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DURECT (Nasdaq: DRRX) has received Breakthrough Therapy designation (BTD) from the FDA for larsucosterol, aimed at treating severe alcohol-associated hepatitis (AH). AH has no approved treatments and high mortality rates, making the designation crucial. The decision is backed by positive results from the Phase 2b AHFIRM trial. DURECT plans to initiate a Phase 3 clinical trial to confirm the efficacy and safety of larsucosterol. Detailed results will be presented at the EASL Congress 2024 in Milan on June 8, 2024.
DURECT (Nasdaq: DRRX) announced its Q1 2024 financial results, showing $1.8 million in revenue and a net loss of $7.6 million, an improvement from the $12.0 million loss in Q1 2023. The company has $21.6 million in cash and investments, with a debt of $14.6 million as of March 31, 2024. The FDA's feedback supports a single pivotal Phase 3 trial for larsucosterol in alcohol-associated hepatitis (AH), with new Phase 3 protocol details expected later this year. DURECT will present Phase 2b AHFIRM trial data at the EASL Congress in June 2024. A webcast of the earnings call will be held today at 4:30 p.m. ET.
DURECT (Nasdaq: DRRX) will report its first quarter 2024 financial results on May 13, 2024. The company focuses on epigenetic therapies for severe conditions like organ injury and cancer. A conference call and webcast will follow to discuss the results and provide a corporate update.
DURECT (Nasdaq: DRRX) announced a late-breaking oral presentation at the EASL Congress 2024 to discuss data from the Phase 2b AHFIRM trial on larsucosterol for severe alcohol-associated hepatitis. The presentation will be held on June 8, 2024, in Milan, Italy.