DewDiligence
3 weeks ago
MRNA has a lot riding on ACIP’s recommendations for how often people should be boosted with RSV vaccines. ACIP meets in late June, and it will presumably make recommendations for mRNA-1345, assuming the FDA has approved it by then (PDUFA date 5/12/24).
If ACIP recommends biennial boosting with GSK’s and PFE’s RSV vaccines for the “at-risk” adult populations, but recommends annual boosting with MRNA’s mRNA-1345, that would be a pretty big blow to mRNA-1345’s commercial prospects. I’m not saying such an outcome is likely, but it is possible.
axelvento
3 weeks ago
In the fall vaccination season, Moderna captured 48% of the COVID-19 retail market in the United States versus a 37% showing in 2022, closing the gap on Pfizer’s Comirnaty
Much of the call was focused on Moderna’s respiratory syncytial virus (RSV) vaccine, which is lined up for an FDA decision in May. The company appears poised to join a market competition with GSK’s Arexvy and Pfizer’s Abrysvo, which achieved 2023 sales of $1.5 billion and $890 million, respectively, in their first year on the market for people ages 60 and older.
The company sees the RSV market booming to $10 billion, with sales of between $6 billion to $8 billion in the older adult population.
https://www.fiercepharma.com/pharma/while-moderna-moving-covid-its-vaccine-gaining-share-pfizers-comirnaty
axelvento
3 weeks ago
"it's written on the wall"The big news in Moderna's Q4 update was a surprise profit of $217 million, or $0.53 per share, based on generally accepted accounting principles (GAAP). The average analysts' estimate was for a Q4 loss of $0.90 per share.
Moderna also reported Q4 revenue of $2.8 billion, down from $5.1 billion in the prior-year period. However, this result was well above the consensus revenue estimate of $2.3 billion.
I don't think Moderna stock is a buy solely because of its Q4 results. My view is that risk-averse investors will be better off going with other stocks.
However, aggressive investors could find Moderna appealing right now. The company hopes to win U.S. regulatory approval for its respiratory syncytial virus (RSV) vaccine soon. It's also optimistic about filing for approval of seasonal flu vaccine mRNA-1010 this year. I predict Moderna's future will be brighter than its recent past.
https://www.fool.com/investing/2024/02/22/why-moderna-stock-is-jumping-today/
axelvento
1 month ago
In the absence of head-to-head clinical trials, comparative conclusions regarding the safety and efficacy of mRNA-1345 relative to other RSV vaccines cannot be made. These trials differed in study populations, geographic locations, infection surveillance methods, and case definitions used for RSV.
Moderna is anticipating approvals of mRNA-1345 in the first half of 2024. The Company is encouraged by the strong competitive profile for its RSV vaccine, with robust efficacy data meeting all pre-specified statistical criteria, a well-established safety and tolerability profile, and as the only pre-filled syringe product available at the time of launch.
https://investors.modernatx.com/Statements--Perspectives/Statements--Perspectives-Details/2024/Statement-on-RSVVW-Abstract-on-mRNA-1345-2024-Rk2gVDGnqc/default.aspx