Moderna, Inc. - MRNA STOCK NEWS

Flagship Pioneering and Quotient Therapeutics have announced a collaboration with Pfizer to identify potential novel targets for cardiovascular and renal diseases. This agreement, initiated under the strategic partnership between Flagship Pioneering and Pfizer, leverages Quotient's Somatic Genomics platform to analyze somatic mutations in diseased patient tissue.

The collaboration involves two research programs aimed at discovering and developing transformative therapies. Pioneering Medicines, Flagship's in-house drug discovery unit, will lead the strategic partnership with Pfizer. This initiative represents a significant milestone in the partnership and highlights the potential of collaboration to accelerate therapeutic innovation in addressing cardiovascular and renal diseases, which are leading causes of mortality and morbidity worldwide.

Moderna (NASDAQ:MRNA) is facing a class action lawsuit for alleged violations of securities regulations. The Schall Law Firm has announced a reminder to investors who purchased Moderna securities between January 18, 2023, and June 25, 2024, to join the lawsuit before October 8, 2024.

The lawsuit claims Moderna made false and misleading statements about its mRESVIA (mRNA-1345) product, overstating its effectiveness and commercial prospects. When the truth was revealed, investors reportedly suffered damages.

Shareholders who experienced losses are encouraged to contact the Schall Law Firm to discuss their rights. The class has not yet been certified, and interested parties can choose to participate or remain absent class members.

Moderna's mRNA RSV vaccine, mRESVIA®, has received European Commission approval for adults aged 60 and older. This marks the first mRNA vaccine approved beyond COVID-19 in Europe. The approval is based on the Phase 3 ConquerRSV trial, which showed 83.7% vaccine efficacy against RSV lower respiratory tract disease. With 8.6 months median follow-up, efficacy remained at 63.3%. RSV causes about 160,000 hospital admissions annually in the EU, with 92% in adults 65+. mRESVIA is uniquely offered in a pre-filled syringe for easier administration. The vaccine was previously approved by the FDA in May 2024.

Moderna (NASDAQ:MRNA) has received approval from Japan's Ministry of Health, Labour and Welfare for an updated COVID-19 mRNA vaccine targeting the SARS-CoV-2 variant JN.1. This aligns with recommendations from a Japanese health ministry panel and the WHO for the 2024/2025 national immunization program. The program will offer vaccination to individuals aged 65 and older, as well as qualifying individuals aged 60-64.

Japan, with about 30% of its population aged 65 and above, aims to reduce the disease burden and pressure on the health system. Moderna has also entered an agreement with Mitsubishi Tanabe Pharma for co-promotion of its mRNA respiratory vaccine portfolio in Japan.

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.