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, COMIRNATY®, BNT327, and BNT165e. 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:
- September 14, 2026
- Indication:
- Combination therapy in various cancer indications.
Announcement
BioNTech SE announced the first median overall survival ("OS") data from the non-pivotal stage 1 of the global randomized PRESERVE-003 Phase 3 clinical trial (NCT05671510) of gotistobart (also known as BNT316 or ONC-392), in patients with squamous non-small lung cancer ("NSCLC") whose disease progressed on prior immunotherapy and chemotherapy.
Read Announcement- 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.
Read Announcement
COMIRNATY® XFG; COVID-19 Vaccine, mRNA FDA Regulatory Events
COMIRNATY® XFG; COVID-19 Vaccine, mRNA is a drug developed by BioNTech for the following indication: COVID-19.
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:
- COMIRNATY® XFG; COVID-19 Vaccine, mRNA
- Announced Date:
- August 27, 2026
- Indication:
- COVID-19
Announcement
Pfizer Inc and BioNTech SE announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for the companies’ 2026-2027 COVID-19 vaccine formula targeting the XFG variant (COMIRNATY® XFG; COVID-19 Vaccine, mRNA) for use in adults ages 65 years and older, as well as in individuals ages 5 through 64 years with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.1
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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.
Read Announcement
