The efforts add up to a new trend after Chinese pharma firms embarked on a quest to launch pivotal Phase II or III trials worldwide, especially in the US and Europe, over the past decade. Meanwhile, BeiGene, Hengrui and others are advancing late-stage programs in the US.

Principal deputy commissioner Bumpus agrees with advisory committee findings that safety issues with ITCA 650 preclude approval, regardless of comparisons to other diabetes treatments. Final order caps a nearly eight-year regulatory saga that has grown increasingly rancorous.

The biotech plans a pivotal trial that would support accelerated approval of the Takeda-partnered antisense oligonucleotide, WVE-003, and will discuss it with regulators before the end of the year.

The biotech said it plans to engage with regulators before the end of the year for the Takeda-partnered antisense oligonucleotide, WVE-003, to discuss a pivotal trial that would support accelerated approval.