Moderna

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.

Moderna delays break-even goal to 2028, predicting 2025 sales below current year forecast, due to extended regulatory timelines for flu and cancer vaccines. Shares drop 17.1% to $65.88. Expects $2.5B-$3.5B in 2025 sales, below analyst forecast of $3.74B. Plans to submit FDA applications for RSV and COVID-influenza combo shots.

Moderna's mRNA-4359 vaccine, targeting advanced melanoma and solid tumours, shows potential in early trials, with 8 out of 16 patients experiencing no tumour growth. The treatment, using mRNA tech similar to COVID-19 vaccines, primes the immune system to recognize and fight cancer cells, with no serious side effects reported. The results, to be presented at a European oncology conference, mark an important step towards a new cancer treatment.

Moderna’s mRNA cancer vaccine for solid tumours shows early immune response in Phase I/II trial, with 8/16 patients not seeing tumour growth. The vaccine targets PD-L1 and IDO1 proteins, aiming to activate immune cells against cancer. Moderna plans to present interim data at the European Society of Medical Oncology meeting on 14 September.

Moderna delays break-even goal to 2028, expects 2025 sales below 2024 forecast, and plans to cut $1.1 billion in R&D costs from 2026. The company cites challenges in launching new products and slower-than-expected RSV vaccine adoption.

FDA declined accelerated approval for Moderna and Merck’s mRNA-4157 melanoma vaccine, citing challenges in reviewing AI-developed drugs, despite ongoing discussions.

The American Health Care Association/National Center for Assisted Living launched the #GetVaccinated campaign to boost senior vaccination rates against respiratory viruses, despite vaccine fatigue and access barriers. The campaign includes best practices, factsheets, and resources on vaccine administration. LeadingAge partners with HHS’s ‘Risk Less. Do More.’ campaign to raise awareness. A survey found 37% of vaccinated individuals are hesitant to get shots this year, with payment issues complicating access in nursing homes. AHCA/NCAL and LeadingAge emphasize the importance of consistent vaccine recommendations to combat fatigue and mistrust.

GSK's phase 2 data for its seasonal influenza mRNA vaccine, GSK4382276A, showed robust immune responses against A and B strains in older and younger adults, supporting progression to phase 3 trials. The vaccine demonstrated acceptable safety and reactogenicity profiles, aiming to develop a best-in-class vaccine for greater protection during flu season.