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. (NASDAQ: MRNA) is a cutting-edge biotech company based in Cambridge, Massachusetts, founded in 2010. Moderna is at the forefront of pioneering messenger RNA therapeutics™, a revolutionary class of drugs that utilize mRNA technology to direct cells to produce proteins that can fight diseases. This innovative approach has shown promise in addressing targets that were previously considered untreatable with traditional drugs.
With over 200 patent applications and more than 10,000 claims, Moderna has a robust intellectual property portfolio that includes novel nucleotide chemistries and specific drug compositions. The company has successfully developed and commercialized several mRNA-based drugs, initially focusing on rare diseases and oncology, while partnering to advance drug candidates in other therapeutic areas.
Moderna’s mRNA technology gained global recognition with its COVID-19 vaccine, Spikevax®, which was one of the earliest vaccines to receive emergency use authorization in the United States in December 2020. As of mid-2023, Moderna had 39 mRNA development candidates in clinical trials, covering a wide range of therapeutic areas such as infectious diseases, oncology, cardiovascular diseases, and rare genetic disorders.
Some of Moderna's recent achievements include the advancement of three new vaccine programs—targeting Epstein-Barr virus, Varicella-Zoster virus, and norovirus—towards Phase 3 clinical trials. Additionally, the company initiated three new clinical studies combining its investigational individualized neoantigen therapy with Merck’s Keytruda® for treating various cancers.
Financially, Moderna reported first-quarter revenues of $167 million in 2024, with a GAAP net loss of $1.2 billion. Despite the decline in COVID-19 vaccine sales, the company reaffirms its 2024 expected product sales of approximately $4 billion. Moderna is preparing for the launches of its RSV vaccine and the Spikevax® 2024-2025 formula, demonstrating its commitment to fighting respiratory illnesses.
Moderna continues to focus on innovation and operational efficiency, utilizing AI technologies to enhance productivity. The company's long-term vision includes leveraging its mRNA platform to develop therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, and autoimmune diseases, striving to make a significant impact on global health.
Moderna, Inc. (Nasdaq:MRNA) will conduct a live conference call and webcast on May 4, 2023, at 8:00 a.m. ET to discuss its first quarter 2023 financial results and provide a corporate update.
The call will be accessible via the Moderna Investors website, with an archived version available two hours post-call for one year.
Founded over a decade ago, Moderna has evolved from a research-stage company into a leader in mRNA therapeutics and vaccines, successfully producing COVID-19 vaccines and developing a wide range of therapeutics. The company is recognized for its innovative mRNA technology and robust manufacturing capabilities, maintaining collaborative relationships to advance scientific and therapeutic breakthroughs.
Moderna (Nasdaq:MRNA) has entered into a partnership with IBM (NYSE:IBM) to leverage quantum computing and artificial intelligence for advancing mRNA medicine development. This collaboration includes investments in generative AI to enhance product design.
Moderna aims to build a workforce skilled in quantum technologies and will participate in IBM's Quantum Accelerator program. The goal is to apply quantum computing to complex scientific challenges, enhancing mRNA therapeutics.
Additionally, the companies will utilize the MoLFormer AI model to optimize lipid nanoparticles and mRNA, targeting improved safety and performance in new mRNA medicines. This investment underscores Moderna's commitment to pioneering technology in biotechnology.
Moderna and Merck announced positive results from the Phase 2b KEYNOTE-942 trial involving mRNA-4157 (V940) in combination with KEYTRUDA for treating high-risk stage III/IV melanoma. The combination therapy reduced the risk of recurrence or death by 44% compared to KEYTRUDA alone. The trial included 157 patients with a median follow-up of 23-24 months. In the combination group, 83.4% of patients were recurrence-free at 12 months, compared to 77.1% in the control group. The U.S. FDA granted Breakthrough Therapy Designation for this therapy. A Phase 3 study will start in 2023.
Moderna, Inc. (NASDAQ: MRNA) has made significant advancements in its clinical pipeline, including the dosing of the first participant in the Phase 3 trial for its next-generation COVID-19 vaccine, mRNA-1283. The company is also preparing to file for approval of another vaccine candidate, mRNA-1345, targeting RSV, within this quarter. However, the first influenza vaccine candidate, mRNA-1010, faced challenges as it did not achieve sufficient cases in an interim efficacy analysis, leading to continued follow-up recommendations from the independent DSMB. Positive preliminary results indicate strong immunogenicity against certain influenza strains. Moderna has introduced new vaccine candidates for Lyme disease and norovirus. The company established a financial framework projecting sales in its respiratory franchise to reach between $8 billion to $15 billion by 2027.
Moderna (NASDAQ:MRNA) and Merck (NYSE:MRK) announced that their investigational personalized mRNA cancer vaccine, mRNA-4157/V940, in combination with KEYTRUDA, has received PRIME scheme designation from the European Medicines Agency (EMA). This designation follows positive data from the Phase 2b KEYNOTE-942/mRNA-4157-P201 trial for treating high-risk stage III/IV melanoma after complete surgical resection. The first detailed results will be presented at the American Association for Cancer Research (AACR) from April 14-19. With a high unmet need for melanoma therapies, this designation aims to accelerate access to effective treatments for patients. Further, the FDA has granted Breakthrough Therapy Designation for the same combination, alongside plans for a Phase 3 study in 2023.
Moderna and the Government of Kenya have finalized an agreement to build an mRNA manufacturing facility in Kenya, marking the company's first such facility in Africa. The new facility aims to produce up to 500 million doses of vaccines annually, enhancing health security for Kenya and the broader African continent. This investment aligns with Moderna's global public health strategy to address unmet health needs, including infectious diseases like HIV and Ebola. The facility will operate under a Special Economic Zone status to facilitate economic growth and attract foreign investment.
Gandeeva Therapeutics has announced a research collaboration with Moderna Inc. (NASDAQ: MRNA) to explore applications of its cryogenic electron microscopy (cryo-EM) technology. The collaboration aims to validate Gandeeva's unique platform for a specific Moderna target, details of which remain undisclosed. The partnership reflects Gandeeva's drive to develop innovative therapeutics by integrating AI and structural biology to target challenging protein interactions. Research payments will be made by Moderna as part of the agreement, facilitating the advancement of Gandeeva's preclinical oncology pipeline.
Moderna, Inc. (NASDAQ:MRNA) will host its Vaccines Day for analysts and investors on April 11, 2023, at 8:00 a.m. ET. The event aims to showcase presentations on its mRNA vaccines and essential vaccine development insights from management and key opinion leaders. The presentation will be available via a live webcast and can be accessed later on Moderna's website. Over the past decade, Moderna has evolved from a research-stage entity to a leading biotechnology company, recognized for its groundbreaking mRNA therapeutics and vaccines, including significant contributions to COVID-19 vaccination efforts.