BNTX

BioNTech discontinues a phase II colorectal cancer study after updated data show an efficacy imbalance, while a pancreatic cancer study continues.

BioNTech SE maintains a Strong Buy rating, driven by robust late-stage oncology pipeline momentum and strategic partnerships. BNTX's next-gen anti-CTLA-4 gotistobart and PD-L1xVEGF-A bispecific antibody pumitamig have multiple pivotal trial catalysts, with key data readouts expected at WCLC 2026. COMIRNATY's XFG variant expansion provides near-term revenue, but COVID-19 vaccine sales face competitive and demand headwinds, reflected in lowered 2026 guidance.

A single trial readout is reshuffling the mRNA vaccine trade this morning. BioNTech SE (NASDAQ:BNTX | BNTX Price Prediction) stock is down 8% to $102.

2026-2027 COVID-19 vaccine formula targets the XFG variant, in line with FDA guidance to more closely match contemporary circulating variants Shipping will begin immediately to ensure rapid access to this season's vaccine  NEW YORK and MAINZ, GERMANY, August 27, 2026 — Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for the companies' 2026-2027 COVID-19 vaccine formula targeting the XFG variant (COMIRNATY® XFG; COVID-19 Vaccine, mRNA) for use in adults ages 65 years and older, as well as in individuals ages 5 through 64 years with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.1 The FDA approval is based on the cumulative body of evidence previously submitted by Pfizer and BioNTech that includes clinical, non-clinical and real-world data supporting the safety and effectiveness of COMIRNATY, as well as manufacturing/quality and non-clinical data showing that the XFG-adapted COVID-19 vaccine generated strong immune responses against currently circulating SARS-CoV-2 variants, including XFG, XFG.1.1, NB.1.8.1, PQ.17, PQ.2.8.1 and other contemporary lineages.2 The selection of the XFG variant is based on guidance from the FDA as the preferred composition of COVID-19 vaccines for use in the U.S. beginning in fall 2026.3 This season's Pfizer and BioNTech COVID-19 vaccine will begin shipping immediately and will be available in pharmacies, hospitals, and clinics across the U.S. in the coming days. To date, more than five billion doses of COMIRNATY have been distributed globally, and it continues to demonstrate a favorable safety and efficacy profile supported by extensive real-world evidence as well as clinical, non-clinical, pharmacovigilance, and manufacturing data.2 The COVID-19 vaccines by Pfizer and BioNTech are based on BioNTech's proprietary mRNA technology and were developed by both companies.

Moderna stock is giving back a large chunk of Tuesday's rally. The pullback reopens a question that a summer melt-up has largely papered over: what does a market capitalization near $59 billion actually value on this income statement?

Two names built on the same platform have stopped moving together this morning. Moderna (NASDAQ:MRNA | MRNA Price Prediction) stock is up 11% to $154.15, a Tuesday morning session standing well apart from anything happening across the broader biotech sector.

On August 19, 2026, Merck (NYSE:MRK | MRK Price Prediction) and Moderna (NASDAQ:MRNA) announced positive topline Phase 3 results from INTerpath-001 for intismeran autogene, an individualized neoantigen therapy paired with Keytruda in resected melanoma.

Moderna (NASDAQ:MRNA | MRNA Price Prediction) stock is down 7% to $135.22 in Monday morning trading, cooling off after one of the most explosive runs in biotech this year.

The mRNA trade is whipsawing for a third straight session as the market keeps repricing a single trial readout with no fresh clinical information hitting the tape Friday.

Shares of Moderna (NASDAQ:MRNA | MRNA Price Prediction) stock are down 18% to $142.70 in Thursday midday trading, unwinding a meaningful piece of Wednesday's historic 177% rally.