Biontech SE (BNTX) — Upcoming Catalysts

FDA PDUFA dates, advisory-committee meetings, and Phase 2/3 readout windows for Biontech SE, built from public data lanes (ClinicalTrials.gov and official sources). Each row links to its source.

For informational purposes only — not investment advice. Track BNTX live on Mooboard →

31–90 days1

  • Nov 2026
    Biontech SE(BNTX)Phase 2/3 readout
    RO7198457 intravenous (IV) · Phase 2 · Colorectal Cancer Stage II; Colorectal Cancer Stage III
    NCT04486378: A Phase II Clinical Trial Comparing the Efficacy of RO7198457 Versus Watchful Waiting in Patients With ctDNA-positive, Resected Stage II (High Risk) and Stage III Colorectal Cancer. Primary completion 2026-11 (estimated); status ACTIVE_NOT_RECRUITING.
    ClinicalTrials.gov ↗

Later22

  • Apr 20, 2027
    Biontech SE(BNTX)Phase 2/3 readout
    BNT162b2 · Phase 3 · COVID-19 Vaccines
    NCT07798648: A Study of COVID-19 Vaccine(s) in Children and Adults. Primary completion 2027-04-20 (estimated); status NOT_YET_RECRUITING.
    ClinicalTrials.gov ↗
  • Jun 2027
    Biontech SE(BNTX)Phase 2/3 readout
    BNT327 Dose Level 1 (DL1) · Phase 2 · Extensive-stage Small-cell Lung Cancer; Small-cell Lung Cancer
    NCT06449209: Safety, Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With Chemotherapy. Primary completion 2027-06 (estimated); status ACTIVE_NOT_RECRUITING.
    ClinicalTrials.gov ↗
  • Jun 2027
    Biontech SE(BNTX)Phase 2/3 readout
    BNT166a · Phase 2 · Mpox (Monkeypox); Smallpox
    NCT07379580: A Randomized Clinical Trial Investigating the Safety, Reactogenicity, and Immunogenicity After Immunization With an mRNA-based Mpox Vaccine Candidate in Africa. Primary completion 2027-06 (estimated); status RECRUITING.
    ClinicalTrials.gov ↗
  • Nov 2027
    Biontech SE(BNTX)Phase 2/3 readout
    BNT3212 · Phase 1 / Phase 2 · Advanced Solid Tumor
    NCT07147348: A First-in-human, Dose Escalation and Indication Expansion Study of BNT3212 as Monotherapy or in Combination With BNT327 in Adults With Advanced Solid Tumors. Primary completion 2027-11 (estimated); status RECRUITING.
    ClinicalTrials.gov ↗
  • Dec 2027
    Biontech SE(BNTX)Phase 2/3 readout
    Pumitamig · Phase 2 · Pancreatic Ductal Adenocarcinoma (PDAC)
    NCT07255404: A Clinical Trial Testing the Safety of Pumitamig (an Investigational Drug) and How Well it Works When Combined With Chemotherapy for People Who Have Not Been Treated Yet for Pancreatic Cancer. Primary completion 2027-12 (estimated); status RECRUITING.
    ClinicalTrials.gov ↗
  • Jan 2028
    Biontech SE(BNTX)Phase 2/3 readout
    Pumitamig · Phase 2 · Recurrent Glioblastoma
    NCT07297212: A Clinical Trial Testing the Safety of the Investigational Drug Pumitamig (BNT327) and How Well it Works in Patients With Recurrent Glioblastoma. Primary completion 2028-01 (estimated); status RECRUITING.
    ClinicalTrials.gov ↗
  • Mar 2028
    Biontech SE(BNTX)Phase 2/3 readout
    BNT323/DB-1303 · Phase 3 · Endometrial Cancer
    NCT06340568: A Clinical Study of the Anti-cancer Effects of an Investigational Therapy or Chemotherapy in Patients With Recurring Uterine Cancer. Primary completion 2028-03 (estimated); status RECRUITING.
    ClinicalTrials.gov ↗
  • Mar 2028
    Biontech SE(BNTX)Phase 2/3 readout
    BNT326 · Phase 1 / Phase 2 · Advanced Solid Tumor
    NCT07070232: A Clinical Study to Test if an Investigational Treatment Called BNT326 is Safe and Potentially Beneficial When Used Alone or in Combination With Other Investigational Treatments Such as BNT327, for People With Advanced Malignant Tumors. Primary completion 2028-03 (estimated); status RECRUITING.
    ClinicalTrials.gov ↗
  • Aug 2028
    Biontech SE(BNTX)Phase 2/3 readout
    BNT327 Dose Level 1 (DL1) · Phase 2 · Locally Advanced Breast Cancer; Triple Negative Breast Cancer
    NCT06449222: Safety and Preliminary Effectiveness of BNT327, an Investigational Therapy for Breast Cancer, When Given in Combination With Chemotherapy. Primary completion 2028-08 (estimated); status ACTIVE_NOT_RECRUITING.
    ClinicalTrials.gov ↗
  • Aug 2028
    Biontech SE(BNTX)Phase 2/3 readout
    BNT113 · Phase 2 / Phase 3 · Unresectable Head and Neck Squamous Cell Carcinoma; Metastatic Head and Neck Cancer
    NCT04534205: A Clinical Trial Investigating the Safety, Tolerability, and Therapeutic Effects of BNT113 in Combination With Pembrolizumab Versus Pembrolizumab Alone for Patients With a Form of Head and Neck Cancer Positive for Human Papilloma Virus 16 and Expressing the Protein PD-L1. Primary completion 2028-08 (estimated); status ACTIVE_NOT_RECRUITING.
