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Phase 3Data readout

BNT316 (ONC-392)

Non-small cell lung carcinoma, Cancer, Lung cancer

BNTXBioNTech SE
Expected catalystSeptember 14, 2026Company guidance: Sep 14, 2026

Catalyst overview

Event details

Drug or asset
BNT316 (ONC-392)
Development stage
Phase 3
Event type
Data readout
Indication
Non-small cell lung carcinoma, Cancer, Lung cancer

Research summary

What is being tracked?

This catalyst tracks a Phase 3 data readout for BNT316 (ONC-392) in Non-small cell lung carcinoma, Cancer, Lung cancer. The expected timing is based on the latest available company guidance and may change.

Development notes

Collaboration w/ OncoC4. Positive Ph1/2 data from an expansion cohort at ASCO 2023 and in SITC 2023. 6/29/23- Initiated Ph3. Preliminary Phase 2 data at ESMO '24 on 9/15. 03/24/26:- Stage 1 Ph3 PRESERVE-003 showed OS benefit in 2L+ sqNSCLC; ELCC March 27, 2026. Pivotal stage ongoing. 08/20/26:- Updated PRESERVE-003 stage 1 OS to present at WCLC Sep 14, 2026.

Verification

Primary source

Confirm timing and program details against the company announcement or filing.

Open source

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Phase 1/2

Pumitamig/Elfetabart Drozuntecan (BNT327/BMS986545 + BNT324/DB-1311) (Bispecific ADC Combination)

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Company

BioNTech SE

BNTX · NasdaqGS
Industry
Biotechnology
Pipeline assets
30
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Updated Aug 23, 2026. Dates can change; this is not investment advice.

Disclaimer: Biotech Stock Intel is an independent research platform. Information is provided for informational purposes only and is not investment or medical advice. Always verify catalyst dates against primary sources and conduct your own research.
Biotech Stock Intel© 2026 Biotech Stock Intel
AboutMethodologyTermsPrivacy