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]

Vaccine maker Novavax (NASDAQ:NVAX) saw its shares jump 18% on June 5 and another 20% in pre-market trade this morning. NVAX stock is up over 300% year-to-date. NVAX stock is due to open today at $24.10 per share, a market capitalization of about $3.6 billion on 2023 revenue of $656 million. But Novavax lost the race to deliver its vaccines to Pfizer (NYSE:PFE) and Moderna (NASDAQ:MRNA). Shares fell to below $10 in 2023. Talk show host Peter Sagal recently missed a show because of Covid. Singer Linda Ronsta ...

Novavax (NASDAQ:NVAX) is on a recovery trek after collapsing in late 2021. Recently, management said that its latest vaccine version addressing newer Covid-19 subvariants is more effective than older injections. According to a Reuters report, vaccine makers presented animal study data which "showed their 2024-25 shots targeting the JN.1 variant that was dominant earlier this year could neutralize newer subvariants such as KP.2 much better than the older shots." Novavax and other vaccine developers, includin ...

In this meeting, members of the VRBPAC will discuss whether to update the currently authorized COVID-19 vaccines to target the JN.1 variant. This was also recommended by a World Health Organization (WHO) advisory committee on Apr 26. Shares of COVID-19 vaccine developers rose on Monday after the FDA issued briefing documents for its Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting on Jun 5 to consider the selection of the 2024-2025 formula for COVID-19 vaccines. The FDA pointed o ...

GAITHERSBURG, Md., May 30, 2024 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced it will participate in the 2024 Jefferies Global Healthcare Conference. Conference Details: Contacts: Investors Erika Schultz 240-268-2022 [email protected] Media Giovanna Chandler 240-720-7804 [email protected] About Novavax | Fireside Chat | | | --- | --- | | Date: | Thursday, June 6, 2024 | | Time: | 12:30 – 12:55 p.m. Eastern Time (E ...

Novavax (NVAX) has been one of the most searched-for stocks on Zacks.com lately. So, you might want to look at some of the facts that could shape the stock's performance in the near term. Shares of this vaccine maker have returned +261.3% over the past month versus the Zacks S&P 500 composite's +4.2% change. The Zacks Medical - Biomedical and Genetics industry, to which Novavax belongs, has gained 6.2% over this period. Now the key question is: Where could the stock be headed in the near term? Although medi ...

Novavax (NASDAQ:NVAX) stock was among the laggards in the race for the vaccine against COVID-19. Unsurprisingly, NVAX stock plunged from highs of $320 in 2021 to recent lows of $3.5. However, with the company announcing a deal with Sanofi (NASDAQ:SNY), the stock skyrocketed by 280% last month. With the likelihood of the return of the meme stock frenzy, it's a good time to look at biotech stocks to buy for returns that can replicate the performance of NVAX stock. Therefore, I am looking at speculative ideas ...