in March 2025. The company will present at the TD Cowen 45th Annual Health Care Conference on Wednesday, March 5th at 9:10am ET, and at the Barclays 27th Annual Global Healthcare Conference on Tuesday, March 11th at 1:30pm ET.
Investors and interested parties can access live webcasts of both presentations through the "Events and Presentations" section of Moderna's investor website at investors.modernatx.com. For those unable to attend the live events, replays of the webcasts will remain available on the company's website for at least 30 days following each presentation.
YourBio Health and Flagship Pioneering have announced the appointment of Paul Owen as CEO of YourBio Health and CEO-Partner of Flagship Pioneering. Owen brings over 35 years of corporate leadership experience, most recently serving as Board Director and President of Oncodea.
YourBio Health's key product, the Touch-Activated Phlebotomy (TAP®) device, is the first push-button blood collection technology using microneedles for virtually painless blood draws. The technology has been implemented in clinical trials, diagnostic settings, and wellness applications, with millions of blood collections completed since its commercial launch.
The company has established partnerships with biopharmaceutical companies, genetic companies, and academic research hospitals. The announcement also includes concurrent appointments to YourBio's leadership team, adding expertise in medical device product innovation, clinical strategy, and commercialization.
Moderna (MRNA) reported Q4 2024 revenues of $1.0 billion with a GAAP net loss of $(1.1) billion and EPS of $(2.91). Full-year 2024 revenues were $3.2 billion with a net loss of $(3.6) billion and EPS of $(9.28). The company's Q4 Spikevax sales reached $923 million, while mRESVIA sales were $15 million.
For 2025, Moderna expects revenues between $1.5-2.5 billion and projects year-end cash balance of approximately $6 billion. The company has submitted three mRNA products for regulatory approval: next-generation COVID vaccine, RSV vaccine for adults 18-59, and a flu/COVID combination vaccine.
Cost reduction efforts resulted in a 27% decrease compared to 2023, with plans to remove nearly $1 billion in costs by end of 2025. The company maintains a strong cash position of $9.5 billion as of December 31, 2024, though down from $13.3 billion year-over-year.
Moderna (NASDAQ:MRNA) has announced it will host a live conference call and webcast on Friday, February 14, 2025, at 8:00 a.m. ET to present its fourth quarter and full year 2024 financial results, along with a corporate update. The webcast will be available in the "Events and Presentations" section of Moderna's investor website. Following the conference call, an archived version of the webcast will be accessible on the company's website for one year.
Moderna (NASDAQ:MRNA) has secured a tender for supplying its mRNA COVID-19 vaccine in the European Union, Norway, and North Macedonia. The agreement allows 17 participating countries to access Moderna's vaccine for up to four years.
The company will provide various vaccine formats, including pre-filled syringes, which are preferred by healthcare providers as they can reduce administration errors and save time, potentially improving vaccination campaign efficiency.
This announcement follows the European Commission's marketing authorization granted in September 2024 for Moderna's updated COVID-19 mRNA vaccine Spikevax, which targets the SARS-CoV-2 variant JN.1. The vaccine is authorized for individuals six months of age and older.
Moderna (NASDAQ:MRNA) has received ongoing support from the U.S. Department of Health and Human Services (HHS) to accelerate the development of mRNA-based pandemic influenza vaccines. The $590 million award, made through the Rapid Response Partnership Vehicle (RRPV) Consortium with BARDA funding, will support late-stage development, licensure of pre-pandemic vaccines, and expansion of clinical studies for up to five additional pandemic influenza subtypes.
The company initiated a Phase 1/2 study in 2023 to evaluate safety and immunogenicity of mRNA-1018, an investigational pandemic influenza vaccine targeting H5 and H7 avian influenza viruses, in adults aged 18 and older. Following positive preliminary data, Moderna plans to advance mRNA-1018 to Phase 3 trials and will present Phase 1/2 results at an upcoming scientific meeting.