Does it make sense to invest in COVID-19 vaccine stocks in 2024? It should make sense, at least in theory, since U.S. health regulators effectively gave Novavax (NASDAQ:NVAX) the green light to target a specific Covid-19 variant. Yet, it's too late to buy Novavax stock with confidence as meme-stock madness sent the share price to the moon already. I'll bet you never imagined that there would be a connection between GameStop (NYSE:GME) and Novavax. Yet, in these bizarre times, there's actually a link between ...

Novavax (NVAX) filed a regulatory application to the EMA, which seeks to update its protein-based COVID19 vaccine for the 2024/2025 vaccination campaign. This submission is in line with the EMA's guidance issued on Apr 30, which advised COVID-19 vaccine manufacturers like Moderna (MRNA) , Novavax, and Pfizer (PFE) to update their respective COVID-19 vaccines to target the JN.1 variant. Year to date, the stock has skyrocketed 192.1% against the industry's 4.1% fall. Image Source: Zacks Investment Research Un ...

Novavax (NVAX) has recently been on Zacks.com's list of the most searched stocks. Therefore, you might want to consider some of the key factors that could influence the stock's performance in the near future. Revisions to Earnings Estimates For the current quarter, Novavax is expected to post earnings of $1.13 per share, indicating a change of +94.8% from the year-ago quarter. The Zacks Consensus Estimate has changed +544.9% over the last 30 days. With an impressive externally audited track record, our prop ...

Novavax's JN.1 COVID-19 vaccine is active against current circulating strains, including KP.2 and KP.3 Novavax intends to have its vaccine in unit-dose vials available for distribution in the European Union for immediate release post-approval. Novavax has also filed with the U.S. Food and Drug Administration (FDA) and is working with other regulatory authorities globally on authorization or approval of its JN.1 COVID-19 vaccine. When added to vaccines, Novavax's patented saponin-based Matrix-M adjuvant enha ...

Heading into today, shares of the vaccine maker had lost 12.2% over the past month, lagging the Medical sector's gain of 0.03% and the S&P 500's gain of 3.59% in that time. Our research reveals that these estimate alterations are directly linked with the stock price performance in the near future. To benefit from this, we have developed the Zacks Rank, a proprietary model which takes these estimate changes into account and provides an actionable rating system. Novavax (NVAX) closed the most recent trading d ...

It was not long ago that Novavax (NASDAQ:NVAX) was among the stocks with high short interest. The stock had been trending lower for an extended period. However, with one positive news, NVAX stock skyrocketed from February lows of $3.5 to 52-week high of $23.86. This is just one example of short-squeeze stocks delivering multi-fold returns in quick time. In the meme euphoria of 2021, stocks with high short interest as a percentage of free-float was targeted by retail investors. With the meme stock frenzy on ...

Subject to necessary permissions from the FDA and CDC, Novavax intends to market this updated COVID-19 vaccine in pre-filled syringes by mid-August. If authorized/approved, it will be the only protein-based nonmRNA COVID-19 vaccine in the United States. The FDA's prior advice was in line with the recommendation issued by a World Health Organization (WHO) advisory committee on Apr 26. However, the FDA pointed out that post the WHO recommendation, another subvariant named KP.2 has become the dominant strain i ...

Novavax's updated JN.1 COVID-19 vaccine is active against current circulating strains, including KP.2 and KP.3 Novavax's JN.1 COVID-19 vaccine would be the only protein-based option available in the U.S. Novavax's filing is aligned with FDA, EMA and WHO global recommendations on vaccine composition Novavax intends to have its vaccine in pre-filled syringes available in the U.S. for immediate release postauthorization and following recommendation by the U.S. CDC Novavax's JN.1 vaccine has demonstrated broad ...

Shares of this vaccine maker have returned +104.6% over the past month versus the Zacks S&P 500 composite's +3.3% change. The Zacks Medical - Biomedical and Genetics industry, to which Novavax belongs, has gained 0.9% over this period. Now the key question is: Where could the stock be headed in the near term? Revisions to Earnings Estimates We essentially look at how sell-side analysts covering the stock are revising their earnings estimates to reflect the impact of the latest business trends. And if earnin ...

Regulatory and Supply Strategy - The FDA accepted the company's BLA filing and worked on a dual approach strategy, including an EUA pathway to expedite vaccine distribution for the JN 1 strain and prefilled syringe format, crucial for capturing 40-50% of the market opportunity in the first 3-4 weeks of the season [3] - The company anticipates ample supply for the US market, with JN 1 strain production on track and prefilled syringes expected to be ready by August, positioning the company for a stronger performance this season [31] - The company made a strategic decision with the FDA to pursue the EUA pathway alongside the BLA filing, with a PDUFA date set for April next year, aiming to align with the normal strain change submission cycle [59] Sanofi Partnership and Deal Structure - The Sanofi partnership was triggered by the company's three-pillar strategy, focusing on proving the technology, generating revenue, and reducing liabilities, which stabilized the company and enabled business development discussions [7] - The deal with Sanofi includes a $500 million upfront payment, a 5% equity investment, and $700 million in near and mid-term milestones, with additional potential value from ongoing royalties and milestones for new vaccines developed using the company's Matrix-M technology [8] - The partnership allows Sanofi to combine the company's COVID vaccine with their flu vaccines, creating combination products, with the company eligible for milestones and ongoing royalties for each new vaccine developed using Matrix-M [10][11] Market and Commercialization Strategy - The company is focusing on retail access for vaccine distribution, with 90% of COVID vaccine distribution going through retail channels, and is pleased with the traction on contracts and prefilled syringe adoption [5] - The company is preparing for the upcoming season with a strong position in the US and EU markets, leveraging the JN 1 strain and prefilled syringes, and expects to be ready for distribution by August [31] - The company remains an independent entity with its own pipeline, including two Phase 3 programs for a combination flu-COVID vaccine and a standalone flu vaccine, with data expected by next year [12] Financial and Operational Improvements - The company has significantly improved its financial health by reducing current liabilities by $1 5-2 billion and cutting OpEx by over $1 billion in the last 15 months, strengthening the balance sheet and enabling the Sanofi partnership [35] - The company plans to further reduce R&D and SG&A expenses to below $500 million next year, with a portion expected to be reimbursed, maintaining a lean and efficient operational structure [23] - The Sanofi deal provides the company with optionality and multiple layers of value, including milestones, royalties, and the ability to reduce costs and infrastructure, positioning the company for future growth and value creation [28][61] Pipeline and Future Opportunities - The company is advancing its late-stage pipeline, including a combination flu-COVID vaccine and a standalone flu vaccine, with Phase 3 data expected by next year and plans to expand its early-stage pipeline [12][41] - The company is exploring additional business development opportunities, including out-licensing its Matrix-M technology to other vaccine manufacturers, with the potential to lower COGS and improve immunogenicity [62] - The company is confident in its Phase 3 programs, with Phase 2 data supporting the approval pathway, and expects to file for both the combination flu-COVID vaccine and the standalone flu vaccine in the second half of next year [64]