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:

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."

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Ed Arce, H.C. Wainwright & Co.

(8/2/19)
"We are expecting substantial positive news flow from DURECT Corp. over the next five months as up to four potential stock catalysts could occur by year end: 1) full Phase 2a data readout from multiple dose cohorts of intravenous DUR-928 in patients with moderate-to-severe alcoholic hepatitis; 2) initial data from an open-label Phase 1b trial of DUR-928 in nonalcoholic steatohepatitis patients with stage 1–3 fibrosis; 3) topline data from a Phase 2a trial of DUR-928 in patients with mild to moderate plaque psoriasis; and 4) U.S. Food and Drug Administration approval of POSIMIR."

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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Francois Brisebois, Laidlaw & Company

(7/22/19)
"DURECT Corp. recently announced that it entered into an agreement with Gilead. . .we are encouraged by Gilead's $25 million upfront payment as DURECT finds itself in a stronger financial situation. . .this Gilead partnership could ultimately add visibility to DURECT's DUR-928 efforts from both the alcoholic hepatitis and nonalcoholic steatohepatitis perspective as Gilead has been dealing with recent failures and setbacks."

headshot of Ed Arce

Ed Arce, H.C. Wainwright & Co.

(7/22/19)
"This morning, in a positive surprise, DURECT Corp. announced that it has entered into an agreement with Gilead Sciences, granting Gilead the exclusive worldwide rights to develop and commercialize a long-acting injectable human immunodeficiency virus product (currently in preclinical development) utilizing DURECT's SABER technology. . .this collaboration provides substantial validation to the SABER platform, especially given that the core technology has been around for over a decade."

Ed Arce, H.C. Wainwright & Co.

(7/19/19)
"The U.S. Food and Drug Administration (FDA) has accepted DURECT Corp.'s full response to the complete response letter previously received on POSIMIR (bupivacaine extended-release solution) as a complete class 2 response (six-month review) and has set a December 27 PDUFA date. The agency is required to determine whether the filing constitutes a complete response within 60 days of submission. . .the FDA made its determination in just 20 days, which we view as exceedingly fast and a positive incremental sign of the likelihood of approval."

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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Brian Marckx, Zacks Small-Cap Research

(6/27/19)
"DURECT Corp. announced that it submitted a full response to the U.S. Food and Drug Administration's (FDA's) complete response letter for POSIMIR. . .as we had removed POSIMIR from our model, a favorable response from FDA would likely provide upside to our estimates. The market for POSIMIR could be substantial and, as such, potential revisions to our model could be as well." -Zacks Small-Cap Research

The company received approval to proceed with the next and final dose level.
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The results compare favorably to those of the historical control group.
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Two recently launched clinical trials, and related conference calls, were reviewed in an H.C. Wainwright & Co. report.
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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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This California company expects results from clinical trials in liver disease and psoriasis in 2019.
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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