Swedish biotechnology company Alligator Bioscience AB (STO:ATORX) announced on Friday that the US Food and Drug Administration (FDA) has endorsed the 900 µg/kg dose of mitazalimab for its upcoming Phase 3 trial targeting metastatic pancreatic ductal adenocarcinoma (mPDAC).

This regulatory feedback affirms the company's dose selection strategy and marks a significant milestone in the clinical development of its CD40 agonist.

According to CEO Søren Bregenholt, the response from the FDA was both timely and constructive.

The company emphasised the importance of this step as it advances its Phase 3 programme in one of the most challenging oncology indications.

Alligator Bioscience is currently engaged in active discussions with potential partners to support the advancement of mitazalimab into late-stage clinical testing.

The planned Phase 3 study represents the next step in the company's strategy to address unmet medical needs in pancreatic cancer.