Why Albireo Pharma (ALBO) Shares Are Trading Higher Today

Albireo Pharma Inc ALBO announced topline results from the Phase 3 ASSERT study evaluating the safety and efficacy of Bylvay in Alagille syndrome (ALGS) patients from birth to early adulthood.
The trial met its primary endpoint of improvement in pruritus and its key secondary endpoint of reduction in serum bile acids.
Statistically significant improvements in multiple sleep parameters were observed as early as week 1-4 compared to patients on placebo, with continued improvement through week 24.
Bylvay (odevixibat) is the first drug approved in the U.S. for pruritus in patients three months and older in all progressive familial intrahepatic cholestasis.
There were no patient discontinuations, and Bylvay was well tolerated, with low rates of drug-related diarrhea (11.4% vs. 5.9% placebo).
The company continues to enroll patients in the Phase 3 BOLD study in biliary atresia. Enrollment is expected to conclude by the end of this year. Topline data is planned for 2024.
Albireo has engaged in discussions with the FDA and European Medicines Agency about the Phase 3 study design. Both have indicated that a successful single study would be sufficient for approval. The company plans to submit regulatory filings in the U.S. and EU immediately.
Price Action: ALBO shares are up 7.96% at $22.10 on the last check Tuesday.

Why Are Albireo Pharma Shares Gaining Today?