BioNTech SE

Entry

Multiple pumitamig combination data readouts expected in 2026 · Clinical trial results (readout / topline data)

Drug

Pumitamig (BNT327)

For

Solid tumors (NSCLC, SCLC, TNBC, CRC, gastric, others)

Stage

Phase 2/3 · a combined mid- to late-stage study

When

2026 · the company gave a window, not a day

Source note

BioNTech Aug 4, 2026 Q2 release; company guides only to '2026' for further pumitamig combination readouts.

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• Source: biospace.com ↗ — where this entry was taken from
• SEC filings (8-K) ↗ — press releases are attached to 8-K filings
• ClinicalTrials.gov ↗ — trials of this drug
• BNTX headlines on this site

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Entry

Gotistobart (BNT316) Phase 3 interim analysis in squamous NSCLC · Clinical trial results (readout / topline data)

Drug

gotistobart (BNT316/ONC-392, anti-CTLA-4)

For

Squamous non-small cell lung cancer

Stage

Phase 3 · the last stage before a drug can be approved

When

H2 2026 · the company gave a window, not a day

Source note

BioNTech guidance: 'First interim analysis from Stage 2 of the two-stage Phase 3 clinical trial is expected in 2026' — encoded H2 2026 as the remaining window of the guided year.

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• Source: biontech.com ↗ — where this entry was taken from
• SEC filings (8-K) ↗ — press releases are attached to 8-K filings
• ClinicalTrials.gov ↗ — trials of this drug
• BNTX headlines on this site

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Entry

BNT113 AHEAD-MERIT Phase 3 first interim analysis in HPV16+ head and neck cancer · Clinical trial results (readout / topline data)

Drug

BNT113 (FixVac mRNA immunotherapy) + pembrolizumab

For

Unresectable recurrent/metastatic PD-L1+, HPV16+ head and neck squamous cell carcinoma

Stage

Phase 2/3 · a combined mid- to late-stage study

When

H2 2026 · the company gave a window, not a day

Source note

BioNTech FY2025 report (March 2026): 'data are expected in 2026 from the first interim analysis of the Phase 3 part'; encoded H2 2026 as the remaining window of the guided year.

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• Source: biontech.com ↗ — where this entry was taken from
• SEC filings (8-K) ↗ — press releases are attached to 8-K filings
• ClinicalTrials.gov ↗ — trials of this drug
• BNTX headlines on this site

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Entry

Planned BLA filing for trastuzumab pamirtecan (BNT323) · Company milestone

Drug

trastuzumab pamirtecan (BNT323/DB-1303)

For

HER2-expressing endometrial cancer (initial filing indication; breast strategy pending data)

Stage

BLA preparation (Breakthrough Therapy designation)

When

H2 2026 · the company gave a window, not a day

Source note

BioNTech and DualityBio 'plan to file a biologics license application... in 2026'; optimal regulatory path across endometrial and breast indications to be finalized on complete data. Encoded H2 2026 (remaining window).

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• Source: biontech.com ↗ — where this entry was taken from
• SEC filings (8-K) ↗ — press releases are attached to 8-K filings
• ClinicalTrials.gov ↗ — trials of this drug
• BNTX headlines on this site

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Entry

Trastuzumab pamirtecan (BNT323) DYNASTY-Breast02 primary analysis · Clinical trial results (readout / topline data)

Drug

trastuzumab pamirtecan (BNT323/DB-1303, HER2 ADC)

For

HR+/HER2-low metastatic breast cancer

Stage

Phase 3 · the last stage before a drug can be approved

When

Q4 2026 · the company gave a window, not a day

Source note

BioNTech Q2 2026 press release: 'Primary analysis is expected in the fourth quarter 2026' — one of three guided 2026 late-stage readouts (immunomodulator, ADC, mRNA immunotherapy).

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• Source: biontech.com ↗ — where this entry was taken from
• SEC filings (8-K) ↗ — press releases are attached to 8-K filings
• ClinicalTrials.gov ↗ — trials of this drug
• BNTX headlines on this site

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Entry

Pumitamig + elfetabart drozuntecan late-breaking oral at WCLC 2026 · Data presented at a medical meeting

Drug

Pumitamig (BNT327) + elfetabart drozuntecan (BNT324)

For

Advanced/metastatic lung cancer

Stage

Phase 1/2 · an early study that checks safety and takes a first look at effect

When

Sep 15, 2026

Source note

BioNTech Aug 20, 2026 PR (WCLC Seoul, Sept 12-15): late-breaking oral OA14.01 — first global combination data for a PD-(L)1xVEGF bispecific plus an ADC in lung cancer.

