Core Viewpoint - Novavax, Inc. has made significant progress in its R&D strategy and financial performance, including the removal of the clinical hold on its COVID-19-Influenza Combination vaccine and the authorization for its updated COVID-19 vaccine for the 2024-2025 season [1][5][7]. Financial Performance - Total revenue for Q3 2024 was $85 million, a decrease from $187 million in Q3 2023 [9]. - Product sales amounted to $38 million, primarily from the U.S. market, while licensing, royalties, and other revenue were $46 million [9]. - The net loss for Q3 2024 was $121 million, compared to a net loss of $131 million in the same period in 2023 [9][18]. Operational Highlights - The company ended Q3 2024 with $1 billion in cash and receivables [1]. - Novavax is advancing its partnership with Sanofi for the Nuvaxovid™ COVID-19 vaccine, with a milestone payment of $50 million expected upon completion of pediatric clinical trial database lock [4]. - The FDA has removed the clinical hold on Novavax's Investigational New Drug application for its COVID-19-Influenza Combination and stand-alone influenza vaccine candidates [5]. R&D Strategy - Novavax is focusing on expanding its early-stage pipeline beyond COVID-19 and influenza, utilizing its proven technology platform [2]. - The company has outlined guiding principles for its new R&D strategy and appointed Ruxandra Draghia-Akli as Executive Vice President and Head of R&D [5]. - Ongoing pre-clinical programs for pandemic influenza and respiratory syncytial virus (RSV) are being advanced towards IND readiness [5]. Cost Management - Novavax achieved a 26% reduction in combined R&D and SG&A expenses in Q3 2024 compared to the same period in 2023 [6]. - The company targets combined R&D and SG&A expenses of approximately $500 million for 2025 and $350 million for 2026, reflecting a significant reduction from previous years [6]. Market Position - The updated COVID-19 vaccine has received Emergency Use Authorization from the U.S. FDA for individuals aged 12 and older, with broader access through over 30,000 locations in the U.S. [7][9]. - Global authorizations have been received, including in the European Union, Canada, and Taiwan [9].

Core Insights - Novavax has received approval from the FDA to resume testing its combination COVID-19-flu and standalone flu vaccines, which had previously been put on hold due to a serious adverse event reported in a patient [1] - The FDA's clinical hold was lifted after Novavax provided sufficient information addressing the concerns raised, allowing the company to begin enrolling participants for the planned Phase 3 trial [1] - Following the announcement, Novavax's shares increased by 1%, and the stock has risen nearly 90% year-to-date [1] Company Summary - The FDA had previously halted Novavax's vaccine trials after a report of a serious adverse event (motor neuropathy) in a Phase 2 trial participant [1] - Novavax's Chief Medical Officer stated that the data provided to the FDA indicated that the adverse event was unrelated to the vaccine, supporting the company's position [1] - The company is now preparing to initiate its Phase 3 trial as soon as possible [1]

Novavax (NVAX) is scheduled to report third-quarter 2024 earnings on Nov. 12, before the opening bell. In the last reported quarter, the company’s earnings missed estimates by 45.60%.The Zacks Consensus Estimate for sales is pegged at $57.3 million while that for earnings is pinned at a loss of 87 cents per share.Stay up-to-date with all quarterly releases: See Zacks Earnings Calendar.Factors Shaping NVAX’s Upcoming ResultsAlthough Novavax secured the FDA’s authorization for an updated version of its protei ...

Core Points - Novavax, Inc. has received clearance from the U.S. FDA to proceed with its Phase 3 trial for the COVID-19-Influenza Combination (CIC) and stand-alone influenza vaccine candidates after addressing all clinical hold issues [1][2] - The clinical hold was initially imposed due to a serious adverse event reported during a Phase 2 trial, which was later determined to be unrelated to the vaccine [2] Company Overview - Novavax, Inc. is focused on developing innovative vaccines to combat serious infectious diseases, utilizing a recombinant protein approach and its patented Matrix-M adjuvant to enhance immune response [3] - The company's portfolio includes a COVID-19 vaccine and candidates for the CIC and stand-alone influenza vaccines, with its adjuvant also being used in other vaccine collaborations [3]

The market expects Novavax (NVAX) to deliver a year-over-year increase in earnings on lower revenues when it reports results for the quarter ended September 2024. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates.The earnings report, which is expected to be released on November 12, 2024, might help the stock move higher if these key numbers are ...

GAITHERSBURG, Md., Nov. 4, 2024 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced it will report its third quarter 2024 financial results and operational highlights at 8:30 a.m. Eastern Time (ET) on Tuesday, November 12, 2024. Details of the event and replay are as follows: Conference call details: Date: November 12, 2024 Time: 8:30 a.m. U.S. ET URL to register phone: https://emportal.ink/3Y6irHG Dia ...

Novavax (NVAX) closed the latest trading day at $10.07, indicating a -1.76% change from the previous session's end. The stock fell short of the S&P 500, which registered a gain of 0.16% for the day. At the same time, the Dow lost 0.37%, and the tech-heavy Nasdaq gained 0.78%. Shares of the vaccine maker have depreciated by 18.84% over the course of the past month, underperforming the Medical sector's loss of 4.09% and the S&P 500's gain of 1.67%. Investors will be eagerly watching for the performance of Nov ...

NEW YORK, Oct. 23, 2024 (GLOBE NEWSWIRE) -- Attorney Advertising -- Bronstein, Gewirtz & Grossman, LLC is investigating potential claims on behalf of purchasers of Novavax, Inc. (“Novavax” or “the Company”) (NASDAQ: NVAX). Investors who purchased Novavax securities are encouraged to obtain additional information and assist the investigation by visiting the firm’s site: bgandg.com/NVAX. Investigation Details On October 16, 2024, Novavax issued a press release “announc[ing] that the U.S. Food and Drug Adminis ...

Novavax (NVAX) is one of the stocks most watched by Zacks.com visitors lately. So, it might be a good idea to review some of the factors that might affect the near-term performance of the stock.Shares of this vaccine maker have returned -21.2% over the past month versus the Zacks S&P 500 composite's +4.5% change. The Zacks Medical - Biomedical and Genetics industry, to which Novavax belongs, has lost 1.5% over this period. Now the key question is: Where could the stock be headed in the near term?While media ...

Let's look beyond this piece of bad news from regulators.Vaccine maker Novavax (NVAX -1.64%) has had a rollercoaster of a year. In May, the company's shares soared after it announced a lucrative agreement with biotech giant Sanofi. It's been mostly downhill for Novavax since then, though that's likely due to some profit taking by investors.However, Novavax's shares recently dropped by about 20% in one day after it announced a clinical setback. The biotech's stock price is still up by more than 100% for the ...