Enrollment of 300 patients is now done for the Phase 2b AHFIRM study of DURECT Corp.'s (DRRX:NASDAQ) larsucosterol in severe alcohol-associated hepatitis, and if results are "strikingly positive" like the Phase 2a data, they could support a new drug application for this compound, reported H.C. Wainwright & Co. analyst Ed Arce in a June 7 research note.
"We regard AHFIRM's topline data readout in Q4/23 as the key clinical milestone for larsucosterol and a potentially transformational catalyst for DURECT shares," Arce wrote.
Potential 479% Return
Accordingly, H.C. Wainwright reiterated its Buy rating and US$32 per share target price on California, U.S.-based biopharma, currently trading at about US$5.53 per share.
The difference between the target and current prices represents a material possible gain for investors in DURECT of 479%.
Preparing To Advance Drug
DURECT is getting ready for accelerated discussions with the U.S. Food and Drug Administration (FDA), given larsucosterol's fast track designation.
Also, the biopharma has started planning the commercial launch of this investigative drug in the States.
Multisite, Randomized Trial
Arce described the design of Phase 2b AHFIRM study. It is randomized, double-blind, placebo-controlled, and multisite, being conducted in the U.S., Australia, the United Kingdom, and European Union.
All 300 enrolled patients have severe alcohol-associated hepatitis as indicated by a Maddrey's Discriminant Function score of 32 or higher and a MELD score between 21 and 30.
Patients are being randomized on a 1:1:1 basis to receive, on day one and if still hospitalized, on day one, up to two intravenous doses of either: larsucosterol 30 mg, larsucosterol 90 mg, or placebo plus the standard of care.
The primary efficacy endpoint of the trial measures the 90-day mortality or, as preferred by the FDA, liver transplant in patients who received larsucosterol versus placebo plus standard of care. Secondary endpoints include 28-day survival, frequency of adverse events, scores on prognostic tests like the MELD and the Lille and time required in the intensive care unit.
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Disclosures for H.C.Wainwright & Co., DURECT Corp., June 7, 2023
This material is confidential and intended for use by Institutional Accounts as defined in FINRA Rule 4512(c). It may also be privileged or otherwise protected by work product immunity or other legal rules. If you have received it by mistake, please let us know by e-mail reply to [email protected] and delete it from your system; you may not copy this message or disclose its contents to anyone. The integrity and security of this message cannot be guaranteed on the Internet. H.C. WAINWRIGHT & CO, LLC RATING SYSTEM: H.C. Wainwright employs a three tier rating system for evaluating both the potential return and risk associated with owning common equity shares of rated firms. The expected return of any given equity is measured on a RELATIVE basis of other companies in the same sector. The price objective is calculated to estimate the potential movements in price that a given equity could reach provided certain targets are met over a defined time horizon. Price objectives are subject to external factors including industry events and market volatility.
H.C. Wainwright & Co, LLC (the “Firm”) is a member of FINRA and SIPC and a registered U.S. Broker-Dealer. I, Ed Arce and Thomas Yip , certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies. None of the research analysts or the research analyst’s household has a financial interest in the securities of DURECT Corporation (including, without limitation, any option, right, warrant, future, long or short position).
As of May 31, 2023 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of DURECT Corporation. Neither the research analyst nor the Firm knows or has reason to know of any other material conflict of interest at the time of publication of this research report.
The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services. The firm or its affiliates received compensation from DURECT Corporation for non-investment banking services in the previous 12 months. =
The Firm or its affiliates did not receive compensation from DURECT Corporation for investment banking services within twelve months before, but will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report. The Firm does not make a market in DURECT Corporation as of the date of this research report. The securities of the company discussed in this report may be unsuitable for investors depending on their specific investment objectives and financial position. Past performance is no guarantee of future results. This report is offered for informational purposes only, and does not constitute an offer or solicitation to buy or sell any securities discussed herein in any jurisdiction where such would be prohibited. This research report is not intended to provide tax advice or to be used to provide tax advice to any person. Electronic versions of H.C. Wainwright & Co., LLC research reports are made available to all clients simultaneously.
No part of this report may be reproduced in any form without the expressed permission of H.C. Wainwright & Co., LLC. Additional information available upon request. H.C. Wainwright & Co., LLC does not provide individually tailored investment advice in research reports. This research report is not intended to provide personal investment advice and it does not take into account the specific investment objectives, financial situation and the particular needs of any specific person. Investors should seek financial advice regarding the appropriateness of investing in financial instruments and implementing investment strategies discussed or recommended in this research report. H.C. Wainwright & Co., LLC’s and its affiliates’ salespeople, traders, and other professionals may provide oral or written market commentary or trading strategies that reflect opinions that are contrary to the opinions expressed in this research report. H.C. Wainwright & Co., LLC and its affiliates, officers, directors, and employees, excluding its analysts, will from time to time have long or short positions in, act as principal in, and buy or sell, the securities or derivatives (including options and warrants) thereof of covered companies referred to in this research report. The information contained herein is based on sources which we believe to be reliable but is not guaranteed by us as being accurate and does not purport to be a complete statement or summary of the available data on the company, industry or security discussed in the report. All opinions and estimates included in this report constitute the analyst’s judgment as of the date of this report and are subject to change without notice. Securities and other financial instruments discussed in this research report: may lose value; are not insured by the Federal Deposit Insurance Corporation; and are subject to investment risks, including possible loss of the principal amount invested.
