Latest news with #Spikevax
Reuters
04-06-2025
- Business
- Reuters
US appeals court sides with Moderna on COVID patent claims
June 4 (Reuters) - Moderna (MRNA.O), opens new tab convinced a U.S. appeals court on Wednesday to uphold a ruling that undercut patent infringement claims by biotech company Alnylam Pharmaceuticals (ALNY.O), opens new tab over Moderna's blockbuster COVID-19 vaccine Spikevax. The U.S. Court of Appeals for the Federal Circuit upheld, opens new tab a Delaware federal court's decision to interpret Alnylam's two patents in a manner that foreclosed its infringement arguments. Alnylam lost a similar dispute in a related Moderna case last year. It has filed separate, ongoing patent lawsuits over Pfizer's COVID shots. An Alnylam spokesperson said the company is reviewing the Wednesday ruling and considering its options. A Moderna spokesperson said it was pleased with the decision and that its vaccine was "a product of many years of pioneering mRNA platform research and development." Cambridge, Massachusetts-based Alnylam first sued Moderna and Pfizer for patent infringement in 2022 for allegedly using its lipid nanoparticle (LNP) technology in their vaccines to deliver genetic material into the body. The lawsuits are part of a web of patent disputes between biotech companies over COVID shots, which includes a lawsuit filed by Moderna against Pfizer later that year. Moderna and Alnylam jointly agreed to dismiss Alnylam's patent claims in the first case in 2023 after U.S. District Judge Colm Connolly interpreted the patents to cover a type of lipid that Spikevax did not have. A three-judge Federal Circuit panel upheld Connolly's interpretation on Wednesday. The case is Alnylam Pharmaceuticals Inc v. Moderna Inc, U.S. Court of Appeals for the Federal Circuit, No. 23-2357. For Alnylam: Paul Hughes of McDermott Will & Emery For Moderna: Jeffrey Lamken of MoloLamken Read more: Alnylam files patent infringement lawsuits against Pfizer, Moderna Alnylam to appeal ruling on patents related to Moderna's COVID vaccines Moderna fends off Alnylam US patent lawsuit over COVID shots, for now
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First Post
03-06-2025
- Health
- First Post
US okays Moderna's 'next generation' Covid-19 vaccine
The new vaccine, mNexspike (mRNA-1283), is a step toward next-generation coronavirus vaccines. It's made in a way that allows for a lower dose, a fifth of the dose of its current COVID-19 vaccine, Spikevax (mRNA-1273) by refining its immune target read more Moderna logo is seen displayed in this illustration taken, May 3, 2022. REUTERS Moderna, a vaccine manufacturer, said late last week that the FDA has authorised its next-generation COVID-19 vaccine. The new vaccine, mNexspike (mRNA-1283), is a step toward next-generation coronavirus vaccines. It's made in a way that allows for a lower dose, a fifth of the dose of its current COVID-19 vaccine, Spikevax (mRNA-1273) by refining its immune target. Moderna's approval was based on a phase 3 randomised controlled trial involving 11,400 participants ages 12 and older. The trial found that a 10-microgram (μg) dose of mNexspike demonstrated a 9.3% higher relative vaccine efficacy (rVE) compared to a 50-μg dose of Spikevax, with a 13.5% higher rVE in adults ages 65 and older. The two vaccinations have identical safety profiles, according to the manufacturer. STORY CONTINUES BELOW THIS AD The approval 'adds an important new tool to help protect people at high risk of severe disease from COVID-19,' Stephane Bancel, Moderna's CEO, said in a statement Saturday. The Food and Drug Administration approved the new vaccine for use in all adults 65 and older, and for people age 12 to 64 who have a least one health condition that puts them at increased risk from the coronavirus. That's the same limit that the FDA set in licensing another COVID-19 vaccine option from competitor Novavax. Those restrictions are a departure from how the US has handled COVID-19 vaccines until now, reflecting scepticism about vaccines from Health Secretary Robert F. Kennedy Jr. and other Trump officials. Moderna's existing vaccine doesn't face those limits and has long been used for anyone ages 6 months and older. The company said it expected to offer both options this fall. The news came just days after the Trump administration cancelled funding for Moderna to develop a vaccine against potential pandemic flu viruses, including the H5N1 bird flu, despite promising early study results. STORY CONTINUES BELOW THIS AD
Yahoo
02-06-2025
- Business
- Yahoo
Moderna Stock Climbs as FDA Approves New COVID-19 Vaccine
Moderna said the FDA approved its new COVID-19 vaccine "for use in all adults 65 and older, as well as individuals aged 12-64 years with at least one or more underlying risk factor." Shares of the pharmaceutical giant rose Monday morning but are still down by nearly 35% this year. Moderna's original COVID-19 vaccine generated $3.1 billion in sales last of Moderna (MRNA) climbed Monday after the Food and Drug Administration (FDA) approved the drugmaker's new COVID-19 vaccine. Moderna said its new vaccine, mNEXSPIKE, showed a higher relative efficacy in a clinical trial than its first FDA-approved COVID-19 vaccine and was approved "for use in all adults 65 and older, as well as individuals aged 12-64 years with at least one or more underlying risk factor as defined by the Centers for Disease Control and Prevention (CDC)." The Cambridge, Mass.-based company said it "expects to have mNEXSPIKE available for eligible populations in the U.S. for the 2025-2026 respiratory virus season, alongside Spikevax and mRESVIA, the Company's approved respiratory syncytial virus (RSV) vaccine." Moderna's original COVID-19 vaccine, Spikevax, generated $3.1 billion in sales last year. Moderna shares rose 2% soon after markets opened but have lost nearly 35% of their value in 2025. Read the original article on Investopedia Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
