BridgeBio stock rises as BBP-398, Lumakras combo for lung cancer gets FDA fast track status
Iryna Drozd


BridgeBio Pharma (NASDAQ:BBIO) stock rose ~4% on Oct. 11 after the company said the U.S. Food and Drug Administration (FDA) granted fast track designation to BBP-398 in combination with Amgen's (NASDAQ:AMGN) Lumakras for adult patients with previously treated, KRAS G12C-mutated, metastatic non-small cell lung cancer (NSCLC).

BridgeBio has a license agreement with Bristol Myers Squibb (BMY) to develop and commercialize BBP-398 in oncology globally, except for mainland China and other Asian markets as these are part of a separate agreement with LianBio (LIAN), the company noted.
In addition, BridgeBio said that the first patient with NSCLC was dosed in a phase 1/2 trial of BBP-398 with Lumakras (sotorasib).
The dose escalation part will enroll patients with all solid tumors with a KRAS G12C mutation and people will be eligible regardless of previous therapy with a KRAS G12C inhibitor. The dose expansion period will enroll patients with NSCLC with a KRAS G12C mutation who have not previously been exposed to a KRAS G12C inhibitor, the company added.
BridgeBio expects initial data by the end of 2024.