Inhibrx's Experimental Drug For Inherited Disease Capable For Accelerated FDA Approval, Shares Surge

Based on discussions with the FDA, Inhibrx Inc INBX has the potential to pursue accelerated approval for INBRX-101 for emphysema due to alpha-1 antitrypsin deficiency (AATD) using functional alpha-1 antitrypsin (AAT) serum levels as the surrogate endpoint.
Inhibrx also detected INBRX-101 in the bronchoalveolar lavage fluid (BALF) samples from all AATD patients tested in the Phase 1 study.
Related: Inhibrx's INBRX-101 Shows Favorable Safety Profile In An Inherited Disorder.
Inhibrx plans to initiate in Q1 of 2023 a potential registration-enabling trial using functional AAT as a surrogate endpoint.
Based on data from the completed Phase 1 study, INBRX-101 is predicted to maintain patients above the lower threshold of the normal range and achieve an average level of functional AAT.
The FDA also requested additional data on the correlation between functional AAT levels and the clinical benefit of AATD to further support serum AAT levels as a surrogate endpoint that is reasonably likely to predict clinical benefit.
Price Action: INBX shares are up 30.9% at $26.41 during the premarket session on the last check Tuesday.