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• Source: stocktitan.net ↗ — where this entry was taken from
• SEC filings (8-K) ↗ — press releases are attached to 8-K filings
• ClinicalTrials.gov ↗ — trials of this drug
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Entry

Gotistobart PRESERVE-003 stage 1 updated OS mini oral at WCLC 2026 · Data presented at a medical meeting

Drug

Gotistobart (BNT316/ONC-392)

For

Metastatic squamous NSCLC after PD-(L)1 progression

Stage

Phase 3 · the last stage before a drug can be approved

When

Sep 14, 2026

Source note

BioNTech Aug 20, 2026 PR: updated overall survival from stage 1 of PRESERVE-003 (gotistobart vs docetaxel) as a mini oral at WCLC; pivotal stage 2 ongoing with first interim expected in 2026.

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• Source: stocktitan.net ↗ — where this entry was taken from
• SEC filings (8-K) ↗ — press releases are attached to 8-K filings
• ClinicalTrials.gov ↗ — trials of this drug
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Entry

European Commission authorizes XFG-adapted COVID-19 vaccine for 2026-2027 · Regulatory approval

Drug

Pfizer-BioNTech XFG-adapted COVID-19 vaccine (Comirnaty)

For

Prevention of COVID-19, ages 6 months and older

Stage

Marketed / strain update

When

Jul 29, 2026

Source note

The European Commission granted marketing authorization for the Pfizer-BioNTech 2026-2027 COVID-19 vaccine formula targeting the XFG variant for people 6 months and older, following a CHMP recommendation on July 23, 2026. The authorization covers all 27 EU member states plus Iceland, Liechtenstein and Norway.

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• Source: sec.gov ↗ — where this entry was taken from
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• ClinicalTrials.gov ↗ — trials of this drug
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Entry

Pumitamig ROSETTA Lung-02 interim Phase 2 shows high response rates at ASCO · Data presented at a medical meeting

Drug

Pumitamig (BNT327/BMS-986545)

For

First-line advanced non-small cell lung cancer

Stage

Phase 2/3 · a combined mid- to late-stage study

When

May 30, 2026

Source note

BioNTech and Bristol Myers Squibb reported interim Phase 2 data from the global Phase 2/3 ROSETTA Lung-02 trial of pumitamig plus chemotherapy in previously untreated advanced NSCLC, with confirmed ORR of 57.1% in non-squamous and 68.4% in squamous disease and responses across all PD-L1 levels.

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• Source: stocktitan.net ↗ — where this entry was taken from
• SEC filings (8-K) ↗ — press releases are attached to 8-K filings
• ClinicalTrials.gov ↗ — trials of this drug
• BNTX headlines on this site

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Entry

Trastuzumab pamirtecan met primary ORR endpoint in HER2+ endometrial cancer · Clinical trial results (readout / topline data)

Drug

Trastuzumab pamirtecan (BNT323/DB-1303)

For

HER2-expressing recurrent/advanced endometrial cancer

Stage

Phase 1/2 · an early study that checks safety and takes a first look at effect

When

Apr 11, 2026

Source note

BioNTech and DualityBio reported that the Phase 2 endometrial cancer cohort of trastuzumab pamirtecan (BNT323/DB-1303) met its primary ORR endpoint, with confirmed ORR of 49.3% in centrally tested prior-checkpoint-inhibitor patients and median PFS of 8.1 months. Data were presented in an oral session at SGO 2026.

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• Source: sec.gov ↗ — where this entry was taken from
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• ClinicalTrials.gov ↗ — trials of this drug
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Entry

Gotistobart Phase 3 stage 1 cut risk of death 54% in squamous NSCLC at ELCC · Data presented at a medical meeting

Drug

Gotistobart (BNT316/ONC-392); pumitamig (BNT327)

For

Second-line or later squamous non-small cell lung cancer

Stage

Phase 3 · the last stage before a drug can be approved

When

Mar 24, 2026

Source note

Ahead of ELCC 2026, BioNTech disclosed that the non-pivotal stage 1 portion of the global Phase 3 PRESERVE-003 trial of gotistobart showed a 54% reduction in risk of death versus standard-of-care chemotherapy in second-line or later squamous NSCLC. Pumitamig updates from three China trials were also presented.

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Entry

BNT162b2 Phase 3 interim: >90% efficacy · Clinical trial results (readout / topline data)

Drug

BNT162b2 (Comirnaty)

For

COVID-19 prevention

Stage

Phase 3 · the last stage before a drug can be approved

When

Nov 9, 2020

Source note

Pfizer/BioNTech announced first interim efficacy analysis of their COVID-19 vaccine trial.

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• SEC filings (8-K) ↗ — press releases are attached to 8-K filings
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