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 Ed Arce

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)."

Ed Arce, H.C. Wainwright & Co.

(9/10/19)
"DURECT Corp. announced that it has earned a $10M milestone payment from Gilead related to the further development of an investigational injectable HIV product utilizing DURECT's SABER technology, as part of a license agreement that was announced in July 2019. In addition to the $25M upfront payment already received, remaining milestones include the potential for up to an additional $65M in development and regulatory milestones, up to an additional $70M in sales-based milestones, as well as tiered royalties on product sales."

headshot of Brian Marckx

Brian Marckx, Zacks Small-Cap Research

(8/19/19)
"DURECT Corp.'s licensing agreement with Gilead not only brings substantial upfront capital ($25M) and potential subsequent related income ($145M or more), but also further validates the utility and diversity of the SABER platform technology. We think it is particularly noteworthy given Gilead's leading position in the HIV therapeutic space, a fact that will also hopefully bode well for chances of eventual development and commercial success of the products covered under this licensing arrangement." -Zacks Small-Cap Research

Francois Brisebois, Laidlaw & Company

(8/2/19)
"DURECT Corp. recently reported its Q2/19 very much in line with expectations as earnings per share hit our anticipated $0.04. We are particularly encouraged with recent developments at the company leading to a substantial influx of capital."

The specifics and benefits of the deal are discussed in an H.C. Wainwright & Co. report.
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The two California-based companies will collaborate on specific related development activities.
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The FDA deemed the firm's submission for analgesic approval complete.
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The firm believes adequate therapeutic safety and efficacy data exist to support regulatory approval.
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The company received approval to proceed with the next and final dose level.
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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

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