BioNTech SE

BNTX

NASDAQBiotechnology🇩🇪Europe

Drugs in Pipeline

Phase 3 Programs

Upcoming Catalysts

Next Catalyst

Dec 15, 2025

Drug Pipeline

Drug Name	Phase	Indication	Designations
BNT323/DB-1303	Phase 3	Endometrial Cancer	-
Nab-paclitaxel/Paclitaxel	Phase 3	Breast Neoplasms	-
BNT162b2	Phase 3	SARS-CoV-2 Infection	-
BNT113	Phase 3	Unresectable Head and Neck Squamous Cell Carcinoma	-
BNT162b1	Phase 3	SARS-CoV-2 Infection	-
Biological/Vaccine: BNT162b2 10mcg	Phase 3	SARS-CoV-2 Infection, COVID-19	-
BNT162b2 OMI	Phase 3	SARS-CoV-2 Infection	-
BNT162b2 (Omi XBB.1.5)	Phase 3	SARS-CoV-2 Infection	-
BNT162b5 Bivalent (WT/OMI BA.2)	Phase 3	SARS-CoV-2 Infection	-
Seasonal Inactivated Influenza Vaccine	Phase 3	SARS-CoV-2 Infection	-
Influenza and COVID-19 Combination A	Phase 3	Influenza	-
BNT162b2 (2025/2026 formulation)	Phase 3	COVID-19	-
Pembrolizumab	Phase 3	Non-small Cell Lung Cancer	-
BNT162b2.B.1.351	Phase 3	SARS-CoV-2 Infection	-
BNT162b2 (Omi LP.8.1)	Phase 3	COVID-19	-
Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 3 microgram dose	Phase 3	SARS-CoV-2 Virus	-
Pumitamig	Phase 3	Extensive-stage Small-cell Lung Cancer	-
BNT3212	Phase 2	Advanced Solid Tumor	-
BNT164a1	Phase 2	Tuberculosis	-
BNT165e	Phase 2	Malaria	-
Investigational Influenza Vaccine	Phase 2	Influenza,Human	-
RO7198457 intravenous (IV)	Phase 2	Colorectal Cancer Stage II	-
BNT327 Dose Level 1 (DL2)	Phase 2	Locally Advanced Breast Cancer	-
BNT324	Phase 2	Advanced Lung Cancer	-
BNT327 Dose Level 1 (DL1)	Phase 2	Extensive-stage Small-cell Lung Cancer	-
Docetaxel	Phase 2	Non-small Cell Lung Cancer	-
BNT329	Phase 2	Advanced Solid Cancers	-
BNT326	Phase 2	Advanced Solid Tumor	-
BNT162b3	Phase 2	Covid-19	-
BNT111	Phase 2	Melanoma Stage III	-
BNT162a1	Phase 2	Infections, Respiratory	-
Multivalent BNT162b2 (B.1.1.7 + B.1.617.2)	Phase 2	SARS-CoV-2 Infection	-
BNT314	Phase 2	Metastatic Colorectal Cancer	-
bivalent BNT162b2 (original/Omi BA.4/BA.5)	Phase 2	Influenza, Human	-
BNT162b2s01	Phase 2	COVID-19	-
BNT166a	Phase 2	Monkeypox	-
BNT327	Phase 2	Non-small Cell Lung Cancer	-
BNT142	Phase 2	Solid Tumor	-
BNT323	Phase 2	Locally Advanced Breast Cancer	-
Investigational COVID-19 Vaccine	Phase 2	Influenza	-

Catalyst Timeline

8 upcoming, 0 past

Phase 2Next

BNT142 Phase 2 Results Expected

December 2025~BNT142

Primary completion for BNT142 trial (NCT05262530) in Solid Tumor

Source

Phase 2

Investigational COVID-19 Vaccine Phase 2 Results Expected

Dec 22, 2025Investigational COVID-19 Vaccine

Primary completion for Investigational COVID-19 Vaccine trial (NCT06821061) in Influenza

Source

Phase 2

Investigational Influenza Vaccine Phase 2 Results Expected

Dec 22, 2025Investigational Influenza Vaccine

Primary completion for Investigational Influenza Vaccine trial (NCT06821061) in Influenza

Source

⭐Phase 3

BNT162b2 (Omi LP.8.1) Phase 3 Results Expected

Jan 6, 2026BNT162b2 (Omi LP.8.1)

