The trial will include patients with non-small cell lung, breast, ovarian, gastric, esophageal, and colorectal cancers.
With this approval, patients who receive the anti-amyloid drug biweekly for 18 months can then consider switching to a monthly dosing regimen.
The firm said it has received positive feedback from the FDA on the design of a Phase III trial of ELI-002 in KRAS-mutant pancreatic cancer.
Their study showed that DCIS patients with pathogenic variants in BRCA1/2 and PALB2 had a higher risk of developing invasive breast cancer than those without.
The Shanghai-based firm will test the gene therapy candidate in patients between 4 and 9 years old with Duchenne muscular dystrophy.
BH-30643 is an OMNI-EGFR inhibitor that targets classical, atypical, and compound EGFR mutations and acquired resistance mutations in HER2.
The companies will focus on advancing AXV-101, with which they hope to treat retinal dystrophy by targeting mutations in the BBS1 gene.
In a Phase I/II trial, patients with X-linked chronic granulomatous disease will receive a treatment created using a new approach to base editing.