(RTTNews) - DURECT Corporation (DRRX) hit a new 52-week high of $2.19 on Friday, before closing at $2.14. The stock is up 345.8% year-to-date.
DURECT's lead product candidate, DUR-928 is a sulfated oxysterol which epigenetically modifies gene activity without changing the structure of DNA.
DUR-928 in IV form, proposed for the treatment of alcoholic hepatitis (AH) showed positive results in a Phase 2a trial. The results were announced last week. Additional data on this can be expected at the upcoming AASLD Liver Meeting in Boston in November.
DUR-928 in oral form, proposed for the treatment of Nonalcoholic steatohepatitis (NASH), is under Phase 1b study and patient enrollment started in March this year. Initial data from the study is expected in the second half of 2019.
DUR-928 for topical application is under phase IIa study for the treatment of Psoriasis. Topline data is expected in the second half of 2019.
Another drug candidate of the company is POSIMIR, a post-operative pain relief depot product that utilizes its patented SABER technology.
DURECT's resubmitted NDA for POSIMIR is under FDA review - with a decision expected by December 27, 2019. The drug was issued a Complete Response Letter by the U.S. regulatory agency in February 2014.
The company entered into an agreement with Gilead Sciences in July of this year to develop and commercialize a long-acting injectable HIV product utilizing the SABER technology. The product is under pre-clinical studies.
DURECT received an upfront payment of $25 million in July and a milestone payment of $10 million from Gilead on September 9, 2019.
Given the fact that the Company has upcoming clinical trial and regulatory catalysts, this stock is worth keeping an eye on.
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