Drugs / BNT326
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Clinical hold | US (FDA) | — | progesterone-receptor positive breast cancer | 2024-06-17 | “is on partial clinical hold by the U.S. FDA, as announced on June 17, 2024.” biontech.com ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT07111520 | Sep 2025 → Jan 2029 expected | non-small cell lung carcinoma | BioNTech SE | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07070232 | Aug 2025 → Mar 2028 expected | neoplasm | BioNTech SE | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2026-03-24 | BioNTech SE | Results BioNTech Clinical Data at ELCC 2026 Highlight Potential of Differentiated Late-Stage Portfolio in Lung Cancer biontech.com ↗
showed antitumor activity and a favorable safety profile |
| 2024-08-19 | BioNTech SE | Regulatory Lift of Partial Clinical Hold for BNT326/YL202 biontech.com ↗
On August 15, 2024, the U.S. Food and Drug Administration (“FDA”) lifted the partial clinical hold that was placed on MediLink Therapeutics’ (Suzhou) Co., Ltd. (“MediLink”) Phase I trial evaluating BNT326/YL202 ( NCT05653752 ), which was announced on June 17, 2024. |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-03-24 | BioNTech SE | BioNTech Clinical Data at ELCC 2026 Highlight Potential of Differentiated Late-Stage Portfolio in Lung Cancer biontech.com ↗ |
| 2024-08-19 | BioNTech SE | Lift of Partial Clinical Hold for BNT326/YL202 biontech.com ↗ |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | BNT326 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07070232 ↗ |
| Route | Intravenous | “Intravenous (IV) infusion” NCT07070232 ↗ |