Durect reports Q2 EPS (12c), consensus (17c)

Reports Q2 revenue $2.17M, consensus $2.49M. “Our immediate priority is to finalize the design of our planned pivotal Phase 3 trial of larsucosterol in alcohol-associated hepatitis,” stated James Brown, D.V.M., President and CEO of DURECT. “Recently we had a productive Type B meeting with the U.S. Food and Drug Administration to discuss our proposed trial design and requirements to obtain approval. We are encouraged by the FDA’s feedback on our plans to advance development of larsucosterol, including its granting of Breakthrough Therapy Designation (BTD), and look forward to providing a further update on specifics of the Phase 3 design following expected communications from FDA. Assuming we obtain sufficient funds, we plan to initiate the Phase 3 study by the end of 2024 and would expect to report topline results by the second half of 2026. We are committed to advancing development of larsucosterol and bringing this potentially lifesaving therapy to patients as quickly as possible. If larsucosterol meets our expectations in Phase 3 and we are successful in gaining approval, it would likely be the first FDA-approved treatment for AH.”