Feb 17, 2021
[6 min Read]
Current Price- $2.7
Price Target - $6.67 with a high of $8 ( WSJ Markets https://www.wsj.com/market-data/quotes/DRRX/research-ratings, CNN Business - https://money.cnn.com/quote/forecast/forecast.html?symb=DRRX)
CNN Business - The 6 analysts offering price forecasts for DURECT Corp have a median target of 6.50, with a high estimate of 8.00 and a low estimate of 5.00.
The current consensus among 6 polled investment analysts is to buy stock in DURECT Corp. This rating has held steady since December, when it was unchanged from a buy rating.
-DURECT Corporation Announces First Patient Dosed in Phase 2b AHFIRM Study of DUR-928 in Severe Alcohol-Associated Hepatitis
DURECT's lead drug candidate, DUR-928, is an endogenous sulfated oxysterol and an epigenetic regulator. It represents a new class of therapeutics with a unique mechanism of action. DUR-928 epigenetically modulates the expression of multiple clusters of master genes that are involved in many important cell signaling pathways, through which it stabilizes mitochondria, reduces lipotoxicity, regulates inflammatory or stress responses, and promotes cell survival.
AHFIRM is a Phase 2b clinical trial evaluating the potential life-saving capacity of DUR-928 in patients with severe AH. AHFIRM is a randomized, double-blind, placebo-controlled, international, multi-center study to evaluate the safety and efficacy of DUR-928 in approximately 300 patients with severe AH. The study will be comprised of three arms of approximately 100 patients each: (1) DUR-928 (30 mg); (2) DUR-928 (90 mg); and (3) Placebo plus standard of care (SOC). SOC may include the use of methylprednisolone, a corticosteroid, at the discretion of the treating physician. Patients will receive an intravenous (IV) dose of DUR-928 or placebo (sterile water) on day 1 and a second IV dose on day 4 if they are still hospitalized. The primary outcome measure will be 90-day survival rate for patients treated with DUR-928 compared to those treated with placebo plus SOC. Secondary endpoints include 28-day survival, the rate of adverse events, Lille and MELD (prognostic scores), and time in the intensive care unit. The Company is targeting 40-50 clinical trial sites in the US and Europe. For more information, refer to ClinicalTrials.gov Identifier: NCT04563026
-DURECT Corporation Announces U.S. FDA Approval of POSIMIR® For Post-Surgical Pain Reduction for up to 72 Hours Following Arthroscopic Subacromial Decompression
DURECT Corporation (Nasdaq: DRRX) today announced that the U.S. Food and Drug Administration (FDA) has approved POSIMIR® (bupivacaine solution) for infiltration use in adults for administration into the subacromial space under direct arthroscopic visualization to produce post-surgical analgesia for up to 72 hours following arthroscopic subacromial decompression. The approval was based on positive data from a randomized, multicenter, assessor-blinded, placebo-controlled clinical trial in patients undergoing arthroscopic subacromial decompression surgery with an intact rotator cuff. The primary outcome measures were mean pain intensity and total opioid rescue analgesia administered, both evaluated over the first 72 hours after surgery versus placebo. POSIMIR demonstrated a statistically significant improvement in both primary outcome measures: a 1.3 point, or 20%, reduction in mean pain intensity on a 0-10 point pain scale (p=0.01), and a 67% reduction in I.V. morphine-equivalent rescue opioid use, from a median of 12 mg in the placebo group to 4 mg in the POSIMIR group (p=0.01). Please see important safety information including the Boxed Warning below and the POSIMIR full prescribing information.
"We are excited to announce the approval of POSIMIR, a novel, non-opioid, sustained-release local analgesic for the treatment of post-surgical pain following arthroscopic subacromial decompression surgery," said James E. Brown, President and CEO of DURECT. "This FDA approval provides an important new option to help orthopedic surgeons in their efforts to minimize opioid use while managing acute pain for up to 72 hours after this painful surgery."
