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BioNTech (BNTX) FDA Events

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FDA Events for BioNTech (BNTX)

This section highlights FDA-related milestones and regulatory updates for drugs developed by BioNTech (BNTX). Over the past two years, BioNTech has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as BNT111, BNT165e, BNT211, BNT326/YL202, BNT327, COMIRNATY®, and DB-1311. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

BioNTech's Drugs in FDA Review

BNT111 + Libtayo (cemiplimab) - FDA Regulatory Timeline and Events

BNT111 + Libtayo (cemiplimab) is a drug developed by BioNTech for the following indication: Anti-PD1-refractory/relapsed unresectable Stage III or IV melanoma. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

BNT165e - FDA Regulatory Timeline and Events

BNT165e is a drug developed by BioNTech for the following indication: for prevention of P. falciparum malaria in healthy malaria-naive adults. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

BNT211 - FDA Regulatory Timeline and Events

BNT211 is a drug developed by BioNTech for the following indication: For treatment of Advanced Solid Tumors. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

BNT326/YL202 - FDA Regulatory Timeline and Events

BNT326/YL202 is a drug developed by BioNTech for the following indication: For Heavily Pre-Treated Advanced Or Metastatic EGFR-Mutated Non-small Cell Lung Cancer Or HR+/HER2-Negative Breast Cancer. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

BNT327 - FDA Regulatory Timeline and Events

BNT327 is a drug developed by BioNTech for the following indication: In small-cell lung cancer and in triple-negative breast cancer. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

COMIRNATY® JN.1 - FDA Regulatory Timeline and Events

COMIRNATY® JN.1 is a drug developed by BioNTech for the following indication: monovalent COVID-19 vaccine. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

DB-1311 - FDA Regulatory Timeline and Events

DB-1311 is a drug developed by BioNTech for the following indication: For the treatment of patients with advanced/unresectabl. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

mRNA vaccine - FDA Regulatory Timeline and Events

mRNA vaccine is a drug developed by BioNTech for the following indication: Against influenza and COVID-19 in healthy individuals 18-64 years of age. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Omicron KP.2 - FDA Regulatory Timeline and Events

Omicron KP.2 is a drug developed by BioNTech for the following indication: For Omicron KP.2-adapted COVID-19 Vaccine. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

BioNTech FDA Events - Frequently Asked Questions

However, the company does has had drugs under review or in active clinical development.

In the past two years, BioNTech (BNTX) has reported FDA regulatory activity for the following drugs: BNT327, BNT326/YL202, BNT165e, BNT211, Omicron KP.2, mRNA vaccine, BNT111 + Libtayo (cemiplimab), COMIRNATY® JN.1 and DB-1311.

The most recent FDA-related event for BioNTech occurred on June 2, 2025, involving BNT327. The update was categorized as "Provided Update," with the company reporting: "BioNTech and Bristol Myers Squibb announced that the companies have entered into an agreement for the global co-development and co-commercialization of BioNTech's investigational bispecific antibody BNT327 across numerous solid tumor types."

Current therapies from BioNTech in review with the FDA target conditions such as:

  • In small-cell lung cancer and in triple-negative breast cancer - BNT327
  • For Heavily Pre-Treated Advanced Or Metastatic EGFR-Mutated Non-small Cell Lung Cancer Or HR+/HER2-Negative Breast Cancer - BNT326/YL202
  • for prevention of P. falciparum malaria in healthy malaria-naive adults. - BNT165e
  • For treatment of Advanced Solid Tumors - BNT211
  • For Omicron KP.2-adapted COVID-19 Vaccine - Omicron KP.2
  • Against influenza and COVID-19 in healthy individuals 18-64 years of age. - mRNA vaccine
  • Anti-PD1-refractory/relapsed unresectable Stage III or IV melanoma - BNT111 + Libtayo (cemiplimab)
  • monovalent COVID-19 vaccine - COMIRNATY® JN.1
  • For the treatment of patients with advanced/unresectabl - DB-1311

More FDA Event Resources from MarketBeat

  • NDA: New Drug Application
  • ANDA: Abbreviated New Drug Application
  • sNDA: Supplemental New Drug Application
  • BLA: Biologics License Application
  • sBLA: Supplemental Biologics License Application
  • FDA Approved: Approved by the FDA
  • EMA: European Medicines Agency
  • CE Mark: European Union Certification
  • NMPA: China National Medical Products Administration
  • MHLW: Japanese Ministry of Health
  • FDA Meeting: Consultation with FDA
  • Pre-IND: Pre-Investigational New Drug Meeting
  • Breakthrough Therapy: Special FDA designation for promising therapies
  • Fast Track: Accelerated FDA approval pathway
  • Orphan Drug: Designation for rare disease treatments
  • RPD: Rare Pediatric Disease Designation
  • RMAT: Regenerative Medicine Advanced Therapy
  • DSMB Review: Data Safety Monitoring Board Review
  • IDMC Review: Independent Data Monitoring Committee
  • MAA: MHRA Marketing Authorization Application
  • RTF: Refusal to File (Rejected Application)
  • 510(k): FDA Clearance for Medical Devices
  • Rolling Submission: Staggered regulatory review process

This page (NASDAQ:BNTX) was last updated on 7/10/2025 by MarketBeat.com Staff
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