Biotech & Genomic Medicine▼
Moderna Gets FDA Approvals for Updated COVID and First mRNA Flu Shots
Moderna received FDA approval for updated Spikevax and mNEXSPIKE COVID-19 vaccines tailored to the latest SARS-CoV-2 subvariant, as well as mFlusiva, its first mRNA-based influenza vaccine for adults aged 50 and over. These approvals expand Moderna's respiratory vaccine portfolio and mark the first FDA-authorized mRNA flu shot for older adults. The company, a US-based biotechnology firm developing messenger RNA medicines, sees these approvals as reinforcing its regulatory momentum and diversifying its respiratory offerings against competitors like Pfizer and Novavax in COVID and Sanofi and GSK in flu. However, analysts note that respiratory shots still depend on annual uptake, pricing, and pharmacy stocking, so the key question is how far these launches reduce reliance on a narrow set of seasonal products.
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Pfizer's Updated COVID Shot Wins FDA Approval
Pfizer won FDA approval Thursday for its updated Comirnaty COVID vaccine, with deliveries starting immediately and doses expected in pharmacies and clinics within days. The vaccine, developed with BioNTech, is now limited to adults 65 and older and higher-risk patients aged 5 to 64, a much smaller market than the pandemic-era rollout. Comirnaty has distributed over five billion doses worldwide, but the new seasonal demand is uncertain. Pfizer faces competition from Moderna and the Novavax-Sanofi protein vaccine. Shares traded at $27.9079 on August 28, 5.27% above the GF Value estimate of $26.51, indicating a premium before uptake and reimbursement details emerge.
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Novavax Partners Secure Nuvaxovid Approvals for 2026-2027 Season
Novavax's partners have received approvals for the XFG-adapted Nuvaxovid vaccine for the 2026-2027 vaccination season in the U.S., European Union, and Japan, positioning the company to earn royalties on net sales in these markets. The approvals, announced August 28, 2026, cover the protein-based, non-mRNA vaccine, which has demonstrated a favorable tolerability profile in Sanofi's Phase 4 COMPARE study. Novavax's largest partner, Sanofi, will lead commercial activities in most major markets, including an expanded U.S. campaign and launches in Germany, Canada, and other international markets from 2026 onward. Takeda, which commercializes Nuvaxovid in Japan, saw the vaccine become the second-most used COVID-19 vaccine there in the 2025-2026 season, with delivery volumes and site numbers increasing significantly year over year. Under the collaboration and license agreements, Novavax is eligible for ongoing royalties and annual milestones tied to regulatory approvals, without carrying its own commercial infrastructure.
Biotech & Genomic Medicine▲impact 4
Biotech stocks hit post-pandemic high after Moderna, Merck mRNA cancer trial win
Biotech stocks reached their highest level since the height of the pandemic after Moderna and Merck announced that a late-stage trial testing their messenger RNA-based cancer therapy met its main goals. Healthcare became the best-performing sector in the S&P 500, with the State Street SPDR S&P Biotech ETF adding more than 4% to reach its highest level since February 2021. The individualized neoantigen therapy intismeran autogene, combined with Merck's Keytruda, improved recurrence-free survival with a statistically significant and clinically meaningful effect in the Phase 3 INTerpath-001 trial. Moderna shares more than doubled, Merck added over 12%, and rival vaccine makers BioNTech and Novavax also gained sharply. Gene editing companies including Prime Medicine, Intellia, CRISPR, Editas Medicine, and Beam Therapeutics were notable gainers, while AI-related biotechs Absci and Recursion Pharmaceuticals rallied after Anthropic selected Twist Bioscience as an independent evaluator.
Novavax Beats Q2 Estimates and Expands Big-Pharma Partnerships
Novavax reported second-quarter 2026 revenue of US$56.7 million and a net loss of US$53.39 million, beating analyst expectations for both revenue and earnings despite sharp year-on-year declines. The company highlighted progress on partnerships with Sanofi and Pfizer, while also filing an US$82.47 million employee stock offering shelf registration. The results underscore Novavax's reliance on milestone and royalty income from its Matrix M adjuvant and partnered vaccine portfolio as standalone sales remain weak.
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Novavax Stock Falls 1.6% as Market Rises, Earnings Decline Expected
Novavax shares closed at $7.37, down 1.6% in the latest trading session, underperforming the S&P 500's 0.21% gain. The vaccine maker's stock has fallen 19.98% over the past month, while the Medical sector lost 0.43% and the S&P 500 gained 1.7%. Analysts expect Novavax to report an EPS of negative $0.36 for the upcoming quarter, a 158.06% decline from the prior-year period, on projected revenue of $50.04 million, down 79.08%. For the full year, the Zacks Consensus Estimate anticipates an EPS of negative $0.19 and revenue of $371.85 million, representing declines of 107.36% and 66.9%, respectively. Despite these estimates, Novavax holds a Zacks Rank of 1, indicating a Strong Buy, and its industry, Medical - Biomedical and Genetics, ranks in the top 38% of over 250 industries.
Biotech & Genomic Medicine▲
Moderna Leads Therapeutics Stocks with 260% Revenue Surge in Q1
Moderna reported first-quarter revenues of $389 million, a 260% year-on-year increase that exceeded analyst expectations by 55.8%, making it the fastest-growing company among the 11 therapeutics stocks tracked. The group as a whole beat consensus revenue estimates by 14.5%, with shares up an average of 9.8% since reporting. Novavax posted revenues of $139.5 million, down 79.1% year-on-year but still beating estimates by 84.5%, the largest beat in the group. United Therapeutics was the weakest performer, with revenues of $781.5 million missing estimates by 1.9%, while Amgen reported $8.62 billion in revenue, up 5.8% and beating estimates by 1.4%.
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McKesson touted as top healthcare pick while AMN and Novavax flagged as sells
StockStory identified McKesson as a healthcare stock with impressive fundamentals, citing 14.3% annual revenue growth over two years, a dominant market position with $403.4 billion in revenue, and 17.9% annual EPS growth boosted by share buybacks. In contrast, it recommended selling AMN Healthcare Services due to declining travelers on assignment, falling EPS over five years, and diminishing returns on capital, and avoiding Novavax because of 22.6% annual sales declines over two years, a projected 50.7% sales drop, and cash-burning tendencies.
Therapeutics Stocks Q1 Earnings: Moderna Leads, United Therapeutics Lags
Among 11 therapeutics stocks tracked, first-quarter revenues beat analysts' consensus estimates by 14.5% on average. Moderna reported revenues of $389 million, up 260% year on year and exceeding expectations by 55.8%, making it the best performer in the group. United Therapeutics posted the weakest results with revenues of $781.5 million, down 1.6% year on year and missing estimates by 1.9%. Gilead Sciences reported revenues of $6.96 billion, up 4.4% year on year and beating expectations by 1.5%, but its full-year EPS guidance missed significantly. Novavax recorded the biggest analyst estimate beat with revenues of $139.5 million, down 79.1% year on year but surpassing expectations by 84.5%, while Myriad Genetics reported revenues of $200.4 million, up 2.3% year on year and missing estimates by 1%.