    ClinicalTrials.gov ↗
  • Sep 2028
    Biontech SE(BNTX)Phase 2/3 readout
    BNT324 · Phase 1 / Phase 2 · Advanced Lung Cancer
    NCT06892548: A Clinical Study to Investigate the Efficacy and Safety of an Investigational Combination Therapy With BNT324 and BNT327 in Patients With Advanced Lung Cancer. Primary completion 2028-09 (estimated); status RECRUITING.
    ClinicalTrials.gov ↗
  • Oct 2028
    Biontech SE(BNTX)Phase 2/3 readout
    Pumitamig · Phase 2 · Non-small Cell Lung Cancer
    NCT06841055: Safety and Preliminary Efficacy of Pumitamig (BNT327), an Investigational Therapy for Patients With Non-small Cell Lung Cancer in Combination With Chemotherapy as First-line or Second-line Treatment. Primary completion 2028-10 (estimated); status RECRUITING.
    ClinicalTrials.gov ↗
  • Nov 2028
    Biontech SE(BNTX)Phase 2/3 readout
    BNT326 · Phase 1 / Phase 2 · Non-small Cell Lung Cancer
    NCT07111520: A Clinical Trial to Test if an Investigational Combination Therapy With BNT326 and BNT327 is Safe and Potentially Beneficial for People With Advanced Non-small Cell Lung Cancer (NSCLC). Primary completion 2028-11 (estimated); status RECRUITING.
    ClinicalTrials.gov ↗
  • Dec 2028
    Biontech SE(BNTX)Phase 2/3 readout
    Pumitamig · Phase 3 · Extensive-stage Small-cell Lung Cancer
    NCT06712355: Safety and Efficacy of BNT327, an Investigational Therapy in Combination With Chemotherapy for Patients With Untreated Small-cell Lung Cancer. Primary completion 2028-12 (estimated); status RECRUITING.
    ClinicalTrials.gov ↗
  • Jan 2029
    Biontech SE(BNTX)Phase 2/3 readout
    Pumitamig · Phase 2 / Phase 3 · Non-small Cell Lung Cancer
    NCT06712316: Safety, Efficacy, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer. Primary completion 2029-01 (estimated); status RECRUITING.
    ClinicalTrials.gov ↗
  • Aug 2029
    Biontech SE(BNTX)Phase 2/3 readout
    BNT323 · Phase 1 / Phase 2 · Locally Advanced Breast Cancer; Unresectable Breast Carcinoma
    NCT06827236: A Clinical Study to Find the Optimal Dose of an Investigational Treatment Called BNT323 When Used in Combination With Another Investigational Treatment, BNT327, and to Test if That Combination Treatment is Safe and Beneficial for Patients With Advanced Breast Cancer. Primary completion 2029-08 (estimated); status RECRUITING.
    ClinicalTrials.gov ↗
  • Dec 2029
    Biontech SE(BNTX)Phase 2/3 readout
    Pumitamig · Phase 3 · Breast Neoplasms
    NCT07173751: ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer. Primary completion 2029-12 (estimated); status RECRUITING.
    ClinicalTrials.gov ↗
  • May 2030
    Biontech SE(BNTX)Phase 2/3 readout
    BNT329 · Phase 1 / Phase 2 · Advanced Solid Cancers
    NCT07186842: A Clinical Trial to Test if the Investigational Drug BNT329 is Safe and Potentially Beneficial for People With Advanced Solid Tumors Known to Express the Tumor Marker CA19-9. Primary completion 2030-05 (estimated); status RECRUITING.
    ClinicalTrials.gov ↗
  • Oct 2030
    Biontech SE(BNTX)Phase 2/3 readout
    BNT3214 · Phase 1 / Phase 2 · Advanced Solid Tumor Cancer
    NCT07455734: Early-phase Trial to Assess the Safety and Preliminary Efficacy of BNT3214 in Adults With Advanced Solid Tumors. Primary completion 2030-10 (estimated); status RECRUITING.
    ClinicalTrials.gov ↗
  • Dec 2030
    Biontech SE(BNTX)Phase 2/3 readout
    BNT314 · Phase 1 / Phase 2 · Metastatic Colorectal Cancer
    NCT07079631: A Clinical Study to Test if an Investigational Treatment Called BNT314 When Used in Combination With Another Investigational Treatment Pumitamig (BNT327) and Chemotherapy, is Beneficial and Safe for Patients With Advanced Colorectal Cancer. Primary completion 2030-12 (estimated); status RECRUITING.
    ClinicalTrials.gov ↗
  • Feb 2031
    Biontech SE(BNTX)Phase 2/3 readout
    BNT324 · Phase 3 · Metastatic Castration-resistant Prostate Cancer
    NCT07365995: A Phase III Trial of BNT324 Versus Docetaxel in Metastatic Castration-resistant Prostate Cancer. Primary completion 2031-02 (estimated); status RECRUITING.
    ClinicalTrials.gov ↗
  • Apr 2031
    Biontech SE(BNTX)Phase 2/3 readout
    BNT317 DL1 · Phase 1 / Phase 2 · Advanced Solid Tumor
    NCT06750185: Safety and Preliminary Effectiveness of BNT317, an Investigational Therapy for Advanced Solid Tumors. Primary completion 2031-04 (estimated); status RECRUITING.
    ClinicalTrials.gov ↗

