BioNTech SE reports recurring developments as a Germany-based biotechnology company whose ADSs trade on Nasdaq. Company news centers on oncology pipeline progress across immunomodulators, antibody-drug conjugates and mRNA cancer immunotherapies, including lung cancer programs such as pumitamig and gotistobart, as well as COVID-19 vaccine activity tied to its commercial vaccine franchise.
Updates also cover quarterly and annual financial results, research and development spending, corporate presentations, capital allocation actions such as ADS repurchase authorizations, and shareholder meeting or governance matters. BioNTech news frequently links clinical data, partnership activity and operating priorities to its broader objective of building a multi-product biotechnology business.
BioNTech (Nasdaq: BNTX) reported positive Phase 2 results for trastuzumab pamirtecan in HER2-expressing, recurrent endometrial cancer on April 11, 2026. The cohort (n=145) showed a confirmed ORR of 47.9% in centrally tested patients and mPFS of 8.1 months, with a median DoR of 10.3 months.
The safety profile was manageable; grade ≥3 TRAEs occurred in 46.9% and grade ≥3 ILD/pneumonitis in 4.8%. BioNTech and DualityBio plan a BLA filing in 2026 and an ongoing Phase 3 confirmatory trial is underway.
BioNTech (Nasdaq: BNTX) will present late-stage lung cancer data at ELCC 2026 (March 25-28), highlighting updates on pumitamig, gotistobart and the HER3-targeted ADC BNT326/YL202. Key clinical notes include a reported 54% reduction in risk of death for gotistobart versus chemotherapy in stage 1 PRESERVE-003 and multiple China-based trial updates for pumitamig supporting ongoing global Phase 2/3 and Phase 3 programs.
The portfolio now spans 16 ongoing lung cancer trials, including four pivotal Phase 3 studies and five novel-novel combination trials.
BioNTech (Nasdaq: BNTX) reported full year 2025 revenues of €2.87 billion, an IFRS net loss of €1.14 billion (adjusted net loss €117.1 million) and cash, cash equivalents and investments of €17.24 billion as of December 31, 2025.
The company expects 2026 revenues of €2.0–2.3 billion, adjusted R&D of €2.2–2.5 billion and adjusted SG&A of €700–800 million. Co-founders will form an independent mRNA company with a management transition by end-2026. Multiple late-stage oncology readouts including pumitamig programs are planned for 2026.
BioNTech (Nasdaq: BNTX) announced that co-founders Prof. Ugur Sahin and Prof. Özlem Türeci will form an independent company to develop next-generation mRNA innovations, with BioNTech contributing related rights and technologies for a minority stake and possible milestones/royalties.
A binding agreement is expected by end H1/2026, founders will transition to the new company by end 2026, and BioNTech expects 15 ongoing Phase 3 oncology trials and multiple late-stage readouts in 2026.
BioNTech (Nasdaq: BNTX) will report fourth quarter and full year 2025 financial results on March 10, 2026. A live conference call and webcast for investors and analysts is scheduled for 8:00 a.m. ET (1:00 p.m. CET) that day.
Slides and audio will be available on the company website, with a replay archived for 30 days.
BioNTech (Nasdaq: BNTX) appointed Kylie Jimenez to the Management Board as Chief People Officer, effective March 1, 2026. The newly created role will lead people strategy to support BioNTech’s goal to become a multi-product oncology company by 2030.
Jimenez joins from Georg Fischer with more than 20 years of global HR experience and will be based in Mainz, Germany.
BioNTech (Nasdaq: BNTX) outlined 2026 priorities at the 44th J.P. Morgan Healthcare Conference, emphasizing late-stage oncology acceleration, combination therapy programs, and disease-area focus across lung, breast, GI, GU and gynecologic cancers. The company expects 15 Phase 3 trials by year-end 2026 and seven late-stage data readouts in 2026, with at least 17 late-stage readouts by 2030+. BioNTech reported a strong balance sheet of €17.2 billion in cash and investments as of Dec 31, 2025, updated 2025 revenue guidance to €2.6–2.8 billion, and said it does not anticipate oncology product revenues in 2026. Presentation webcast scheduled for Jan 13, 2026.
BioNTech (Nasdaq: BNTX) closed its exchange offer to acquire CureVac on December 18, 2025, after a Subsequent Offering Period expired at 12:01 a.m. ET.
Approximately 86.75% of CureVac shares were validly tendered; BioNTech expects to complete compulsory acquisition of remaining shares in January 2026. CureVac shares will no longer trade following the post-offer reorganization. Management changes at CureVac were implemented with former CureVac board members voluntarily resigning and three BioNTech executives appointed to the CureVac management board.
BioNTech said the acquisition complements its proprietary capabilities in mRNA design, delivery formulations, and mRNA manufacturing and supports its oncology strategy, including joint development of pumitamig (BNT327/BMS986545) with Bristol Myers Squibb.
BioNTech (Nasdaq: BNTX) and Bristol Myers Squibb announced interim global Phase 2 data for pumitamig (BNT327/BMS986545), a PD-L1xVEGF-A bispecific antibody, combined with chemotherapy in locally advanced/metastatic triple-negative breast cancer (TNBC) as of the October 1, 2025 cut-off.
Key results in 39 efficacy-evaluable 1L/2L patients (Cohort 1): confirmed ORR 61.5%, unconfirmed ORR 71.8%, DCR 92.3%, and 9-month PFS rate 59.3%. Efficacy was similar across PD-L1 levels (CPS ≥10 and <10). Grade ≥3 treatment-related adverse events occurred in ~38–43% of patients; no pumitamig-related deaths were reported. Data support dose selection for the pivotal Phase 3 ROSETTA BREAST-01 trial.
BioNTech (Nasdaq: BNTX) and OncoC4 reported that selective Treg modulator gotistobart (BNT316/ONC-392) showed a clinically meaningful overall survival benefit versus docetaxel in the non-pivotal stage of the global Phase 3 PRESERVE-003 trial in previously treated metastatic squamous NSCLC.
At a 14.5-month median follow-up, median OS with gotistobart was not reached versus 10 months with docetaxel; 12-month OS was 63.1% vs 30.3%. Hazard ratio for death was 0.46 (95% CI 0.25–0.84) with nominal p=0.0102. Safety remained manageable; grade ≥3 TRAEs were 42.2% vs 48.8%.