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
BNT316/ONC-392, BNT327, BNT165e, BNT211, and Omicron. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
BNT316/ONC-392 (gotistobart) FDA Regulatory Events
BNT316/ONC-392 (gotistobart) is a drug developed by BioNTech for the following indication: Combination therapy in various cancer indications.
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.
- Drug:
- BNT316/ONC-392 (gotistobart)
- Announced Date:
- August 20, 2026
- Indication:
- Combination therapy in various cancer indications.
Announcement
BioNTech SE will present new clinical data from its diversified development program in lung cancer treatment at the IASLC 2026 World Conference on Lung Cancer ("WCLC") in Seoul, Republic of Korea, from September 12-15, 2026.
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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.
- Drug:
- BNT327
- Announced Date:
- December 9, 2025
- Indication:
- In small-cell lung cancer and in triple-negative breast cancer
Announcement
BioNTech SE and announced the first interim data from a global randomized Phase 2 trial (NCT06449222) evaluating pumitamig (BNT327/BMS986545), an investigational bispecific antibody targeting PD-L1 and VEGF-A, plus chemotherapy in patients with locally advanced/metastatic triple-negative breast cancer ("TNBC") irrespective of PD-L1 expression levels. Bristol Myers Squibb Company
AI Summary
BioNTech and Bristol Myers Squibb reported interim results from a global Phase 2 trial of pumitamig (BNT327/BMS986545), a bispecific antibody that targets PD-L1 and VEGF‑A, given with chemotherapy for locally advanced or metastatic triple‑negative breast cancer (TNBC) regardless of PD‑L1 status. Among 39 efficacy‑evaluable first‑ and second‑line patients in Cohort 1, confirmed objective response rate (cORR) was 61.5%, unconfirmed ORR (uORR) was 71.8%, and disease control rate (DCR) was 92.3%. Responses were seen across PD‑L1 levels and lines of therapy; higher dose (20 mg/kg) showed greater response than 15 mg/kg (uORR 80.0% vs 63.2%). The 9‑month progression‑free survival rate was 59.3%.
The combination had a manageable safety profile across chemotherapy regimens. Grade ≥3 treatment‑related adverse events occurred in about 38–43% of patients, with no pumitamig‑related deaths. These data support ongoing development, including dose selection for the pivotal Phase 3 ROSETTA BREAST‑01 trial, and will be presented at SABCS 2025.
Read Announcement- Drug:
- BNT327
- Announced Date:
- June 2, 2025
- Indication:
- In small-cell lung cancer and in triple-negative breast cancer
Announcement
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.
AI Summary
BioNTech and Bristol Myers Squibb have announced a global partnership to co-develop and co-commercialize BioNTech’s investigational bispecific antibody BNT327 for various solid tumor types. BNT327, which targets both PD-L1 and VEGF-A, is designed to boost the immune system’s ability to fight cancer while also hindering tumor blood vessel growth. The companies will share profits and losses equally and combine their expertise and resources to accelerate the clinical development and potential regulatory approvals of this innovative therapy. With over 1,000 patients already treated across several trials, BNT327 is currently being evaluated as a standalone treatment and in combination with other therapies. This strategic collaboration aims to expand treatment options and potentially set a new standard of care in oncology by addressing a broad range of solid tumors.
Read Announcement- Drug:
- BNT327
- Announced Date:
- April 24, 2025
- Indication:
- In small-cell lung cancer and in triple-negative breast cancer
Announcement
BioNTech SE announced that it will present data for selected assets from its diversified oncology pipeline, including mRNA cancer immunotherapies, next-generation immunomodulators, and targeted therapies, at the American Association for Cancer Research ("AACR") Annual Meeting held in Chicago, Illinois from April 25-30, 2025.
AI Summary
BioNTech SE announced plans to present select data from its diversified oncology pipeline at the AACR Annual Meeting in Chicago from April 25‑30, 2025. The company will highlight advances in mRNA cancer immunotherapies, next‑generation immunomodulators, and targeted therapies. A key focus will be on early data for combining its PD‑L1xVEGF‑A bispecific antibody candidate with antibody‑drug conjugates (ADCs) to enhance antitumor effects.
Prof. Özlem Türeci, Co‑Founder and Chief Medical Officer, emphasized that combining novel immuno‑oncology approaches could set a future standard for advanced cancer treatment. The data presentations are designed to showcase BioNTech’s strategy of integrating complementary mechanisms to drive synergistic antitumor activity and improve patient outcomes, marking another significant step in the company’s efforts to innovate within the oncology field.
