DRRX:NASDAQ

DURECT Corp.

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.
DRRX:NASDAQ

Expert Comments:

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

(1/3/20)
"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."

Ed Arce, H.C. Wainwright & Co.

(11/25/19)
"Strong evidence of DURECT Corp.'s DUR-928 in alcohol hepatitis (AH) is the reduction in bilirubin (the hallmark of disease) within the first week, the dramatic reductions in Lille scores and the high discharge rate in four days even for severe AH patients, shown in the Phase 2a trial. With no current treatments (steroids have no impact on outcomes) and nothing else in development for AH, we believe the company has a valuable greenfield opportunity here with DUR-928."

Ed Arce, H.C. Wainwright & Co.

(11/20/19)
"An Advisory Committee meeting for DURECT Corp.'s POSIMIR is formally scheduled for Jan. 16, 2020. . .we continue to expect Food and Drug Administration approval of POSIMIR based on the existing safety and efficacy data portfolio from a number of completed trials."

The online presentation coincides with The Liver Meeting 2019, at which data also are shared.
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Ed Arce, H.C. Wainwright & Co.

(11/3/19)
"DURECT Corp. has enrolled over half of the expected patients in a Phase 1b randomized and open-label clinical study being conducted in the U.S. to evaluate safety, pharmacokinetics and signals of biological activity of DUR-928 in nonalcoholic steatohepatitis patients with stage 1 to 3 fibrosis. . .the company's psoriasis trial is on target for topline data by year-end 2019."

Data from this study should be released by the end of this year.
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These results are from the recently completed clinical trial of the firm's lead drug candidate.
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Francois Brisebois, Laidlaw & Company

(9/18/19)
"DURECT Corp. recently announced Phase 2a data from its main value driver DUR-928 in alcoholic hepatitis (AH). . .with statistically significant efficacy data in AH (high unmet medical need) and a clean safety profile, we look forward to more color at the annual American Association of the Study of Liver Diseases meeting in Boston (Nov. 9 to 12)."

headshot of Ed Arce

Ed Arce, H.C. Wainwright & Co.

(9/18/19)
"DURECT Corp.'s DUR-928 treatment led to improved disease prognosis in alcoholic hepatitis (AH) patients. Yesterday, the company reported that statistically significantly lower Lille scores plus statistically significantly greater reductions of bilirubin (days 7 and 28) and MELD scores (day 28) from baseline were observed in 19 AH patients treated with DUR-928, when compared to a historical control group from a University of Louisville study of 15 AH patients who received either supportive care alone (n=8) or supportive care with corticosteroids (n=7)."

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, Healthcare Research Analyst – Laidlaw & Company
Patrick Dolezal – LifeSci Capital
headshot of Brian Marckx
Brian Marckx, CFA – Zacks Small-Cap Research

The information provided above is from analysts, newsletters, the company and other contributors.

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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