Moderna

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.

Moderna to cut five clinical programs, aiming to reduce $1.1bn in R&D costs, focusing on expanding commercial portfolio into oncology, rare diseases, and non-respiratory vaccines. The strategy targets ten product approvals over three years, including vaccines for Covid-19, flu, and melanoma. Despite positive Phase III results for mRESVIA in 18–59-year-olds, investor response remains tepid, reflecting Moderna's challenges post-Covid-19 pandemic.

Moderna CEO Stephane Bancel told Nikkei the company could have a melanoma vaccine on the market as soon as next year, co-developed with Merck, targeting a 2027 launch but potentially accelerated.

Moderna forecasts $2.5-$3.5B in 2024 sales, with 25% annual revenue growth from 2026-2028 driven by new product launches. The company anticipates 10 new product approvals by 2027, with meaningful revenue from 2028. Moderna plans to expand RSV vaccine approval to high-risk adults under 60 and focus on a COVID-influenza combination shot.