Moderna‘s (NASDAQ:MRNA) stock witnessed a 3% surge on Wednesday following the company’s positive clinical updates during its Vaccines Day Event, showcasing progress in its pipeline.
Among the announcements, Moderna revealed its decision to propel three vaccines into pivotal late-stage development. These include mRNA-1189 (targeting Epstein-Barr virus [EBV]), mRNA-1468 (for Varicella-Zoster virus [VZV]), and mRNA-1405 (designed for norovirus).
This move was underpinned by promising data from early-stage clinical studies, indicating the vaccines’ immunogenicity and favorable tolerability among participants.
Additionally, Moderna is actively assessing various therapies in late-stage development, such as mRNA-1647 (for cytomegalovirus [CMV]), mRNA-4157 (individualized neoantigen therapy [INT]), and mRNA-1083 (a combined vaccine addressing COVID-19 and influenza).
While Moderna’s revenue stream heavily relies on its COVID-19 vaccine, which has witnessed a decline in sales globally, advancing three more vaccines to late-stage development signifies progress toward diversifying its product portfolio. Management anticipates a sizable total addressable market (TAM) of approximately $52 billion for its infectious disease vaccines.
In conjunction with the pipeline updates, Moderna disclosed a funding agreement with Blackstone Life Sciences. Under the terms, Blackstone will allocate up to $750 million to support Moderna’s influenza program, in exchange for potential milestone payments and low single-digit royalties.
Year-to-date, Moderna’s shares have surged by 11.2%, outpacing the industry’s growth of 0.6%.
Earlier this week, Moderna reported positive outcomes from a pivotal phase III study evaluating mRNA-1283, its next-generation refrigerator-stable COVID-19 vaccine, in individuals aged 12 years and older. The study met its primary endpoint, demonstrating a higher immune response among recipients of mRNA-1283 compared to Moderna’s previously approved bivalent Omicron BA.4/BA.5-targeting COVID vaccine.
These findings aim to bolster confidence in mRNA-1083, a combination formulation of mRNA-1283 and influenza vaccine mRNA-1010. Before the end of the year, Moderna plans to commence a regulatory submission to the FDA for mRNA-1010 as an independent influenza vaccine.
Additionally, Moderna anticipates FDA approval for its RSV vaccine mRNA-1345 for use in older adults aged 60 years and above, with a final decision expected before May 12. If approved, mRNA-1345 could mark Moderna’s second product launch, slated for commercial release in the third quarter of 2024. Plans are also underway to expand the usage of mRNA-1345 in pediatric populations.
Management is proceeding as planned to unveil data from late-stage studies assessing mRNA-1647 and mRNA-1083 later in the current year.
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