Primary completion for BNT162b2 (Omi LP.8.1) trial (NCT07069309) in COVID-19

Source

Phase 2

BNT164a1 Phase 2 Results Expected

March 2026~BNT164a1

Primary completion for BNT164a1 trial (NCT05547464) in Tuberculosis

Source

⭐Phase 3

Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 3 microgram dose Phase 3 Results Expected

Jun 16, 2026Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 3 microgram dose

Primary completion for Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 3 microgram dose trial (NCT05543616) in SARS-CoV-2 Virus

Source

⭐Phase 3

BNT162b2 (2025/2026 formulation) Phase 3 Results Expected

Oct 30, 2026BNT162b2 (2025/2026 formulation)

Primary completion for BNT162b2 (2025/2026 formulation) trial (NCT07222384) in COVID-19

Source

Phase 2

RO7198457 intravenous (IV) Phase 2 Results Expected

November 2026~RO7198457 intravenous (IV)

Primary completion for RO7198457 intravenous (IV) trial (NCT04486378) in Colorectal Cancer Stage II

Source

Regulatory Approvals

BNTX News

BioNTech SE

BNTX

NASDAQBiotechnology🇩🇪Europe

Drugs in Pipeline

Phase 3 Programs

Upcoming Catalysts

Next Catalyst

Dec 15, 2025

Drug Pipeline

Drug Name	Phase	Indication	Designations
BNT323/DB-1303	Phase 3	Endometrial Cancer	-
Nab-paclitaxel/Paclitaxel	Phase 3	Breast Neoplasms	-
BNT162b2	Phase 3	SARS-CoV-2 Infection	-
BNT113	Phase 3	Unresectable Head and Neck Squamous Cell Carcinoma	-
BNT162b1	Phase 3	SARS-CoV-2 Infection	-
Biological/Vaccine: BNT162b2 10mcg	Phase 3	SARS-CoV-2 Infection, COVID-19	-
BNT162b2 OMI	Phase 3	SARS-CoV-2 Infection	-
BNT162b2 (Omi XBB.1.5)	Phase 3	SARS-CoV-2 Infection	-
BNT162b5 Bivalent (WT/OMI BA.2)	Phase 3	SARS-CoV-2 Infection	-
Seasonal Inactivated Influenza Vaccine	Phase 3	SARS-CoV-2 Infection	-
Influenza and COVID-19 Combination A	Phase 3	Influenza	-
BNT162b2 (2025/2026 formulation)	Phase 3	COVID-19	-
Pembrolizumab	Phase 3	Non-small Cell Lung Cancer	-
BNT162b2.B.1.351	Phase 3	SARS-CoV-2 Infection	-
BNT162b2 (Omi LP.8.1)	Phase 3	COVID-19	-
Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 3 microgram dose	Phase 3	SARS-CoV-2 Virus	-
Pumitamig	Phase 3	Extensive-stage Small-cell Lung Cancer	-
BNT3212	Phase 2	Advanced Solid Tumor	-
BNT164a1	Phase 2	Tuberculosis	-
BNT165e	Phase 2	Malaria	-
Investigational Influenza Vaccine	Phase 2	Influenza,Human	-
RO7198457 intravenous (IV)	Phase 2	Colorectal Cancer Stage II	-
BNT327 Dose Level 1 (DL2)	Phase 2	Locally Advanced Breast Cancer	-
BNT324	Phase 2	Advanced Lung Cancer	-
BNT327 Dose Level 1 (DL1)	Phase 2	Extensive-stage Small-cell Lung Cancer	-
Docetaxel	Phase 2	Non-small Cell Lung Cancer	-
BNT329	Phase 2	Advanced Solid Cancers	-
BNT326	Phase 2	Advanced Solid Tumor	-
BNT162b3	Phase 2	Covid-19	-
BNT111	Phase 2	Melanoma Stage III	-
BNT162a1	Phase 2	Infections, Respiratory	-
Multivalent BNT162b2 (B.1.1.7 + B.1.617.2)	Phase 2	SARS-CoV-2 Infection	-
BNT314	Phase 2	Metastatic Colorectal Cancer	-
bivalent BNT162b2 (original/Omi BA.4/BA.5)	Phase 2	Influenza, Human	-
BNT162b2s01	Phase 2	COVID-19	-
BNT166a	Phase 2	Monkeypox	-
BNT327	Phase 2	Non-small Cell Lung Cancer	-
BNT142	Phase 2	Solid Tumor	-
BNT323	Phase 2	Locally Advanced Breast Cancer	-
Investigational COVID-19 Vaccine	Phase 2	Influenza	-