"In my experience, POSIMIR was easy to administer into the subacromial space under arthroscopic guidance, where it can directly address the source of postsurgical pain," said Sten Rasmussen, MD CBE PhD, Associate Professor, Department of Orthopaedic Surgery, Aalborg University Hospital, and Professor and Head of the Department of Clinical Medicine, Aalborg University, Denmark, a principal investigator in the POSIMIR registration trial. "A non-opioid product providing up to three days of local analgesia would be a significant benefit to patients."
"The first 72 hours after surgery are typically when patients experience the most severe postsurgical pain," said T J Gan, MD MHS FRCA MBA, Professor and Distinguished Endowed Chair, Department of Anesthesiology at Stony Brook University Renaissance School of Medicine. "So, a new sustained-release product providing continuous analgesia during this critical period is a welcome addition to the armamentarium for anesthesiologists and surgeons, especially as we aim to reduce the use of postsurgical opioids whenever possible."
POSIMIR (bupivacaine solution) for infiltration use is a novel and proprietary product that combines the strength of 660 mg of bupivacaine base with the innovative SABER® platform technology, enabling continuous sustained delivery of a non-opioid local analgesic over 3 days in adults. POSIMIR contains more bupivacaine than any other approved single-dose sustained-release bupivacaine product. At the end of surgery, POSIMIR is administered into the subacromial space under direct arthroscopic visualization, where it continuously releases bupivacaine for 72 hours or more. DURECT is in discussions with potential partners regarding the licensing of commercialization rights to POSIMIR, for which DURECT holds worldwide rights.
Indications and Usage
POSIMIR (bupivacaine solution) for infiltration use is indicated in adults for administration into the subacromial space under direct arthroscopic visualization to produce post-surgical analgesia for up to 72 hours following arthroscopic subacromial decompression.
-DURECT Corporation to Sell its LACTEL® Absorbable Polymer Product Line to Evonik for $15 Million
DURECT Corporation (Nasdaq: DRRX) announced that it has signed an agreement to sell its LACTEL Absorbable Polymer (LACTEL) product line to Evonik, a global leader in specialty chemicals.
Under the terms of the agreement, Evonik will pay DURECT $15 million in exchange for certain assets and liabilities associated with LACTEL product line based in Birmingham, Alabama, plus an additional potential payment based on full year EBITDAS results. The transaction is expected to close by Q1 2021 pending the satisfaction of certain customary closing conditions. An offer will be extended to each of the 15 employees of DURECT located in Birmingham, Alabama, which are associated with the LACTEL® business to transition to Evonik.
"It has been a pleasure working with the highly motivated and talented LACTEL team. We have confidence that Evonik will apply its resources and commitment to excellence to enable the LACTEL product line and supporting team members to thrive," said James E. Brown, President and CEO of DURECT. "This deal makes strategic sense for DURECT as we continue to focus on epigenetic regulation and the development of DUR-928 for alcohol-associated hepatitis and other acute organ injury and chronic liver diseases. We wish all of our LACTEL colleagues the very best going forward."
"The acquisition of the LACTEL® business will strengthen both our innovation growth field Healthcare Solutions and Evonik's position as a globally leading CDMO for drug delivery solutions," says Johann-Caspar Gammelin, Head of the Nutrition & Care Division of Evonik. "The acquisition of the LACTEL® business marks a consequential step in the growth agenda of the life-science division Nutrition & Care. The LACTEL® business will benefit from fast-growing markets such as advanced drug delivery, biomaterials for tissue engineering, and the 3D printing of implantable medical devices."
Evonik is one of the world leaders in specialty chemicals. The company is active in more than 100 countries around the world and generated sales of €13.1 billion and an operating profit (adjusted EBITDA) of €2.15 billion in 2019. Evonik goes far beyond chemistry to create innovative, profitable and sustainable solutions for customers. The focus of Evonik's Nutrition & Care division is on health and quality of life. It develops differentiated solutions for active pharmaceutical ingredients, medical devices, nutrition for humans and animals, personal care, cosmetics, and household cleaning. In these resilient end markets, the division generated sales of around €2.9 billion in 2019 with about 5,300 employees.