Read Announcement- Drug:
- BNT327
- Announced Date:
- March 10, 2025
- Indication:
- In small-cell lung cancer and in triple-negative breast cancer
Announcement
BioNTech SE provided an update on its corporate progress.
AI Summary
BioNTech SE provided a corporate progress update focusing on its expanding oncology pipeline. The company has strengthened its development of next-generation immunomodulators with candidate BNT327, a bispecific antibody that targets PD-L1 and VEGF-A. With the completion of its acquisition of Biotheus, BioNTech secured full control of BNT327 and related assets, setting the stage for several ongoing Phase 2 and Phase 3 clinical trials in various cancers such as small cell lung cancer, non-small cell lung cancer, and triple-negative breast cancer.
Looking ahead, BioNTech expects key data readouts in 2025 and 2026 that could provide clinical proof for its oncology strategy, aiming to become a diversified multi-product oncology portfolio company by 2030. The company’s strong financial position and significant R&D investments further support its long-term vision for transforming cancer treatment.
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BNT165e FDA Regulatory 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.
- Drug:
- BNT165e
- Announced Date:
- March 5, 2025
- Indication:
- for prevention of P. falciparum malaria in healthy malaria-naive adults.
Announcement
BioNTech announced that The U.S. Food and Drug Administration (“FDA”) has informed BioNTech SE (“BioNTech”) that it has placed a clinical hold on BioNTech’s Investigational New Drug application (“IND”) and the related Phase I/IIa clinical trial (NCT06069544) evaluating the safety, tolerability, immunogenicity and efficacy of an investigational RNA-based vaccine (BNT165e) for prevention of P. falciparum malaria in healthy malaria-naive adults.
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BNT211 FDA Regulatory 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.
- Drug:
- BNT211
- Announced Date:
- September 5, 2024
- Indication:
- For treatment of Advanced Solid Tumors
Announcement
BioNTech SE will present clinical trial data for selected assets from its multi-platform oncology pipeline at the European Society for Molecular Oncology ("ESMO") Congress 2024 in Barcelona, Spain from September 13-17, 2024.
AI Summary
BioNTech SE will showcase clinical trial data from its multi-platform oncology pipeline at the ESMO Congress 2024 in Barcelona, Spain, taking place from September 13–17, 2024. The presentations will include both oral and poster sessions that highlight new progress in mRNA-based cancer vaccines, next-generation immunomodulators, and targeted therapy approaches. Prof. Özlem Türeci, Co-Founder and Chief Medical Officer at BioNTech, emphasized the potential of combining treatment modalities to improve cancer care. At the congress, the company will detail findings from three clinical trials focusing on BNT327/PM8002, a bispecific antibody that forms a key component of their combination treatment strategy. Additional clinical data will support the proof of concept of BioNTech’s mRNA-based FixVac approach, which targets non-mutated tumor-associated antigens and has shown early signs of clinical activity for various cancer indications.
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Omicron KP.2 FDA Regulatory 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.
- Drug:
- Omicron KP.2
- Announced Date:
- August 22, 2024
- Indication:
- For Omicron KP.2-adapted COVID-19 Vaccine
Announcement
Pfizer Inc. and BioNTech SE announced that the U.S. Food and Drug Administration ("FDA") has approved the supplemental Biologics License Application for individuals 12 years of age and older (COMIRNATY® (COVID-19 Vaccine, mRNA)), and granted emergency use authorization for individuals 6 months through 11 years of age (Pfizer-BioNTech COVID-19 Vaccine) of the companies' Omicron KP.2-adapted 2024-2025 Formula COVID-19 vaccine.
AI Summary
Pfizer Inc. and BioNTech SE announced that the FDA has approved the supplemental Biologics License Application for COMIRNATY® (COVID-19 Vaccine, mRNA) for individuals 12 years and older. The FDA also granted emergency use authorization for the Pfizer-BioNTech COVID-19 Vaccine for children 6 months to 11 years old. This updated vaccine is designed to protect against the Omicron KP.2 strain and is the preferred approach for the 2024-2025 fall and winter season, following FDA guidance. For most people 5 years and older, the vaccine is administered as a single dose. The decision is backed by extensive clinical, non-clinical, and real-world evidence showing that the updated formulation elicits a strong immune response and improved protection against emerging strains. Shipping has already begun to ensure widespread availability in pharmacies, hospitals, and clinics nationwide.
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