89Bio Q3 2023 Earnings Report
Key Takeaways
89bio reported a net loss of $34.7 million for the third quarter ended September 30, 2023. As of September 30, 2023, the company's cash, cash equivalents and short-term available-for-sale securities totaled $448.3 million. The FDA granted Breakthrough Therapy Designation to pegozafermin for NASH with fibrosis.
FDA granted Breakthrough Therapy Designation to pegozafermin for the treatment of NASH with fibrosis.
Data from ENLIVEN trial of patients with F4 NASH will be featured in an oral presentation during AASLD The Liver Meeting.
Company expects to receive feedback from regulatory agencies on the pegozafermin Phase 3 NASH development program this quarter.
Enrollment continues to progress in ENTRUST, the Phase 3 trial evaluating pegozafermin in patients with SHTG.
89Bio
89Bio
Forward Guidance
The company expects to initiate its Phase 3 program in NASH in the first half of 2024. Topline results from ENTRUST trial are expected in 2025.