Moderna Inc (NASDAQ: MRNA) initiated a large-scale Phase 3 study of its coronavirus vaccine candidate in mid-July.
An analyst at Jefferies conducted a statistical analysis of the study design to arrive at the likely timing of the data readout — whether they think the study will achieve statistical significance.
The Moderna Analyst: Michael Yee has a Buy rating on Moderna with a $90 price target.
Benzinga is covering every angle of how the coronavirus affects the financial world. For daily updates, sign up for our coronavirus newsletter.
The Moderna Thesis: Fast enrollment and the above-average infection rate in hot spots will drive a 70% probability of Moderna having preliminary late-stage data by October/November, Yee said in a Monday note. (See his track record here.)
"Based on our statistical model, we could be in for a 'Halloween Treat' with data achieving statistical significance potentially as early as October," the analyst said.
The company's Phase 3 study has a 65% chance of working, with an October readout followed by Emergency Use Authorization by end of 2020, in his view.
These catalytic events could pave the way for the unlocking of multi-billion-dollar sales potential, Yee said.
The analyst said he sees risks such as slowing infection rates in hot spots, low efficacy and competition from others by early 2021.
In a fast enrollment/high incidence rate scenario, if the drug efficacy is 50%-60%-plus, the study would hit with a p-value less than 0.0001 by Oct. 29, he said.
With a more conservative enrollment or infection rate, statistical significance could be hit study goals by mid-November to December, Yee said.
Other variables that could push the timing are a more efficacious vaccine that could slow events; and the inability to meet the FDA guidance of statistical success that also includes the lower bound of the confidence interval of less than 30%, Yee said.
"Thus, there is a possibility the study achieves the 50-60% point estimate on efficacy but does not yet meet the "lower bound CI hurdle" which would necessitate the need for more patients and events to detect a difference."
MRNA Price Action: At last check, Moderna shares were trading 3.51% higher to $76.70.
The Week Ahead In Biotech: Novavax Coronavirus Vaccine Readout, FDA Decisions And More Earnings
Attention Biotech Investors: Mark Your Calendar For August PDUFA Dates
Latest Ratings for MRNA
Initiates Coverage On
View More Analyst Ratings for MRNA
View the Latest Analyst Ratings
See more from Benzinga
© 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.