HC Wainwright invests in stock despite FDA breakthrough drug designation

Wednesday, duret co. (Nasdaq: ) maintains a Neutral stock rating despite the recent announcement by the U.S. Food and Drug Administration (FDA) that it has granted Breakthrough Therapy Designation (BTD) to its drug candidate larsucosterol for the treatment of severe alcohol-related hepatitis (AH). . BTD is supported by results from the Phase 2b AHFIRM study.

The AHFIRM study, which first reported its results in November 2023, did not demonstrate statistical significance for larsucosterol at either dose level in the primary and key secondary endpoints across the entire study population.

However, a more focused analysis of a subset of patients from the United States (76% of participants) showed a significant reduction in mortality at 90 days.

Compared with standard treatment, mortality was reduced by 57% in the 30 mg group and 58% in the 90 mg group, with p-values ​​of 0.014 and 0.008, respectively.

The biopharmaceutical company expects to present a more comprehensive efficacy data set from the AHFIRM trial at the 2024 European Association for the Study of the Liver (EASL) Congress.

The event is scheduled to be held in Milan, Italy, from June 5 to 8, 2024. The presentation, titled “Results from the Phase 2b multicenter randomized trial of larsucosterol in severe alcohol-related hepatitis (AHFIRM trial),” is expected to provide further insight into the drug's performance.

Investors and analysts are anticipating details from the upcoming Phase 3 trial of larsucosterol, which will incorporate feedback from a Type C meeting with the FDA.

The trial is considered the next important milestone for Durect as it moves the drug candidate toward potential commercialization.

The results of the trial could have important implications for the company's future prospects and stock performance.

Investment Professional Insights

As Duret Corp (NASDAQ: DRRX ) prepares for the next phase of development of larsucosterol, new data from InvestingPro sheds light on the company's complex financial situation. Durect has a market capitalization of $40.04 million and has a one-year total price return of -80.0%, but its shares have experienced significant volatility. Nonetheless, the company's short-term returns remain strong, with a one-week total price return of 34.38% and a one-month total price return of 60.25%.

InvestingPro Tips highlighted last week's high shareholder yields and significant returns, suggesting a possible rebound in investor confidence following the BTD announcement. However, analysts warn that Durect is burning through cash quickly and has weak gross margins, as evidenced by its -272.18% gross margin for the trailing 12 months to Q1 2024. complex.

Investors considering Durette's prospects may find these insights valuable when evaluating the stock's potential. For those looking for more analysis and tips, Durect Corp also offers 10 additional InvestingPro tips at https://www.investing.com/pro/DRRX. Additionally, readers can also use coupon codes PRONEWS24 Annual or biennial Pro and Pro+ subscriptions receive an additional 10% discount, providing more comprehensive investment analysis tools.

This article was generated with the support of artificial intelligence and reviewed by an editor. For more information, please see our terms and conditions.

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