Durect (DRRX)

[MythicSphinx35]

FDA Update & Key Points:

“We are pleased that the feedback from the U.S. Food and Drug Administration (FDA) supports the advancement of larsucosterol into a single pivotal Phase 3 clinical trial"

"if successful, may serve as the basis for a New Drug Application (NDA) in alcohol-associated hepatitis (AH),” stated James E. Brown, D.V.M., President and CEO of DURECT.

“We are in the process of designing the registrational Phase 3 trial incorporating the FDA’s comments and insights gained from our Phase 2b AHFIRM trial."

"We expect to provide additional details on our planned Phase 3 protocol and present new analyses from AHFIRM later in the year.”

"During a Type C meeting with the FDA, DURECT received feedback on the recommendations for a Phase 3 clinical trial for larsucosterol in AH that could support a potential NDA filing. DURECT is in the process of designing its planned Phase 3 clinical trial based on the FDA feedback and the results from its completed Phase 2b AHFIRM clinical trial."