In a Jan. 10 research note, analyst Michael Higgins with Ladenburg Thalmann reported that Novavax Inc. (NVAX:NASDAQ) just released updated Phase 2 data that show NanoFlu's "superiority to the market leader" Fluzone HD in several H3N2 strains that cause the most deaths.
In the trial, Novavax's eggless flu vaccine was assessed against two comparators, including Fluzone HD, in adults aged 65 and older. Newly released results were from day 28 of the study.
Higgins highlighted the significant advantages of NanoFlu. One, a finding that was revealed in the newly released data, is its efficacy against "drifted strains" that can be deadly, as well as against homologous strains.
"Efficacy against drifted strains is likely the most difficult to get and is the best indication of how a vaccine will handle the annual variability that stumps so many flu vaccines," Higgins added. "The mismatching between the recommended strains and the actual flu strains produces the sharp year-to-year differences in flu deaths."
Another benefit of NanoFlu is it eliminates the potential for "virus egg adaptations" through its egg-free manufacturing of the product, the analyst stated.
Higgins concluded that "based on Phase 2 results, we believe that NanoFlu could become the new standard of care for older adults."
Next for NanoFlu are further data releases from the Phase 2 study. Also, Novavax will meet with the FDA, likely in April, to discuss the Phase 2 study results, a Phase 3 trial design and the potential for faster approval of the vaccine. An accelerated pathway would mean the Phase 3 study could launch in Q4/19 and end in early Q1/20. "We believe such a path is possible," indicated Higgins.
Ladenburg Thalmann has a Buy rating and a $3.50 per share price target on Novavax, whose stock is currently trading at around $2.17 per share.
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Disclosures from Ladenburg Thalmann, Novavax, Inc., January 10, 2019
ANALYST CERTIFICATION: I, Michael Higgins, attest that the views expressed in this research report accurately reflect my personal views about the subject security and issuer. Furthermore, no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report, provided, however, that:
The research analyst primarily responsible for the preparation of this research report has or will receive compensation based upon various factors, including the volume of trading at the firm in the subject security, as well as the firm’s total revenues, a portion of which is generated by investment banking activities.
COMPANY SPECIFIC DISCLOSURESLadenburg Thalmann & Co. Inc. makes a market in Novavax, Inc.
Ladenburg Thalmann & Co. Inc. has managed or co-managed a public offering for Novavax, Inc. within the past 12 months.
Ladenburg Thalmann & Co. Inc. intends to seek compensation for investment banking and/or advisory services from Novavax, Inc. within the next 3 months.
Ladenburg Thalmann & Co. Inc received compensation for investment banking services from Novavax, Inc. within the past 12 months.
Ladenburg Thalmann & Co. Inc had an investment banking relationship with Novavax, Inc. within the last 12 months.