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.

(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."

headshot of Ed Arce

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."

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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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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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