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:

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

LifeSci Capital (11/8/18)
"DURECT Corp. received a $5M milestone upon approval of Indivior's Perseris for schizophrenia with quarterly single-digit earnouts on U.S. net sales, and the company is eligible for royalties on Orient Pharma's Methydur sustained release capsules which were recently approved in Taiwan."

Francois Brisebois, Laidlaw & Company (11/8/18)
"DURECT Corp. ended Q3/18 with $38.2M of cash and equivalents. We view its recent $20M debt amendment as positive since it enables the company to delay its principal payments by 18 months (commencing June 1, 2020 versus Dec. 1, 2018), which is a significant positive with its intent to start a NASH trial as soon as H1/19."

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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Grant Zeng, Zacks Small-Cap Research (8/6/18)
"DURECT Corp.'s total revenue for Q2/18 was $3.4M. . .as of June 30, 2018, cash and investments were $42.5M. . .we continue to be optimistic about the company's story. . .our fair value stands at $6/share solely based on the value of its DUR-928 programs." -Zacks Small-Cap Research

Ed Arce, H.C. Wainwright & Co. (8/2/18)
"DURECT Corp.'s Q2/18 earnings per share surprised on the upside due to lower-than-expected research and development and sales and marketing expenses. . .cash, cash equivalents and short-term investments were $42.5M at Q2/18E. . .we affirm our Buy."

A Laidlaw & Co. report discussed this firm's revenue and near-term, clinical catalysts.
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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

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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