BioNTech SE (NASDAQ: BNTX) and Pfizer (NYSE: PFE) announced Thursday September 17, 2026 (syndicated Friday September 18) that Health Canada authorized their XFG-adapted Comirnaty (COVID-19 mRNA vaccine) for the 2026-2027 respiratory season in individuals aged 6 months and older. XFG (an LP.8.1 descendant Omicron subvariant lineage) was designated by WHO's Technical Advisory Group on COVID-19 Vaccine Composition (TAG-CO-VAC) in April 2026 as the preferred variant for 2026-2027 seasonal vaccine composition, and multiple regulators (FDA, EMA, MHRA) have already authorized XFG-adapted formulations. Distribution across Canadian provinces and territories is expected to commence within days to weeks pending CDA/CADTH reimbursement pathways. Health Canada's authorization follows the June 2026 approvals of the equivalent updated Moderna Spikevax and Novavax Nuvaxovid XFG-adapted formulations. Comirnaty remains BioNTech's flagship product; 2025 global revenue was approximately €4.2 billion.
Medicus Pharma (NASDAQ: MDCX) announced Wednesday September 2, 2026 a Co-Development and License Agreement with Pfizer (NYSE: PFE) granting Medicus an exclusive, sublicensable, royalty-bearing worldwide license to develop, manufacture, and commercialize PF-08046031 (CD228V, an early clinical-stage antibody-drug conjugate targeting melanotransferrin / CD228). Terms: $12 million upfront cash to Pfizer, an additional $15 million payable on the first anniversary of the effective date, plus up to $1 billion+ in aggregate milestone payments and low-double-digit tiered royalties on future net sales. Pfizer paid Medicus $2 million in development funding restricted to the CD228V program. Medicus retains sole authority and control of development, manufacture, regulatory approval, and commercialization; Pfizer holds review-and-comment rights on development plans and an option to fund development from the first registrational trial. PF-08046031 originated in the Seagen pipeline acquired by Pfizer in December 2023 and represents one of several Seagen-descended assets Pfizer has out-licensed since the acquisition.
Pfizer (NYSE: PFE) and BioNTech (NASDAQ: BNTX) announced Thursday August 27, 2026 FDA approval of the supplemental Biologics License Application for their 2026-2027 XFG-adapted Comirnaty (COVID-19 mRNA vaccine) for adults ages 65 and older and for individuals 5-64 with at least one underlying condition that puts them at high risk for severe COVID-19 outcomes. The XFG-adapted formula was designed to elicit strong immune responses against XFG, XFG.1.1, NB.1.8.1, PQ.17, PQ.2.8.1, and other contemporary lineages. Shipping to distribution centers began immediately after approval. The XFG-adapted authorization for the 2026-2027 respiratory season provides continuity with Pfizer-BioNTech's annual mRNA vaccine cadence and, indirectly, reinforces the manufacturing and lipid-nanoparticle infrastructure that Moderna is now leaning on for the intismeran neoantigen peptide-encoding cancer vaccine program.
Pfizer (NYSE: PFE) in its Q2 2026 quarterly clearout discontinued clinical development of MET-224o, an oral fully-biased ultra-long-acting GLP-1 receptor agonist in Phase 1 for chronic weight management that came over in the $10 billion Metsera acquisition completed November 2025. MET-224o was developed by D&D Pharmatech (KOSDAQ: 259540) using its ORALINK oral peptide delivery platform. D&D Pharmatech stated the discontinuation was a strategic decision by Pfizer to focus on differentiated products as a late entrant in the oral obesity market rather than a technical issue with the platform. With MET-224o out, Pfizer's oral obesity pipeline collapses to a single asset: PF-08642534 (Pfizer's name for YP05002). The pruning continues Pfizer's pattern of aggressive Metsera-portfolio triage (a GIPR prospect was also dropped in the same clearout) and narrows an already-crowded oral GLP-1 field where Lilly's Foundayo (orforglipron) and Novo's Wegovy pill (oral semaglutide 25/50 mg) are already commercial.
Seoul Economic Daily published Monday August 17, 2026 a market synthesis on the obesity drug runner-up field. Key runners-up positioning for 2027-2028 approval filings behind Eli Lilly (NYSE: LLY) and Novo Nordisk (NYSE: NVO): Structure Therapeutics (NASDAQ: GPCR) with aleniglipron (once-daily oral small-molecule GLP-1 receptor agonist) expected to initiate Phase 3 in H2 2026; Amgen (NASDAQ: AMGN) with MariTide (once-monthly injectable dual GIPR antagonist / GLP-1 agonist) now positioned as the sole obesity focus after the July 29 Q2 disclosure that Amgen halted AMG 513 Phase 1 development to concentrate resources on the MariTide MARITIME Phase 3 program; and Pfizer (NYSE: PFE) with danuglipron oral GLP-1 receptor agonist plus the Metsera acquisition pipeline. Amgen expects to apply for MariTide regulatory approval in late 2026 to early 2027. The Amgen MariTide Phase 3 program covers obesity (MARITIME-1) plus obesity and type 2 diabetes (MARITIME-2), with additional Phase 3 studies exploring cardiovascular disease, heart failure, kidney disease, and obstructive sleep apnea. The sorting of winners from losers based on Phase 3 results will begin in earnest starting next year as the field competes on efficacy, safety, delivery format, and price for market share behind Lilly's Zepbound-Mounjaro-Foundayo franchise and Novo's Wegovy-Ozempic franchise.
Pfizer (NYSE: PFE) reported Q2 2026 earnings Tuesday August 4, 2026 with revenue of $15 billion and adjusted diluted EPS of $0.77, beating analyst expectations. The company raised the midpoint of its full-year 2026 revenue guidance to $60.5-62.5 billion, up from a previous $59.5-62.5 billion range. The guidance update reflected approximately $1.5 billion in upside from non-COVID products, partially offset by a reduction in the company's forecast for COVID-19 treatments (Paxlovid and Comirnaty) now pegged at approximately $4 billion for the year. Adjusted R&D expenses increased 12% operationally to $2.7 billion, driven by increased spending on oncology and obesity product candidates. CEO Albert Bourla said in the earnings call that the obesity program is advancing with substantial momentum and that the oncology portfolio remains a source of strength. Shares rose approximately 1.86% to $25.50 following the announcement. Pfizer's obesity program includes danuglipron (oral GLP-1) and multiple next-generation candidates advanced through the Metsera acquisition; the Metsera monthly-injectable ultra-long-acting GLP-1 candidate produced up to 11% weight loss over 28 weeks in Phase 2b data reported earlier in 2026.