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:

A small-cap American biotech has secured a patent agreement with a larger British firm, garnering the attention of three sector analysts.
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Adam Walsh, Stifel (10/2/17)
"DURECT Corp. has signed over some of its U.S. patent rights to Indivior in exchange for a $12.5M nonrefundable, upfront fee. . .while we view Indivior deal positively as DURECT is able to gain exposure to a late stage asset in a lucrative deal, we remain focused on Phase 3 PERSIST data expected 4Q17. . .we are positive on POSIMIR given the big pharma validation provided by the development and commercialization agreement with Sandoz AG. We view the $20M upfront payment as a signal of confidence for near-term approval prospects, and the lucrative back-end milestone/royalty payment structure as testament to the drug's significant longterm market potential."

Grant Zeng, Zacks Equity Research (10/2/17)
"DURECT Corp. announced a patent purchase agreement with Indivior UK Limited. . .pursuant to the agreement, DURECT has assigned certain of its U.S. patent rights to Indivior. This assignment may provide further intellectual property protection for RBP-7000, Indivior's investigational once-monthly injectable risperidone product for the treatment of schizophrenia. . .we think this is a great deal for Durect. The deal not only boosts Durect's balance sheet, but also validate the company's long-acting risperidone formulation technology."

Patrick Dolezal, LifeSci Advisors (10/2/17)
"DURECT Corp. announced that they have come to an agreement to sell a family of US patents to Indivior, which pertain to the intellectual protection of Indivior's once-monthly, injectable risperidone treatment RBP-7000 in development for schizophrenia. . .DURECT has received an upfront payment of $12.5 million, and is also eligible for $5 million in the event of FDA approval for RBP-7000, and single digit percentage payments based on net sales in the US. . .given the realized near-term revenue, and potential recurring, long-term revenues, we view this agreement as a favorable development for DURECT."

Ed Arce, H.C. Wainwright & Co. (8/14/17)
"DURECT Corp. confirmed that it expects to complete patient follow-up visits this quarter, and announce top-line results from the Phase 3 PERSIST study in 4Q17. . .DURECT announced the completion of enrollment at 296 patients, ahead of schedule and 12% above its 264-patient target. . .we continue to regard the recent U.S. commercialization agreement with Sandoz AG, as an important validating milestone. . .on positive Phase 3 data in 4Q, DURECT expects to resubmit the NDA in 1Q18, followed by an 8-month Priority Review by FDA leading to a likely product launch by Sandoz in late 2018."

Grant Zeng, Zacks Equity Research (8/10/17)
"We are especially optimistic about DURECT Corp.'s epigenetic regulator DUR-928, which holds great market potential for multiple indications, including NAFLD/NASH and acute kidney injury. Multiple Phase II trials will be initiated in 2017. . .we think Sandoz is a great deal for Durect. Sandoz has a very strong sales/marketing team and has a great presence in the US. . .we continue to be optimistic about Durect's story and maintain our price target at $7 per share based on the progress the company has made in advancing its candidates.

Patrick Dolezal, LifeSci Advisors (8/9/17)
"Highlights of the second quarter include reaching a commercialization agreement with Sandoz, completing enrollment of a pivotal Phase III trial for this asset, and completing drug-drug interaction studies and a Phase Ib trial for DUR-928. . .Durect announced on June 22nd that it has completed enrollment the PERSIST Phase III trial ahead of schedule. . .the Company expects to announce topline data in the fourth quarter of 2017. Durect completed drug-drug interaction studies of DUR-928, which showed no evidence of likely drug interactions. . .a Phase Ib trial of DUR-928 also demonstrated that the compound is well-tolerated in patients with moderate to severe kidney function impairment."

News about progress in two of this biotech's development programs prompted a rating upgrade by analyst Adam Walsh of Stifel Nicolaus & Company.
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With enrollment complete in its Phase 3 trial of a compound that treats post-operative pain, and an infusion of cash from a new partnership with a major pharmaceutical corporation, one analyst has initiated coverage of this California-based company, and another has reiterated his investment thesis.
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Ed Arce
NASH is an epidemic in the U.S., with more than 100 million people believed to be affected. Yet no FDA-approved treatments are available, with the exception of liver transplantation for end-stage disease. In part two of his interview with The Life Sciences Report, Ed Arce, managing director in equity research and senior analyst covering companies in the biopharmaceuticals and specialty pharmaceuticals sectors for H.C. Wainwright, and organizer of the recent inaugural NASH Investor Conference, says that small companies are rushing to fill the pipeline, with numerous compounds in trials.
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DURECT Corp. and Sandoz AG, a division of Novartis, have signed a development and commercialization agreement for the U.S. for POSIMIR.
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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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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
Jim Molloy, Analyst – Laidlaw & Company
Ram Selvaraju, Managing Director; Head of Healthcare Equity Research – Rodman & Renshaw
David Sherman, Analyst – LifeSci Capital
Adam Walsh, Analyst-Healthcare – Stifel
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
DURECT Corp. Content