At its annual R&D Day,
Moderna ( MRNA Quick Quote MRNA - Free Report) announced several updates about the advancements in its pipeline and its business outlook for 2028. Pipeline Updates Influenza Vaccine
Management provided an encouraging update on its reformulated seasonal influenza vaccine candidate, mRNA-1010. Interim analysis of data from the ongoing phase III immunogenicity study (P303) showed that mRNA-1010 elicited higher immune responses across all four A and B strains of influenza than
GSK’s ( GSK Quick Quote GSK - Free Report) Fluarix. The GSK vaccine is approved for use by the FDA in individuals aged six months and older.
In a separate phase I/II head-to-head study, mRNA-1010 elicited a higher antibody response across all four A and B strains over
Sanofi’s ( SNY Quick Quote SNY - Free Report) Fluzone HD, approved for use in older adults aged 65 years and above.
Moderna’s stock rose 3.2% on Sep 13, likely due to the encouraging response of its vaccine against the GSK and Sanofi vaccines, which dominate this target market space. In first-half 2023, the company reported setbacks in two separate late-stage studies on an earlier formulation of mRNA-1010, forcing management to update the vaccine formulation to improve immunogenicity against the influenza B strain. Data from the P303 study is expected to support Moderna’s filing for mRNA-1010, with a potential approval expected next year in April.
In the year so far, shares of Moderna have declined 39.5% compared with the
industry’s 13.1% fall. Image Source: Zacks Investment Research RSV Vaccine
Moderna’s FDA filing, seeking approval for using its RSV vaccine mRNA-1345 in older adults (60 years and older), is currently under review. The company is also working on expanding the use of mRNA-1345 in pediatric populations in a phase I study.
Recently, Moderna and its partner
Merck ( MRK Quick Quote MRK - Free Report) initiated a pivotal phase III study on its investigational individualized neoantigen therapy (“INT”) mRNA-4157 in melanoma patients. Moderna/Merck also announced plans to start another late-stage study on the INT candidate in non-small cell lung cancer (“NSCLC”) indication before this year-end. Others
Management announced that it has completed enrolling participants in a late-stage study on mRNA-1283, a next-generation refrigerator-stable COVID-19 vaccine. The company also completed enrolment in the pivotal phase III study on the CMV vaccine candidate, mRNA-1647.
The company also plans to start clinical studies on an mRNA-based therapy targeting phenylketonuria (“PKU”).
Moderna expects to launch 15 new products, including four products in rare diseases, over the next five years. The company expects an additional $10 billion to $15 billion in annual sales of cancer, rare and latent disease therapies by 2028. Management also
reiterated its previously announced revenue guidance of $8-$15 billion in product sales from its respiratory franchise by 2027.
Management plans to spend around $25 billion in R&D over the next five years.
The company also plans to resize its manufacturing footprint and supply base to increase its gross margin in the long term between 75% and 80%.
The advancements of its pipeline will enable Moderna to reduce its dependence on the COVID-19 vaccine, its sole marketed product, whose product sales have been declining significantly since last year. Based on the encouraging pipeline progress, Moderna expects to launch at least one new marketed product every year over the next three years. This includes its RSV, influenza and cancer vaccines. The company intends to advance up to 50 new pipeline candidates in clinical development by 2028.
Moderna currently carries a Zacks Rank #3 (Hold). You can see
. the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here