Posted by Michael Wonder on 03 Jun 2026
Terremoto Biosciences granted FDA fast track designation for TER-2013, an AKT1 selective small molecule inhibitor for breast cancer
3 June 2026 - Terremoto Biosciences today announced that the US FDA granted fast track designation for TER-2013, the Company’s lead AKT1 selective inhibitor, in patients with locally advanced, unresectable or metastatic HR+/HER2- breast cancer harbouring one or more AKT/PI3K/PTEN alterations following progression on at least one endocrine-based therapy and CDK4/6 inhibitor for advanced disease.
TER-2013 is an investigational, orally bioavailable small-molecule inhibitor designed to selectively target AKT1, maximising target engagement within tumour cells.
