Source: IBD
Novavax (NVAX) reportedly plans to file for U.S. approval of its coronavirus vaccine candidate in December. NVAX stock wavered on the news.
Chief Executive Stanley Erck announced the company’s intentions in an interview with Czech daily Hospodarske Noviny published Thursday, according to Reuters. Novavax in May acquired a manufacturing facility in Bohumil, Czech Republic. There it plans to develop and manufacture some of its coronavirus vaccine candidate, NVX‑CoV2373.
NVAX stock seesawed between modest gains and losses on the stock market today. But shares tumbled late, ending the session down 6.3% at 107.35. A company spokesperson told IBD via email that a clarification of the CEO’s comments might be coming, but that had not happened as of 4:15 p.m. EDT.
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Categories: Vaccine
PRAGUE (Reuters) – Novavax Inc expects filing for approval of its COVID-19 vaccine candidate in the United States in December, Chief Executive Stanley Erck said in an interview for Czech daily Hospodarske Noviny, released on Thursday.
The company plans to produce part of the vaccine at its Czech plant, which will give the country access to the product once it is approved, the paper cited Erck as saying.
Novavax said on Monday it had begun enrolling volunteers for the second phase of an ongoing clinical trial of its COVID-19 vaccine candidate, with interim data expected in the fourth quarter of 2020.
https://finance.yahoo.com/news/novavax-despite-another-pullback-analyst-220929844.html
My, how times have changed. Since soaring on promising Phase 1 data for its COVID-19 vaccine, NVX-CoV2373, that reaffirmed the best-in-class immunogenicity and reactogenicity profile, the waters have been choppy for Novavax (NVAX), with shares currently sitting well below its 52-week high.
That said, 5-star analyst Mayank Mamtani, of B.Riley FBR, believes the recent weakness presents investors with a unique buying opportunity.
“We argue against the prevailing bearish sentiment on NVAX potentially falling behind in the second wave of COVID-19 vaccine candidates given the Phase 3 initiation timeline in early October, which might follow a surprise pre-Phase 3 Emergency Use Authorization (EUA) of the AstraZeneca’s vaccine candidate, AZD1222, and notably, around the timeline of Phase 3 efficacy readout from two mRNA candidates, Moderna’s mRNA-1273 and Pfizer/BioNTech’s BNT162b2,” Mamtani explained.
It should be noted that regardless of what the Phase 3 outcomes are for MRNA’s and PFE/BNTX’s vaccines, which are expected in September or October, Mamtani argues NVAX stands to benefit.
According to Mamtani, premature EUA authorization of AZD1222 before large randomized clinical efficacy trials are completed goes against the FDA’s statements that this path “could reduce the ability to demonstrate effectiveness of the investigational vaccine in a clinical disease endpoint efficacy trial to support licensure and such clinical disease endpoint efficacy trials may be needed to investigate the potential for vaccine-associated ERD.”
NVAX hasn’t jumped the gun when it comes to its Phase 3 study. Rather, the company conducted two Phase 2 studies to generate sufficient “manufacturing information and demonstrate the safety and effectiveness of ‘2373, which the agency may consider being more appropriate to receive EAU before the FDA has completed its formal review of the BLA,” in Mamtani’s opinion.
Looking more closely at NVAX’s Phase 2 program, which is being conducted across two different studies, the B.Riley FBR analyst likes its “breadth.” He added, “Based on the robust antibody responses, as well as the promising safety and tolerability profile generated in the Phase 1 portion of the Phase 1/2 study, two dose levels…will be evaluated. This, coupled with the previously announced Phase 2 2.9k-subject South Africa study and the 130-subject Phase 1 study, will generate a total of ~4.5K safety and efficacy dataset, well above the safety database of 3k study participants required by the FDA for pre-licensure.”
https://finance.yahoo.com/news/novavax-despite-another-pullback-analyst-220929844.html