Novavax NVAX stock price rose nearly 20% on Wednesday after the company announced that the FDA has placed its experimental combined COVID-19 and influenza vaccine (“CIC”) and standalone influenza vaccine candidate on clinical hold. It fell.
The clinical hold comes after “spontaneous reports” of motor neuron problems in study participants who received the CIC vaccine as part of a Phase II trial conducted outside the United States in January last year. . The study was completed in July 2023, but the adverse events were reported last month. Novavax was notified of the clinical hold placement last Friday.
Motor neuropathy is a condition that occurs when the nerves that control movement are damaged.
Impact of clinical hold on Novavax stock
This clinical hold is likely to delay Novavax’s original plan to begin Phase III immunogenicity studies of its CIC vaccine and single influenza vaccine by the end of this year.
Management does not believe its vaccine was the cause of the adverse event, but is working closely with the FDA to resolve the issue. We are also working quickly to begin late-stage research on vaccines.
Novavax confirmed that the clinical hold described above does not affect its current COVID-19 vaccine.
NVAX stock price performance
The clinical hold announcement was not well-received by investors, citing concerns about Novavax’s growth. The company currently has only one product on the market, a protein-based coronavirus vaccine, but its late entry into the U.S. market has slowed demand.
Some investors are also concerned that clinical trial holds could jeopardize Novavax’s recent multibillion-dollar deal with pharmaceutical giant Sanofi SNY for a protein-based COVID-19 vaccine. was.
Year-to-date, Novavax stock has surged 111.4% versus the industry’s decline of 1.8%.
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Sanofi deal breathes new life into NVAX stock
Starting next year, Sanofi will have the right to co-market Novavax’s coronavirus vaccine worldwide, except in certain countries where the company has existing partnership agreements. The French drugmaker also has the sole license to develop and market the Novavax vaccine in combination with its own influenza vaccine.
In return, Sanofi paid Novavax a $500 million upfront payment. It also plans to pay up to $700 million in milestone payments. Novavax will phase out sales of Sanofi’s COVID-19 vaccine, Sanofi’s combined influenza and COVID-19 vaccine, and other combination vaccines developed by Sanofi, including the Novavax COVID-19 vaccine. Eligible to receive royalty payments in the digits.
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The deal bodes well for Novavax, as it helped remove prior warnings about the company’s ability to continue operations and provided management with funding to support ongoing pipeline programs. Both NVAX and SNY will retain the rights to develop a combination coronavirus and influenza vaccine at their own expense.
Other players developing combined coronavirus and influenza vaccines
Apart from Novavax, major pharmaceutical companies such as Pfizer PFE and Moderna MRNA are also developing their respective combination coronavirus and influenza vaccines using mRNA technology. Both peers are much more advanced than NVAX as their candidates are in later stages of development.
Moderna currently leads all competitors in the COVID-19/influenza combination space. In June, MRNA reported positive late-stage trial results for mRNA-1083, an investigational mRNA-based combination vaccine against influenza and COVID-19, in older adults (50 years and older) . The study met its primary endpoint and showed that mRNA-1083 elicited higher immune responses against influenza and COVID-19 than the single licensed influenza and COVID-19 vaccines .
Based on these results, MRNA plans to submit a regulatory application for approval of mRNA-1083 by the end of this year, with the support of a priority review voucher to accelerate the FDA approval process. The aim is to have a commercially available vaccine by next year.
Pfizer suffered a major setback in this area a few months ago when it reported data from a Phase III study of its investigational mRNA-based combination coronavirus and influenza vaccine. This study failed to achieve one of its two primary objectives regarding immunogenicity. PFE is currently evaluating adjustments to combination vaccine programs to improve the immune response to influenza B and will discuss next steps with health authorities. Pfizer is developing this vaccine in collaboration with BioNTech.
Novavax Co., Ltd. Price
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NVAX’s Zacks Rank
Novavax currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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