Moderna (MRNA) Stock News

Moderna (NASDAQ:MRNA) has received FDA approval for mNEXSPIKE (mRNA-1283), its third approved product and new COVID-19 vaccine for adults 65+ and high-risk individuals aged 12-64. The approval is based on a Phase 3 trial with 11,400 participants, where mNEXSPIKE demonstrated 9.3% higher relative vaccine efficacy compared to Moderna's original Spikevax vaccine, with a 13.5% improvement in those 65 and older. The vaccine showed a similar safety profile to Spikevax with fewer local reactions. Common side effects include injection site pain, fatigue, headache, and myalgia. Moderna plans to make mNEXSPIKE available for the 2025-2026 respiratory virus season alongside Spikevax and mRESVIA.

Moderna (NASDAQ:MRNA) announced positive interim results from a Phase 1/2 clinical study of its investigational pandemic influenza vaccine, mRNA-1018, targeting H5 avian influenza. The study involving 300 healthy adults showed that 97.8% of participants achieved protective antibody levels with a 44.5-fold increase in titers from baseline. The vaccine demonstrated a rapid, potent, and durable immune response with good tolerability. However, Moderna also revealed that the U.S. Department of Health and Human Services (HHS) will terminate funding for the late-stage development and purchase rights of pre-pandemic influenza vaccines. Despite this setback, CEO Stéphane Bancel emphasized the positive clinical data and announced plans to explore alternative paths for the program's development.

Moderna (NASDAQ: MRNA) has announced its upcoming participation in two major investor conferences in June 2025. The company will present at the Jefferies Global Health Care Conference on June 5th at 10:30am ET and the Goldman Sachs 46th Annual Global Healthcare Conference on June 11th at 8:40am ET.

Live webcasts of both presentations will be accessible through the "Events and Presentations" section on Moderna's investor website. Replays will remain available for at least 30 days after each presentation.

Moderna (NASDAQ:MRNA) has submitted an FDA application for its updated Spikevax 2025-2026 formula, specifically designed to target the SARS-CoV-2 LP.8.1 variant. The submission aligns with FDA guidance recommending COVID-19 vaccines be updated to a monovalent JN.1 lineage, with preference for the LP.8.1 variant.

Moderna (NASDAQ:MRNA) has voluntarily withdrawn its Biologics License Application (BLA) for mRNA-1083, its combination flu/COVID vaccine candidate for adults aged 50 and older. The withdrawal comes after consultation with the FDA. The company plans to resubmit the BLA later in 2025 after obtaining vaccine efficacy data from the ongoing Phase 3 trial of mRNA-1010, its investigational seasonal influenza vaccine. Interim data from the mRNA-1010 trial is expected to be available in summer 2025.

Cellarity has appointed Ted Myles as its new Chief Executive Officer and CEO-Partner at Flagship Pioneering. Myles brings extensive biopharma leadership experience, previously serving as CFO and COO of Scholar Rock where he raised over $1 billion and led the company through a successful Phase 3 study. His prior roles include executive positions at AMAG Pharmaceuticals, Ocata Therapeutics, and PrimeraDx.

The appointment comes as Cellarity prepares for its first clinical study in 2025. The company leverages an AI/ML-enabled platform for drug discovery, focusing on understanding dysregulated pathways in diseased human cells. Their lead program, CLY-124, is a potential first-in-class small molecule for sickle cell disease treatment, targeting fetal hemoglobin induction through a novel mechanism, with clinical development expected to begin in mid-2025.

Moderna (NASDAQ: MRNA) has announced its upcoming participation in Bernstein's 41st Annual Strategic Decisions Conference (SDC). The presentation is scheduled for Thursday, May 29th, 2025, at 10:00 AM ET. Investors and interested parties can access a live webcast of the presentation through the "Events and Presentations" section on Moderna's investor website at investors.modernatx.com. The webcast recording will remain available on the company's website for a minimum of 30 days after the presentation.

Moderna (NASDAQ:MRNA) reported Q1 2025 financial results with revenues of $0.1 billion, showing a GAAP net loss of $(1.0) billion and EPS of $(2.52). The company reiterated its 2025 revenue guidance of $1.5-2.5 billion and announced cost reduction plans targeting $1.4-1.7 billion in operating cost savings by 2027. Q1 sales included $84 million from Spikevax and $2 million from mRESVIA. R&D expenses decreased 19% to $856 million, while SG&A expenses fell 23% to $212 million. Cash position stood at $8.4 billion. The company is advancing multiple late-stage pipeline candidates, including next-generation COVID-19 vaccine, RSV vaccine, and various oncology therapeutics, with up to 10 products progressing toward approval.

Flagship Pioneering and Quotient Therapeutics have appointed Rahul Kakkar, M.D. as CEO-Partner and Chief Executive Officer. Dr. Kakkar brings nearly 20 years of experience in biotech entrepreneurship and medicine, previously serving as CEO of Tome Biosciences and Pandion Therapeutics, which was acquired by Merck for $1.85 billion.

Jake Rubens, Quotient's co-founder and former CEO, will transition to a board director role after successfully establishing the company's first industrial platform for discovering drug targets through somatic genomics and securing a collaboration with Pfizer in cardiovascular and renal diseases.

Dr. Kakkar, who continues to practice at Brigham and Women's Hospital and lecture at Harvard Medical School, will lead Quotient's efforts in advancing its pipeline and platform technology. The company's focus on somatic genomics aims to discover novel drug targets and create first-in-class medicines for various diseases.