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:

Positive results in a Phase 1b trial of DURECT Corp.'s candidate for the treatment of nonalcoholic steatohepatitis (NASH), which were presented at the 2017 International Liver Congress, prompted comments from a pair of analysts.
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Francois Brisebois, Laidlaw & Company (4/25/17)
"DURECT Corp. recently announced clinical Phase 1b data on its epigenetic regulator DUR-928 in nonalcoholic steatohepatitis (NASH). . .the full data set confirmed the [preliminary] findings with a single dose, which is a real positive in our opinion. . .we are encouraged by reduction levels in CK-18, hsCRP, bilirubin and IL-18 after a single oral dose of DUR-928 in NASH patients."

Reuters (4/23/17)
"DURECT Corp. is one of the many small companies developing drugs with a wide variety of approaches across the fatty liver disease spectrum that do not have partners. . .the eventual market for the complex disease, formally known as nonalcoholic steatohepatitis (NASH), is forecast to be $20–$35B. . .estimates for the prevalence of NASH in nations with fatty diets range from 5–20% of the population with up to 15M potentially affected in the United States alone."

David Sherman, LifeSci Capital (4/23/17)
"As part of our ongoing coverage of the 2017 International Liver Congress. . .we attended multiple poster sessions. . .DURECT Corp. focused on results of a pharmacokinetic study with DUR-928 for the treatment of NASH patients. This was an open-label Phase 1b study that assessed DUR-928 in NASH patients and matched control subjects (MCS). . .data indicate that NASH patients had 10-30% greater drug exposure as compared to MCS, and DUR-928 was well tolerated overall. . .preliminary biomarker data indicate reductions from baseline following dosing of DUR-928 in fCK-18, cCK-18, IL-18, and bilirubin. These data support the ongoing development of DUR-928 for the treatment of NASH, and investigators speculated on the plausibility of a therapeutic effect due to biomarker reductions at approximately 12 hours following dosing."

Management Q&A: View From the Top
James Brown
DURECT has a pipeline of drugs for a wide range of indications, from NASH to psoriasis to postoperative pain. In this interview with The Life Sciences Report, Dr. James Brown, DURECT's President and CEO, discusses the potentially groundbreaking epigenetic regulator DUR-928, POSIMIR's late-stage testing for postoperative pain and an abuse-deterrent oral technology.
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Grant Zeng, Zacks Equity Research (3/15/17)
"DURECT Corp.'s two Phase III candidates are Posimir and Remoxy. . .the company has initiated a new Phase III PERSIST trial with its clinical candidate Posimir. We estimate top line data will be available soon and the FDA approval will take place in late 2017 or early 2018. . .among the company's multiple candidates, we are especially optimistic about the company's epigenomic regulator program DUR-928, which holds great potential for multiple indications, such as NASH and acute kidney injury. . .our fair value for DURECT is $6.00 per share."

Jim Molloy, Laidlaw & Company (3/15/17)
"It is the expectation that the Sisyphean development of DURECT Corp.'s Posimir may be drawing to a conclusion. DRRX anticipates completing enrollment in the ongoing Phase 3 trial in 3Q17, which should mean top line data by year end-2017. . .the company will continue to enroll DUR-928 kidney and liver trials and presenting early data gathered to date through 2017. . .DRRX plans to start a Phase 2 trial in an oral formulation for primary sclerosing cholangitis. . .should Posimir read out positively and DUR-928 get out of Phase 1 trials, DRRX is an undervalued story here. We maintain our Buy rating, and our $3 price target."

Ed Arce, H.C. Wainwright & Co. (3/15/17)
"Near-term catalyst is DURECT Corp.'s Phase 1b data readout of DUR-928 in NASH patients at EASL, on April 19-23. . .results from two STAM NASH mouse models are planned to be presented at the AASLD Emerging Trends Conference 2017 in Washington D.C. on March 17. . .Beyond NASH, DURECT disclosed its Phase 2 development plans in an orphan disease, primary sclerosing cholangitis (PSC). . .DURECT provided a 4Q16 earnings update and indicated that they are actively working towards commencing a Phase 2 trial with an oral formulation of DUR-928 for PSC."

More Expert Comments

Experts Following This Company

Ed Arce, Managing Direction and Senior Research Analyst – H.C. Wainwright & Co.
Chen Lin What Is Chen Buying? What Is Chen Selling?
Jim Molloy, Analyst – Laidlaw & Company
Ram Selvaraju, Managing Director; Head of Healthcare Equity Research – Rodman & Renshaw
David Sherman, Analyst – LifeSci Capital
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