02-06-2025
- Business
- Yahoo
Moderna's New COVID Vaccine Secures FDA-Clearance For Seniors, At-Risk Individuals
The U.S. Food and Drug Administration (FDA) on Saturday approved Moderna, Inc.'s (NASDAQ:MRNA) mNexspike (mRNA-1283), a new vaccine against COVID-19, for all adults 65 and older and individuals aged 12-64 years with at least one or more underlying risk factor as defined by the Centers for Disease Control and Prevention (CDC). 'The FDA approval of our third product, mNEXSPIKE...,' said Stéphane Bancel, Chief Executive Officer of Moderna. The FDA's approval of mNEXSPIKE is based on results from a randomized, observer-blind, active-controlled Phase 3 trial, which enrolled approximately 11,400 participants aged 12 years and primary efficacy objective was to demonstrate the non-inferior vaccine efficacy against COVID-19 starting 14 days after mNexspike compared to that after the comparator vaccine, mRNA-1273 (Spikevax), Moderna's original COVID-19 vaccine. Participants received either a 10 μg dose of mRNA-1283 or a 50 μg dose of mRNA-1273. mRNA-1283 showed a 9.3% higher relative vaccine efficacy (rVE) compared to mRNA-1273 in individuals aged 12 years and older, and in a descriptive sub-group analysis, a 13.5% higher rVE in adults aged 65 and older. In the Phase 3 trial, mRNA-1283 was found to have a similar safety profile to mRNA-1273, with fewer local reactions and comparable systemic reactions. The most commonly solicited side effects were injection site pain, fatigue, headache and myalgia. Moderna expects to have mNexspike available for eligible populations in the U.S. for the 2025-2026 respiratory virus season, alongside Spikevax and mRESVIA, the company's approved respiratory syncytial virus (RSV) vaccine. William Blair writes, 'Approval of mRNA-1283 is an incremental win for Moderna, especially considering HHS Secretary Robert F. Kennedy Jr.'s negative public opinion on mRNA COVID-19 vaccines, and we continue to see autonomy and data-driven decisions at the FDA.' 'We do not see approval of mRNA-1283 as a massive boost to Moderna's COVID-19 vaccine sales, which we believe are primarily driven by sentiment surrounding the vaccination market in general, but this is a critical step in the regulatory path for the combo flu/COVID vaccine product, mRNA-1083, which uses mRNA-1283 as the COVID-19 component of its formulation,' analyst Myles Minter writes. Analyst Minter says Moderna is still facing challenges from new government policies, including losing about $700 million in funding from the Department of Health and Human Services for its bird flu vaccine project. In addition, William Blair writes that the company's goal to break even by 2028 is overly optimistic since it would need to more than double its revenue—based on cash costs—to reach that target. In May, the FDA approved Novavax, Inc.'s (NASDAQ:NVAX) Nuvaxovid for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adults 65 years and older and individuals 12 through 64 years who have at least one underlying condition that puts them at high risk for severe outcomes from COVID-19 (e.g. asthma, cancer, diabetes, obesity, smoking). Achievement of the U.S. license approval has triggered a $175 million milestone payment from Sanofi SA (NASDAQ:SNY). Price Action: MRNA stock is up 4.82% at $27.84 during the premarket session at the last check on Monday. Read Next:Photo by Wolfilser via Shutterstock Up Next: Transform your trading with Benzinga Edge's one-of-a-kind market trade ideas and tools. Click now to access unique insights that can set you ahead in today's competitive market. Get the latest stock analysis from Benzinga? MODERNA (MRNA): Free Stock Analysis Report This article Moderna's New COVID Vaccine Secures FDA-Clearance For Seniors, At-Risk Individuals originally appeared on © 2025 Benzinga does not provide investment advice. All rights reserved.
CNBC
02-06-2025
- Health
- CNBC
FDA approves Moderna's new lower-dose Covid-19 vaccine
The U.S. approved a new Covid-19 vaccine made by Moderna late Friday but with limits on who can use it — not a replacement for the company's existing shot, but a second option. The new vaccine, mNexspike, is a step toward next-generation coronavirus vaccines. It's made in a way that allows for a lower dose — a fifth of the dose of its current Covid-19 vaccine, Spikevax — by refining its immune target. The approval "adds an important new tool to help protect people at high risk of severe disease from Covid-19," Stephane Bancel, Moderna's CEO, said in a statement Saturday. The Food and Drug Administration approved the new vaccine for use in all adults 65 and older, and for people age 12 to 64 who have a least one health condition that puts them at increased risk from the coronavirus. That's the same limit that the FDA set in licensing another Covid-19 vaccine option from competitor Novavax. Those restrictions are a departure from how the U.S. has handled Covid-19 vaccines until now, reflecting skepticism about vaccines from Health Secretary Robert F. Kennedy Jr. and other Trump officials. Moderna's existing vaccine doesn't face those limits and has long been used for anyone ages 6 months and older. The company said it expected to offer both options this fall. The FDA's approval was based on a study of 11,400 people age 12 and older that compared the new low-dose vaccine with Moderna's existing vaccine. It found the new vaccine was safe and was at least as effective — and more by some measures — than the original shot, the company said. The news came just days after the Trump administration canceled funding for Moderna to develop a vaccine against potential pandemic flu viruses, including the H5N1 bird flu, despite promising early study results.
