DURECT Corp. is a biopharmaceutical company focused on two areas of active drug development: New therapeutics based on its proprietary drug delivery platforms and new chemical entities derived from its epigenomic regulator program. Its drug development expertise is being applied primarily to the fields of pain management, central nervous system disorders, acute organ injury and metabolic diseases such as nonalcoholic fatty liver disease/nonalcoholic steatohepatitis. Late-stage development programs include POSIMIR (SABER-bupivacaine) and REMOXY (ORADUR-oxycodone). DURECT's epigenomic regulator program includes the lead molecule DUR-928 in Phase 1 development. DUR-928 is an endogenous small molecule that modulates lipid homeostasis, inflammation and cell survival.

Expert Comments:

Mayank Mamtani, B. Riley FBR Inc.

"The final patient of DURECT Corp.'s Phase 1b nonalcoholic steatohepatitis trial is scheduled to begin the 28-day dosing period next week. All patients are expected to conclude dosing and follow-up visits in Q2/20, with topline data anticipated shortly thereafter. . .the company's stock presents an additional attractive entry point."

Francois Brisebois, Craig-Hallum Capital

"We were particularly encouraged to learn that DURECT Corp.'s DUR-928 for alcoholic hepatitis remains on track as the company continues to expect initiation of its potentially pivotal Phase 2b in mid-2020. . .the company reported having already exceeded its enrollment target of 60 patients in its Phase 1b repeat administration nonalcoholic steatohepatitis trial. . .DUR-928 remains the main reason to own DURECT."

Adam Walsh, Stifel

"DURECT Corp. is working with the U.S. Food and Drug Administration to finalize the Phase 2b design in alcoholic hepatitis (AH), and it plans to initiate the trial in mid-2020. . .topline data are estimated in FY22. The AH program holds promise based on the well-received Phase 2a data."

Eliana Merle, Cantor Fitzgerald

"An approval of DURECT Corp.'s Posimir would be a significant upside driver for shares. . .from a stock perspective, we see favorable risk/reward. . .we see potential of about 50–100% upside on an approval (company has said it would outlicense Posimir if approved)."

headshot of Ed Arce

Ed Arce, H.C. Wainwright & Co.

"DURECT Corp.'s Phase 2b DUR-928 alcoholic hepatitis trial is set to begin in mid-2020; the company announced plans for a new Phase 2b trial that we expect to enroll approximately 150 patients, who are randomized to be treated with DUR-928 in one of two active dosages (30 mg or 90 mg) or placebo. . .data from the Phase 1b nonalcoholic steatohepatitis trial is on schedule for a mid-2020 readout. . .the last patient is scheduled to begin the 28-day dosing period next week."

The company, however, will continue to advance the same therapeutic in two other diseases.
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Ed Arce, H.C. Wainwright & Co.

"From a stock perspective, 2019 was a clear breakout year for DURECT Corp., which closed at $3.80/share, gaining +692% (versus the NASDAQ Biotechnology Index + 24.4%). However, even more intriguing to us is that the shares gained just over half of their year-end value in the last two weeks of 2019 (from the $1.88 close on Dec. 16); importantly, though, we believe this recent spike in the shares, which added $369M in market value, was all about the company's alcoholic hepatitis program."

The online presentation coincides with The Liver Meeting 2019, at which data also are shared.
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Data from this study should be released by the end of this year.
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More Expert Comments

Experts Following This Company

headshot of Ed Arce
Ed Arce, Managing Direction and Senior Research Analyst – H.C. Wainwright & Co.
Francois Brisebois, Senior Research Analyst – Craig-Hallum Capital
Mayank Mamtani, Analyst – B. Riley FBR Inc.
headshot of Brian Marckx
Brian Marckx, CFA – Zacks Small-Cap Research
Eliana Merle, Research Analyst – Cantor Fitzgerald
Adam Walsh, Analyst-Healthcare – Stifel

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Investing Highlights
DUR-928, in Phase 1, is an Endogenous Small Molecule with Compelling Animal Data
Two Late Stage Pain Products Addressing Large Markets
Company Holds the WW Rights to DUR-928 and POSIMIR