DRRX stock has been running up the last two weeks ahead of the company’s January Advisory Committee meeting.
Bullish options flow was detected in DRRX stock on December 31, 2019:
The PDUFA date for POSIMIR for post-operative pain relief was set for December 27, 2019. However, the Advisory Committee meeting scheduled for January 16, 2020 will result in PDUFA date extension.
On November 20, 2019, the Federal Register filed a notice that the Anesthetic and Analgesic Drug Products Advisory Committee is scheduled to meet on January 16, 2020 to discuss the new drug application of Durect’s Posimir for the proposed indication of post-surgical analgesia. H.C. Wainwright analyst Ed Arce continues to expect approval of Posimir based on the existing safety and efficacy data portfolio from a number of completed trials. He affirms a Buy rating on Durect shares with a $4 price target.
On November 18, 2019, Cantor Fitzgerald analyst Eliana Merle assumed coverage of Durect with an Overweight rating and $5 price target. Eliana thinks DUR-928, a novel epigenetic regulator believed to have broad anti-inflammatory and metabolic benefits, and alcoholic hepatitis as an indication “remain largely under investors’ radar.” DUR-928 has shown survival outcomes and clinical metrics in alcoholic hepatitis patients over 28 days that physicians describe as striking, Merle tells investors in a research note. The analyst, who is cautious that these data were open label without a placebo, says that DUR-928’s clinical profile holds up in placebo controlled studies, she has conviction in its large commercial potential.
POSIMIR is the Company’s investigational post-operative pain relief depot product that utilizes DURECT’s patented SABER® technology. POSIMIR is designed to be administered directly into the surgical site to deliver bupivacaine for up to three days after surgery. POSIMIR has not been approved by the FDA for marketing in the U.S. for any indication.