Shots:

• The submission is based on the P-II studies & ongoing P-III MYR301 study to evaluate bulevirtide (2/10mg, qd) in patients with chronic HDV infection
• The interim results from the P-III MYR301 study showed that the proportion of patients achieved virological & biochemical response (36.7%/28%) and 0% in patients under observation who have not received antiviral treatment @ 24wks., Bulevirtide (2mg) had a significant response over no treatment group while ALT reduction & normalization in >50% of people with HDV
• The safety profile was consistent with previously completed studies @24wks., no serious AEs, symptomatic elevations in bile salts or AEs leads to discontinuation were observed

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