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:

headshot of Brian Marckx

Brian Marckx, Zacks Small-Cap Research

(5/16/19)
"Preliminary data from DURECT Corp.'s DUR-928 Phase 2a trial in alcoholic hepatitis on the first 10 patients (eight 30 mg: four moderate, four severe, and two 90 mg: one moderate, one severe) was reported on May 7. Results, in our opinion, are highly compelling, indicating potentially potent efficacy signal and lack of toxicity." — -Zacks Small-Cap Research

Francois Brisebois, Laidlaw & Company

(5/13/19)
"DURECT Corp. recently reported its Q1/19, very much in line with expectations with earnings per share of $0.04 as anticipated. . .we are encouraged by the company's clinical timeline remaining on track. It continues to expect its Phase 2 open label dose-escalation trial in alcoholic hepatitis and its Phase 1b open-label trial in nonalcoholic steatohepatitis, as well as its Phase 2a double-blind, vehicle-controlled proof of concept in psoriasis, to read out in H2/19."

The results compare favorably to those of the historical control group.
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Ed Arce, H.C. Wainwright & Co.

(5/9/19)
"Yesterday, DURECT Corp. hosted a key opinion leader session. . .a preliminary data analysis of 10 patients with alcoholic hepatitis (AH) in the ongoing open-label, dose escalation Phase 2a trial of lead drug DUR-928 showed meaningful improvements in key AH disease metrics: the Lille model, model of end-stage liver disease and bilirubin level."

Ed Arce, H.C. Wainwright & Co.

(4/18/19)
"Recently, on March 27, 2019, DURECT Corp. announced that it began enrollment for a Phase 1b dose-finding trial in nonalcoholic steatohepatitis. . .the company plans to report all data gathered in patients who have completed the trial in an initial data readout in H2/19, including imaging data. Therefore, positive results from this Phase 1b trial could enable the initiation of a new Phase 2 trial in H1/20 with the optimal dosage(s)."

Two recently launched clinical trials, and related conference calls, were reviewed in an H.C. Wainwright & Co. report.
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Ed Arce, H.C. Wainwright & Co.

(4/1/19)
"DURECT Corp. announced the initiation of an open-label, 28-day Phase 1b trial of oral DUR-928 in patients with nonalcoholic steatohepatitis. The company plans to enroll about 20 patients per dose group (low, middle, high) for a total of about 60 patients; initial data from this study, including safety, pharmacokinetics and signals of biologic activity, are expected in H2/19."

The company will discuss the trial when it hosts a conference call about this specific disease indication in April.
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This U.S. study follows encouraging results from a Phase 1b trial in the same indication in Australia.
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Brian Marckx, Zacks Small-Cap Research

(3/13/19)
"DUR-928 is where we continue to believe most of the upside value lies in DURECT Corp. . .the company has recently adopted somewhat of an updated strategy as it relates to DUR-928, which relates to honing its focus on accelerating timelines for those indications which it believes holds the most near-term potential to move into late-stage development with one of those areas being nonalcoholic steatohepatitis." -Zacks Small-Cap RResearch

This California company expects results from clinical trials in liver disease and psoriasis in 2019.
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A drug used to treat schizophrenic patients will launch commercially in February in the U.S.
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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, Healthcare Research Analyst – Laidlaw & Company
Patrick Dolezal – LifeSci Capital
headshot of Brian Marckx
Brian Marckx, CFA – Zacks Small-Cap Research
headshot of Grant Zeng
Grant Zeng, Senior Biotech Analyst – Zacks Investment Research, 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