Biotech Values

[biocqr]

ZFGN > Leerink comments:

As we previously highlighted in detail, preclinical data suggests that ZGN-1061 has the potential to induce clotting factors if it is not cleared. Despite a clean safety report card to date in a small Ph.2 study, our main concerns have stemmed from lack of disclosure about how the drug is metabolized and cleared, and the potential for drug-drug interactions that could delay the drug’s clearance when tested in a larger Ph.3 study of T2D patients, which we believe could have played into the FDA’s decision. How this decision will affect the overall timeline for this program is unknown, but the company plans on defining a path forward with regulators.