How Biontech SE has moved — past-year price reactions

How binary is BNTX? Its typical daily move, how often it swings ±10%, and its biggest single-day moves over the last year — useful context for sizing around a catalyst.

1.2%
typical day (1Y)
3
±10% days
45.9%
annualized vol
249
trading days
Largest single-day moves
  • +22%2026-08-19no matched headline
  • -17.9%2026-03-10no matched headline
  • +11.8%2026-01-21no matched headline
  • -8.4%2026-08-28no matched headline
  • +8.3%2026-03-11no matched headline
  • -7%2025-11-13no matched headline

Real daily price moves over the past year — not every move is a catalyst, and headlines (where shown) are a possible same-day driver, not confirmed causation.

Biontech SE — active clinical pipeline

Biontech SE's registered Phase 1–3 programs by asset and indication, derived from ClinicalTrials.gov.

22 assets32 programsPh1 6Ph2 17Ph3 8· 1 post-marketing (Ph4)
AreasOncologyInfectiousOther
PumitamigOncology
Phase 2
Non-small Cell Lung CancerPancreatic Ductal Adenocarcinoma (PDAC)Recurrent Glioblastoma
Phase 3
Breast NeoplasmsExtensive-stage Small-cell Lung CancerNon-small Cell Lung Cancer
BNT324Oncology
Phase 2
Advanced Lung Cancer
Phase 3
Metastatic Castration-resistant Prostate Cancer
BNT113Oncology
Phase 3
Unresectable Head and Neck Squamous Cell Carcinoma
BNT162b2Infectious
Phase 3
COVID-19 Vaccines
BNT162b2 VaccineInfectious
Phase 3
COVID-19
BNT323/DB-1303Oncology
Phase 3
Endometrial Cancer
BNT314Oncology
Phase 1
Advanced Malignant Solid Tumor
Phase 2
Metastatic Colorectal Cancer
BNT326Oncology
Phase 2
Advanced Solid TumorNon-small Cell Lung Cancer
BNT327 Dose Level 1 (DL1)Oncology
Phase 2
Extensive-stage Small-cell Lung CancerLocally Advanced Breast Cancer
BNT164a1Infectious
Phase 2
Tuberculosis
BNT166aOther
Phase 2
Mpox (Monkeypox)
BNT317 DL1Oncology
Phase 2
Advanced Solid Tumor
BNT3212Oncology
Phase 2
Advanced Solid Tumor
BNT3214Oncology
Phase 2
Advanced Solid Tumor Cancer
BNT323Oncology
Phase 2
Locally Advanced Breast Cancer
BNT329Oncology
Phase 2
Advanced Solid Cancers
RO7198457 intravenous (IV)Oncology
Phase 2
Colorectal Cancer Stage II
BNT116Oncology
Phase 1
Non-Small Cell Lung Cancer
BNT163Other
Phase 1
Genital Herpes Simplex Type 2
BNT168Infectious
Phase 1
HIV -1 Infection
BNT351Infectious
Phase 1
HIV -1 Infection
CLDN6 CAR-TOncology
Phase 1
Solid Tumor

Active registered Phase 1–3 trials from ClinicalTrials.gov — not the company's official IR pipeline (no preclinical or undisclosed assets). Grouped by trial intervention name; therapeutic area is auto-categorized. Each indication links to its trial. Molecular targets sourced from ChEMBL (EMBL-EBI).

Targets from a ChEMBL (EMBL-EBI) snapshot dated 2026-08-20 · 310/1701 assets resolved when it was built

See the full biopharma catalyst calendar across all covered companies.