Shares in Novavax are surging almost 8% in the pre-market session after the biotech company said additional data from the Phase 1/2 clinical trial of NVX‑CoV2373 showed more support that the Covid-19 vaccine candidate was well-tolerated and induced “robust” antibody responses.
The stock is rising to $111 in Thursday’s pre-market trading. Novavax (NVAX) said that the Phase 1 data published in The New England Journal of Medicine demonstrated that the vaccine has a reassuring safety and reactogenicity profile and induced robust antibody responses numerically superior to that seen in human convalescent sera.
“The rapid publication of Phase 1 results from our trial in a prestigious peer-reviewed journal reflects both the importance of the data and the urgent need for an effective vaccine to slow the COVID-19 pandemic,” said Novavax President of R&D Gregory M. Glenn. “Based on the positive Phase 1 results, we have begun multiple Phase 2 clinical trials, from which we expect to collect preliminary efficacy. Novavax is committed to generating the safety, immunogenicity and efficacy data that will support confident usage of the vaccine, both in the US and globally, and the data published today further bolsters our conviction that this is possible.”
The additional data showed that at day 35 of dosage, NVX-CoV2373 appeared to be safe, and it elicited immune responses that exceeded levels in Covid-19 convalescent serum. Overall reactogenicity was largely absent or mild.
The Phase 1 portion of the Phase 1/2 clinical trial was randomized, observer-blinded, and placebo-controlled.
NVX-CoV2373 is currently in multiple Phase 2 clinical trials. The Phase 2 portion of the Phase 1/2 clinical trial to evaluate the safety and immunogenicity of NVX-CoV2373 began in August in the US and Australia, and expands on the age range of the Phase 1 portion by including older adults 60-84 years of age, which make up about 50% of the trial group. Secondary objectives include preliminary evaluation of efficacy. In addition, a Phase 2b clinical trial to assess efficacy was started in South Africa in August.
Novavax’s vaccine candidate has been selected to be part of Operation Warp Speed (OWS), a US government program that seeks to begin supplying millions of doses of a safe, effective vaccine for COVID-19 in 2021. As part of the program, the company has been awarded with $1.6 billion in funding for testing and manufacturing as well as the supply of 100 million doses of the potential vaccine to the US as early as late 2020.
In the run-up to developing a coronavirus vaccine candidate, the stock has this year exploded 2,484%. However, NVAX has seen some sell-off activity recently, as the stock dropped 34% over the past month. (See Novavax stock analysis on TipRanks).
In a bullish note, B.Riley FBR analyst Mayank Mamtani last week reiterated a Buy rating on the stock with a $257 price target (150% upside potential) saying that investors should take additional advantage of the recent stock weakness.
“We argue against the prevailing bearish sentiment on NVAX potentially falling behind in the second wave of COVID-19 vaccine candidates given the Ph. III initiation timeline in early October,” Mamtani wrote in a note to investors. “With the large-scale manufacturing and global supply arrangements being put in place, we believe NVAX is well poised to catch up to its more advanced peers.”
The rest of the Street has a cautiously optimistic outlook on the stock. The Moderate Buy analyst consensus shows 4 Buy ratings versus 1 Sell rating. Meanwhile, the $227.60 average analyst price target indicates a promising 121% upside potential from current levels.
Medtronic’s First-Of-Its Kind Diabetes System For Young Children Approved
AstraZeneca Rises On Report Trump Could Fast-Track Covid-19 Vaccine Candidate
Abbott Expanding Its Covid-19 Test To Asymptomatic People- Report