will cut five clinical programmes amid plans to reduce $1.1bn of R&D costs following years of declining revenues.
The company highlighted its rejig in priorities at its annual R&D day, saying that it will expand its commercial portfolio into oncology, rare diseases, and first-in-class non-respiratory vaccines, a strategy it hopes will generate ten product approvals over the next three years. The product launches include vaccines for Covid-19, flu, cytomegalovirus, norovirus, melanoma, and others.
Investor response was tepid, however, with the mRNA specialist鈥檚 stock opening 19% lower than yesterday (11 September). 聽It has since recovered slightly.
This announcement is the latest in a series of measures by Moderna to find its feet after its dwindling success from the Covid-19 pandemic. The company reported a net loss of $4.7bn for FY 2023, blaming a decline in sales of its Covid-19 vaccine, Spikevax. The company is advancing programmes in non-respiratory conditions in addition to its Covid-19 and flu vaccines, despite stating plans to move away from Covid-19.
While the company is advancing these programmes, it has slashed five others. It has discontinued preclinical mRNA-1287, a vaccine candidate against the four endemic human coronaviruses. Four Phase I candidates will also be dropped: mRNA-0184 for congestive heart failure, mRNA-5671, a KRAS-targeting cancer vaccine, cancer drug mRNA-2752, and its respiratory syncytial virus (RSV) vaccine mRESVIA (mRNA-1345) in infants.
In June, Moderna鈥檚 mRESVIA secured US Food and Drug Administration (FDA) approval for adults over the age of 60. This marked the first approval of an mRNA vaccine for a disease other than Covid-19, and Moderna鈥檚 second product to be approved.
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By GlobalDataIn the 12 September update, the company announced positive Phase III results for mRESVIA in 18鈥�59-year-olds, sharing that the vaccine met all primary immunogenicity endpoints. Moderna said it now plans to submit a supplemental biologic licence application (sBLA) for US approval later this year.
Moderna also said it plans to break even on an operating cash cost basis in 2028, two years later than the previously announced goal of 2026.
In the announcement accompanying the progress and strategic priorities, Moderna鈥檚 CEO St茅phane Bancel said: “Moderna now has five respiratory vaccines with positive Phase III results and expects to submit three for approval this year. In addition, we have five non-respiratory products in pivotal studies across cancer, rare diseases, and latent vaccines with potential for approval by 2027.
鈥淭he size of our late-stage pipeline combined with the challenge of launching products means we must now focus on delivering these ten products to patients, slow down the pace of new R&D investment, and build our commercial business.鈥�
