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:

A drug used to treat schizophrenic patients will launch commercially in February in the U.S.
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Francois Brisebois, Laidlaw & Company (1/14/19)
"DURECT Corp. recently provided a corporate update demonstrating their clear focus on DUR-928 and its ultimate potential in nonalcoholic steatohepatitis (NASH). . .DUR-928's ultimate value was always attached to NASH, and we view as a positive the company's decision to prioritize this angle as they now expect data this year. Additionally, we want to remind investors that DURECT will benefit from quarterly earnout payments (single-digit percentage of U.S. sales of Indivior's Perseris, expected to launch in Q1/19)."

Brian Marckx, Zacks Small-Cap Research (1/11/19)
"DURECT Corp.'s management accelerated the timeline for initial dosing of its new Phase 1b study of DUR-928 in nonalcoholic steatohepatitis. Previously expected to happen in H1/19 (which often implies Q2), this is now slated for Q1/19. . . meanwhile DUR-928 in psoriasis and alcoholic hepatitis also continues to make progress." -Zacks Small-Cap Research

Ed Arce, H.C. Wainwright & Co. (1/7/19)
"DURECT Corp. provided several updates on its clinical development of DUR-928. . .an open-label Phase 1b safety/pharmacokinetic study focusing on several nonalcoholic steatohepatitis-related biomarkers will begin enrollment in Q1/19 (previously H1/19), with an initial data readout in H2/19. The company also announced that it will transition the ongoing DUR-928 alcoholic hepatitis Phase 2a trial to Dr. Craig McClain at the University of Louisville."

Patrick Dolezal, LifeSci Capital (1/7/19)
"Today, DURECT Corp. provided a corporate update regarding the development strategy for lead candidate DUR-928. . .the company has guided on plans to discontinue DUR-928 development in primary sclerosing cholangitis. . .further, it is transitioning the alcoholic hepatitis program to Dr. Craig McClain of the University of Louisville, who has National Institutes of Health grants for funding."

The change relates to the onset of dosing for patients with different degrees of disease.
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Ed Arce, H.C. Wainwright & Co. (11/21/18)
"On Monday, Nov. 19, DURECT Corp. announced that it will begin enrolling severe alcoholic hepatitis (AH) patients, in a separate cohort, which is expected to significantly accelerate the overall timeline of its ongoing Phase 2a trial of lead drug DUR-928 in AH patients. . . if successful, this study could allow for a more accelerated regulatory pathway, potentially placing AH ahead in the timeline of other programs evaluating DUR-928."

Brian Marckx, Zacks Small-Cap Research (11/16/18)
"DURECT Corp.'s Q3/18 revenue of $8M benefited from a $5M milestone from Indivior related to U.S. Food and Drug Administration approval of Perseris (risperidone). . .recent progress on DUR-928 includes a protocol amendment that has the potential to speed the timeline of the Phase 2a alcoholic hepatitis clinical trial." -Zacks Small-Cap Research

A new, once-monthly injectable treatment for schizophrenia uses patents of a small-cap, U.S.-based pharmaceutical firm.
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Permission has been obtained to distribute time-release capsules.
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Company entitled to receive quarterly earn-out payments from patent agreement.
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More Expert Comments

Experts Following This Company

Ed Arce, Managing Direction and Senior Research Analyst – H.C. Wainwright & Co.
Francois Brisebois, Healthcare Research Analyst – Laidlaw & Company
Patrick Dolezal – LifeSci Capital
Brian Marckx, CFA – Zacks Small-Cap Research
Len Yaffe, Fund Manager, analyst, MD – Stoc*Doc Partners
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