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:

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."

Francois Brisebois, Laidlaw & Company (8/9/17)
"DURECT Corp.'s Posimir remains front and center, in our opinion, as DRRX was able to execute the US commercialization agreement with Sandoz. . .we continue to see Sandoz as an ideal partner due to their impressive hospital presence and sales expertise. Management still anticipates PERSIST to read out in 4Q17. . .DRRX reiterated their intent to initiate a Phase 2 trial for oral DUR-928 in primary sclerosing cholangitis (PSC) by YE17. On the back of a solid deal with Sandoz and with more catalysts to come in 2017 such as Posimir Phase 3 readout in 4Q17 and IND filings for DUR-928, we see potential near-term upside."

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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Adam Walsh, Stifel (7/12/17)
"There are good reasons to believe DURECT Corp.'s upcoming Phase III PERSIST results will be positive and finally pave the road to approval. We forecast Posimir approval/launch in 1H/19 and project FY25 peak unadjusted sales of $381M, yielding $65M in royalties to Durect. . .Posimir’s higher dose of bupivacaine and and longer duration of efficacy relative to Exparel, along with competitive pricing, will enable DURECT to carve a niche with surgeons seeking extended pain relief. We assume a price point of ~$285/treatment, in-line with Exparel. . . .based on our NPV analysis, Posimir contributes $1.18/share to our $3 Target Price valuation."

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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Patrick Dolezal, LifeSci Capital (6/29/17)
"DURECT Corp. is a biopharmaceutical company with a rich development pipeline that includes an epigenetic regulator program and a portfolio of 505(b)(2) programs. . .the Company is focused on the development of DUR-928, an endogenous epigenetic regulator with potential in chronic liver diseases, acute organ injury, and inflammatory conditions. Durect is also developing Posimir, a long-acting local anesthetic based on the Company’s proprietary SABER technology, for the treatment of post-operative pain."

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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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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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
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
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

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