Moderna

Moderna's mResvia RSV vaccine uptake slower than expected, facing challenges from GSK and Pfizer. Moderna executives acknowledge initial optimism and difficulties in contracting and CDC approval.

Moderna revised its break-even forecast from 2026 to 2028, leading to significant R&D cuts and a downgrade in stock ratings by firms like Jefferies and J.P. Morgan. The company plans to focus on 10 pipeline candidates, halting development of five programs, and expects a compounded annual growth rate of over 25% from 2026 to 2028.

Gene therapy tools enabling in vivo CAR T generation offer potential to make CAR T therapies faster, better, and cheaper, bypassing ex vivo limitations. Companies like Interius and Umoja are pioneering this approach with engineered lentiviral vectors and lipid nanoparticles, targeting immune cells directly in the body. This shift could blur the lines between cell and gene therapies, with initial trials in cancer and autoimmune diseases expected to yield significant insights by 2026.

Interim Phase I data of mRNA-4359 immunotherapy shows promise in advanced solid cancers, with 8/16 patients showing no tumor growth. The therapy activates immune response and is well-tolerated, supporting further research.

COVID-19 accelerated mRNA vaccine development, leading to record profits and FDA approval of mRNA vaccines. Moderna and Pfizer/BioNTech are expanding their mRNA pipelines into other diseases, with Moderna's RSV vaccine recently approved. The mRNA therapeutics market is projected to reach $68 billion by 2030. mRNA technology is favored for its rapid development potential compared to traditional vaccines. Five mRNA vaccine candidates, including Pfizer/BioNTech's influenza vaccine and Moderna's combination COVID-19/influenza vaccine, are highlighted as near-future prospects.

Surgeon General Joseph Ladapo advises against mRNA COVID-19 vaccines, questioning their efficacy against current strains. Despite this, many residents in The Villages are receiving the latest vaccine and flu shots. Ladapo's guidance on COVID-19 boosters for the 2024-2025 season highlights concerns over lack of human trial data and protection against dominant strains.

A new mRNA cancer vaccine, developed by Moderna, shows promise in halting tumor growth in advanced melanoma and lung cancer patients. Early trial results indicate no tumor growth in 8 out of 16 evaluated patients, with no serious side effects. The treatment aims to stimulate the immune system to recognize and fight cancer cells.

Moderna's stock drops due to delayed product launches, lowered revenue guidance, and extended break-even timeline, prompting analyst downgrades and investor skepticism.

Moderna acknowledges slower-than-expected uptake of its RSV vaccine, mResvia, amid competition from GSK and Pfizer. The company adjusts its market expectations and financial guidance, cutting R&D spending and discontinuing several pipeline projects. Moderna plans to focus more on oncology and respiratory disease vaccines, aiming to launch five new products by 2027.

Moderna plans to slow R&D spending, aiming for break-even by 2028 with $6 billion revenue, but analysts doubt it can avoid raising equity. Shares dropped 12% following the announcement, reflecting investor skepticism. The company aims for 10 product approvals by 2027, focusing on respiratory vaccines and diversifying its pipeline. Moderna's R&D spend will reduce from $4.6 billion to $3.8 billion annually by 2026-2028, with cuts impacting various programs, including respiratory, oncology, and cardiovascular.