DURECT Corporation Reports Fourth Quarter and Full Year 2022 Financial Results and AHFIRM Trial Update.

CUPERTINO, Calif: DURECT Corporation (Nasdaq: DRRX) today announced financial results for the three months and year ended December 31, 2022 and provided a corporate update.

"We are poised to complete enrollment in our potentially pivotal AHFIRM trial in the second quarter of 2023 and report topline data in the second half of 2023. If the AHFIRM trial outcome is positive, we intend to have discussions with the FDA and other regulatory authorities regarding a possible NDA filing," stated James E. Brown, D.V.M., President and CEO of DURECT. "Larsucosterol has the potential to be the first FDA-approved treatment for alcohol-associated hepatitis, representing a significant step forward in treating patients afflicted with this highly lethal condition."

AHFIRM Trial Update:

DURECT has enrolled more than 260 patients in the AHFIRM trial to date, which exceeds 85% of the target enrollment for the 300-patient trial. We have over 60 AHFIRM study sites open at leading hospitals in the U.S., Australia, E.U. and U.K., including prominent transplant centers. We continue to expect to complete enrollment in the AHFIRM trial in the second quarter of 2023, which should enable topline data to be reported in the second half of 2023.

Financial Highlights for Q4 and Full Year 2022:

Total revenues were $3.3 million and...

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