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.
Moderna (Nasdaq: MRNA) has announced an upcoming Investor Event - R&D Day and Business Updates scheduled for September 12, 2024 at 9:00 a.m. ET. This event will feature presentations from the company's management team, focusing on Moderna's development and commercial strategy, as well as key business considerations.
Investors and interested parties can access a live webcast of the presentation through the 'Events and Presentations' section of Moderna's investor relations website. For those unable to attend the live event, a replay of the webcast will be available on the company's website for at least 30 days following the presentation, ensuring widespread access to this important corporate update.
Moderna (NASDAQ:MRNA) has received U.S. FDA approval for its updated COVID-19 vaccine, Spikevax (2024-2025 formula), targeting the KP.2 variant of SARS-CoV-2. The vaccine is approved for individuals 12 years and older, with Emergency Use Authorization (EUA) granted for those 6 months through 11 years. The updated vaccine is expected to be available in pharmacies and care settings across the U.S. in the coming days.
The FDA's decision is based on manufacturing and preclinical data, along with previous clinical, non-clinical, and real-world evidence. Moderna's CEO, Stéphane Bancel, emphasized that COVID-19 remains a significant health risk and the leading cause of respiratory illness-related hospitalization. The company is also manufacturing a JN.1 variant-targeted vaccine for other countries.
Moderna (NASDAQ:MRNA) and Coursera (NYSE:COUR) have partnered to launch a free online course called 'mRNAs as Medicines'. This three-module course, designed by Moderna experts, offers a comprehensive understanding of mRNA medicines, their functionality, and potential applications. The initiative aims to address the growing demand for STEM skills and close the workforce readiness gap.
The course covers topics such as protein and mRNA structure, their roles in the body, and how mRNA medicines can prevent and treat diseases. It's accessible to anyone registered as a Coursera learner, including students, scientists, and medical professionals. This collaboration aligns with both companies' commitments to advancing scientific education and fostering innovation, while addressing the projected need to fill 3.5 million STEM jobs in the U.S. by 2025.
Moderna (NASDAQ:MRNA) reported Q2 2024 financial results with revenues of $241 million, a GAAP net loss of $1.3 billion, and GAAP EPS of $(3.33). The company revised its 2024 product sales expectations to $3.0 to $3.5 billion. Key highlights include:
1. FDA approval for RSV vaccine mRESVIA, with U.S. shipments beginning in July
2. Positive Phase 3 data for combination influenza and COVID-19 vaccine
3. Positive Phase 3 data for next-generation COVID-19 vaccine
4. Cost of sales decreased by 84% compared to Q2 2023
5. R&D expenses increased by 6% to $1.2 billion
6. Cash position at $10.8 billion as of June 30, 2024
Moderna updated its 2024 financial framework, projecting lower EU sales and potential revenue deferrals for certain international sales into 2025.
Moderna (NASDAQ:MRNA) has announced that David M. Rubenstein, Co-Founder and Co-Chairman of The Carlyle Group, will join its Board of Directors on August 5, 2024. Rubenstein replaces retiring director Stephen Berenson and will serve on the Audit Committee. Co-founder Robert Langer is also retiring from the Board. Both Langer and Berenson will continue to provide advisory services to Moderna.
Rubenstein brings extensive experience in investing, business growth, and global policy. His appointment comes as Moderna enters its next stage of development as a global commercial company. The company's Nominating and Corporate Governance Committee plans to focus on recruiting directors with scientific and innovation experience to replace Dr. Langer.
Flagship Pioneering has unveiled Abiologics, a company developing a new class of supranatural and programmable medicines called Synteins™. These are computationally-generated and synthesized with novel building blocks, aiming to overcome limitations of traditional biologics. The Abiologics platform uses generative AI and high-throughput chemical protein synthesis to create Synteins with extraordinary properties.
Flagship has initially committed $50 million to advance the platform and develop a pipeline of medicines, focusing on oncology and immunology. Synteins can be programmed to interact with virtually any therapeutic target while evading the body's natural defenses, offering advantages such as less frequent dosing, oral delivery, and access to previously unreachable parts of the body.
Moderna (NASDAQ:MRNA) announced it will report its second quarter 2024 financial results on Thursday, August 1, 2024, at 8:00 a.m. ET. The company will host a live conference call and webcast to discuss the results and provide a corporate update. The webcast will be accessible via the Investors section of Moderna's website and an archived version will be available approximately two hours after the event, remaining online for one year.
Moderna is a leader in mRNA medicine, known for developing one of the earliest and most effective COVID-19 vaccines. The company focuses on creating therapeutics and vaccines for various conditions, including infectious diseases, immuno-oncology, rare diseases, and autoimmune diseases. For more information, visit modernatx.com.
Flagship Pioneering, a bioplatform innovation company, announced it has raised $3.6 billion to foster the growth of 25 groundbreaking companies in human health, sustainability, and AI. This includes $2.6 billion into Fund VIII and $1 billion from sector-specific partnerships, bringing the total capital raised since 2021 to $6.4 billion. The company now operates with an aggregate capital pool of $10.9 billion and manages $14 billion in assets.
Flagship's recent partnerships include collaborations with Pfizer, Samsung, Thermo Fisher Scientific, and Novo Nordisk. These alliances are part of Flagship's Innovation Supply Chain Partnership (ISC) model, which maximizes innovation across various stages of product development.
The company has expanded globally, establishing hubs in London and Singapore to enhance its R&D collaborations and access international talent. Flagship has also bolstered its leadership team with several key hires and promotions to drive its growth and innovation strategy.
Flagship Pioneering, a bioplatform innovation company, has expanded its leadership team with new appointments and promotions. These changes accompany an expanded capital base of $3.6 billion for the development of 25 breakthrough platform companies in human health, sustainability, and AI.
Key promotions include Lovisa Afzelius to General Partner, Paul Biondi to General Partner, Dina Ciarimboli as General Counsel, Marcello Damiani as Senior Partner, Gary Pisano as Chief Strategist, and other critical roles filled by experienced professionals. These leaders bring significant expertise from major firms like Pfizer, Bristol-Myers Squibb, Moderna, and Harvard Business School.
Flagship aims to leverage these appointments to drive innovation, enhance strategic partnerships, and improve operational efficiency across its ecosystem of companies, furthering its mission to pioneer transformative technologies.
Moderna and Mitsubishi Tanabe Pharma have signed a joint agreement to co-promote Moderna’s mRNA respiratory vaccine portfolio in Japan, including the COVID-19 vaccine, Spikevax®. Moderna will manage manufacturing, sales, medical education, and distribution, while both companies will work together to maximize public health impact in Japan. The agreement spans from now until March 31, 2029, with undisclosed financial terms. The partnership aims to leverage Mitsubishi Tanabe Pharma's extensive experience in the Japanese market.