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:

This U.S. study follows encouraging results from a Phase 1b trial in the same indication in Australia.
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Brian Marckx, Zacks Small-Cap Research

(3/13/19)
"DUR-928 is where we continue to believe most of the upside value lies in DURECT Corp. . .the company has recently adopted somewhat of an updated strategy as it relates to DUR-928, which relates to honing its focus on accelerating timelines for those indications which it believes holds the most near-term potential to move into late-stage development with one of those areas being nonalcoholic steatohepatitis." -Zacks Small-Cap RResearch

This California company expects results from clinical trials in liver disease and psoriasis in 2019.
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Francois Brisebois, Laidlaw & Company

(3/8/19)
"We see potential upside as DURECT Corp. should start receiving quarterly single-digit earnout payments on U.S. sales of Indivior's Perseris (Indivior expects peak sales of $200–300M), which launched in the U.S. in February 2019. . .we see 2019 as a key year for DUR-928, which we continue to believe is the main reason to own the stock, and see the current valuation as an interesting buying opportunity."

headshot of Ed Arce

Ed Arce, H.C. Wainwright & Co.

(3/8/19)
"DURECT Corp. reported that an ongoing Phase 2a open-label, multicenter, dose escalating trial (NCT03432260) has progressed to its Part B with severe alcoholic hepatitis (AH) patients in the 90 mg dose group. This decision was based on positive results in both moderate and severe AH patients who were given the 30 mg doses and the rapid pace of enrollment in Part B."

Francois Brisebois, Laidlaw & Company

(2/28/19)
"DURECT Corp. expects to submit its complete response letter (CRL) response in H1/19 and anticipates a six-month U.S. Food and Drug Administration review period. With additional safety data from its PERSIST trial, which was ultimately completed for safety, we are encouraged by DRRX's decision to proceed with a full response to the CRL."

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Ed Arce, H.C. Wainwright & Co.

(2/28/19)
"DURECT Corp.'s Posimir comes back in play. Yesterday, the company announced its plan to submit a full response to the U.S. Food and Drug Administration's complete response letter (CRL) that was issued on the new drug application of Posimir for postoperative pain, in February 2014. . .after an exhaustive review of data from 16 completed clinical trials of Posimir, DURECT now believes that it has accumulated a data portfolio that specifically addresses the issues raised in the CRL, thereby supporting its approval."

Patrick Dolezal, LifeSci Capital

(2/27/19)
"DURECT Corp. announced plans to respond to a complete response letter for Posimir, the company's long-acting bupivacaine formulation for postoperative pain, originally issued by the U.S. Food and Drug Administration in 2014. This response is based on thorough evaluation of available data related to Posimir, including additional safety data from the PERSIST trial that DURECT has guided are key in addressing the agency's original concerns."

A drug used to treat schizophrenic patients will launch commercially in February in the U.S.
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The change relates to the onset of dosing for patients with different degrees of disease.
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A new, once-monthly injectable treatment for schizophrenia uses patents of a small-cap, U.S.-based pharmaceutical firm.
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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
headshot of Grant Zeng
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