BNTX

Moderna (NASDAQ:MRNA | MRNA Price Prediction) shares are surging Monday morning after the company announced that its Phase 3 adjuvant melanoma study for intismeran autogene, an investigational messenger RNA individualized neoantigen therapy, was selected for a Presidential Symposium slot at

Cancer vaccine momentum is doing the work for Moderna (NASDAQ:MRNA | MRNA Price Prediction) once again on Thursday, extending one of the sharpest one-month runs in large-cap biotech this year without a fresh disclosure attached to it.

BioNTech said on Monday ​that a late-stage ‌trial showed its drug candidate gotistobart ​led to a ​clinically meaningful overall survival ⁠benefit in ​a certain form of ​lung cancer compared with standard treatment.

MAINZ, Germany, and ROCKVILLE, USA, September 14, 2026 – BioNTech SE (Nasdaq: BNTX, “BioNTech”) and OncoC4, Inc. (“OncoC4”) today announced the first median overall survival (“OS”) data from the non-pivotal stage 1 of the global randomized PRESERVE-003 Phase 3 clinical trial (NCT05671510) of gotistobart (also known as BNT316 or ONC-392), in patients with squamous non-small lung cancer (“NSCLC”) whose disease progressed on prior immunotherapy and chemotherapy. Gotistobart is an investigational CTLA-4-targeting immunotherapy designed to selectively deplete regulatory T cells (“Tregs”) within the tumor microenvironment and restore anti-tumor immune activity.

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.