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BioNTech SE (BNTX)
NASDAQ:BNTX
Pembrolizumab, Pumitamig
Non-Small Cell Lung Cancer (Nsclc)
Phase III
Not Yet Recruiting
A Study to Evaluate the Efficacy of Pumitamig Versus Pembrolizumab in Participants With Previously Untreated Advanced Non-Small Cell Lung Cancer and PD-L1 ≥ 50%. (ROSETTA Lung-202)
Jan 21, 2026
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Durvalumab, Pumitamig
Non-Small Cell Lung Cancer (Nsclc)
Phase III
Not Yet Recruiting
A Study to Evaluate Pumitamig Versus Durvalumab Following Concurrent Chemoradiation Therapy in Participants With Unresectable Stage III Non-small Cell Lung Cancer (NSCLC) (ROSETTA Lung-201)
Jan 21, 2026
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Atezolizumab, Bevacizumab, Ipilimumab, Pumitamig
Hepatocellular Carcinoma (Hcc)
Phase I/II
Not Yet Recruiting
A Study to Evaluate the Safety and Tolerability of Pumitamig Alone or In Combination With Ipilimumab in Participants With First-Line Advanced or Unresectable Hepatocellular Carcinoma (HCC) (ROSETTA HCC-206)
Dec 17, 2025
Nivolumab, Ipilimumab, Pumitamig, Cabozantinib
Advanced Renal Cell Carcinoma (Rcc)
Phase I/II
Not Yet Recruiting
A Study to Evaluate the Safety, Tolerability, and Efficacy of Pumitamig Alone or in Combination With Ipilimumab or Cabozantinib in Participants With Advanced Renal Cell Carcinoma (RCC) (ROSETTA RCC-208)
Dec 17, 2025
Gemcitabine, Nab-Paclitaxel, Mfolfirinox, Pumitamig
Pancreatic Ductal Adenocarcinoma (Pdac)
Phase II
Recruiting
A Clinical Trial Testing the Safety of BNT327 (an Investigational Drug) and How Well it Works When Combined With Chemotherapy for People Who Have Not Been Treated Yet for Pancreatic Cancer
Nov 20, 2025
Nivolumab, Folfox, Pumitamig, Capox
Untreated Advanced Or Metastatic Gastric, Gastroesophageal Junction, Or Esophageal Adenocarcinoma
Phase II/III
Not Yet Recruiting
A Study to Evaluate the Safety and Efficacy of Pumitamig in Combination With Chemotherapy Versus Nivolumab in Combination With Chemotherapy in Participants With Previously Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma
Oct 23, 2025
Bevacizumab, Folfiri, Folfox, Pumitamig, Capox
Untreated, Unresectable, Or Metastatic Colorectal Cancer
Phase II/III
Recruiting
A Study to Evaluate the Safety and Efficacy of Pumitamig in Combination With Chemotherapy Versus Bevacizumab in Combination With Chemotherapy in Participants With Previously Untreated, Unresectable, or Metastatic Colorectal Cancer
Oct 23, 2025
FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does BioNTech SE (BNTX) have in its pipeline
BNTX is currently developing the following drugs: Pembrolizumab, Pumitamig, Durvalumab, Pumitamig, Atezolizumab, Bevacizumab, Ipilimumab, Pumitamig. These drug candidates are in various stages of clinical development as the company works toward FDA approval.