DURECT's Endogenous Epigenomic Regulator DUR-928 - What You Need To Know
Jason Napodano, CFA
Jason Napodano, CFA
Durect Shares Should Double In The Next Year
Jason Napodano, CFA • 12 Comments
Jason Napodano, CFA • 12 Comments
Thu, May 19, 10:35 AM
- DURECT (DRRX +1.7%) announces that the FDA's Anesthetic and Analgesic Drug Products Advisory Committee will meet on August 5 to discuss the New Drug Application (NDA) filed by licensee Pain Therapeutics (PTIE -0.2%) seeing approval of REMOXY (oxycodone capsules CII) for the treatment of pain severe enough to require daily, around-the-clock. long-term opioid treatment.
- The PDUFA date remains September 25.
Thu, May 5, 4:49 PM
Tue, Apr. 26, 9:16 AM
Tue, Apr. 26, 7:49 AM
- DURECT Corp. (NASDAQ:DRRX) is down 7% premarket on light volume in response to its announcement that it is preparing an equity offering. Price, volume and terms have yet to be announced. Net proceeds will be used for general corporate purposes.
- Update: The offering is 12M shares of common stock at $1.25 per share. Underwriters over-allotment is an additional 1.8M shares. Closing date is April 29.
Tue, Apr. 12, 6:00 PM
- The FDA accepts for review Pain Therapeutics' (NASDAQ:PTIE) New Drug Application (NDA) seeking approval of lead product candidate REMOXY, an abuse-deterrent formulation of extended-release oxycodone capsules. The agency's action date (PDUFA) is September 25. This is the third attempt at approval.
- REMOXY's abuse-deterrence characteristics are based on Durect's (NASDAQ:DRRX) ORADUR technology which uses a high viscosity base component to provide controlled release of the active ingredient over 12-24 hours. Pain Therapeutics licensed the technology in 2002.
- Management will host a conference call tomorrow morning at 8:30 am ET to discuss the NDA and the market opportunity.
- Shares are up 2% after hours on robust volume.
- Previously: Pain Therapeutics tries again with REMOXY NDA (March 29)
Tue, Mar. 29, 10:37 AM
- Pain Therapeutics (PTIE -1.9%) files its New Drug Application (NDA) with the FDA seeking approval of REMOXY, an abuse-deterrent formulation of extended-release oxycodone capsules, for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment.
- The filing is a resubmission. The original NDA was filed by the company in June 2008. It received a CRL six months later. King Pharmaceuticals, who assumed control of development in March 2009, resubmitted the NDA in December 2010. The FDA responded with another CRL to Pfizer (acquired King in February 2011) in June 2011. The issues pertained principally to manufacturing consistency and how it related to the consistency of the drug inside the body. Pfizer eventually gave up and returned the rights to the drug to Pain Therapeutics in October 2014.
- REMOXY's abuse-deterrence characteristics are based on Durect's (DRRX -0.8%) ORADUR technology which uses a high viscosity base component to provide controlled release of the active ingredient over 12-24 hours. Pain Therapeutics licensed the technology in 2002.
- Previously: Pain Therapeutics' oral oxycodone successful in abuse deterrent study; shares rise (May 12, 2015)
Mon, Feb. 29, 4:25 PM
Tue, Feb. 2, 8:02 AM
- The FDA designates privately held Cambridge, MA-based Nimbus Therapeutics' NDI-010976 for Fast Track review for the treatment of nonalcoholic steatohepatitis (NASH).
- NDI-010976 inhibits an enzyme called aceyl-COa carboxylase that plays a key role in the metabolism of fatty acids. A Phase 2 clinical trial is expected to commence in H1.
- NASH-related tickers: (NASDAQ:ICPT)(NASDAQ:TBRA)(NASDAQ:MNOV)(NASDAQ:GLMD)(NASDAQ:RGLS)(NYSE:AZN)(NASDAQ:DRRX)(NASDAQ:CNAT)(NASDAQ:VBLT)(NYSE:MRK)(NASDAQ:SHPG)(NASDAQ:GILD)(NASDAQ:GALT)(OTCPK:GNFTF)(NYSEMKT:CANF)
Nov. 16, 2015, 8:21 AM
- The design of a pivotal Phase 3 clinical trial assessing GENFIT's (OTCPK:GNFTF) lead product candidate, Fast Track-tagged Elafibranor (GFT505), for the treatment of non-alcoholic steatohepatitis (NASH) has been finalized. The study is set to commence this quarter.
- The 1,800-subject, randomized, double-blind, placebo-controlled trial will be conducted across 200 centers worldwide. The study population will include NASH patients who have a NAFLD Activity Score (NAS) of at least 4, with F2 (light) or F3 (severe) fibrosis. Participants will receive 120 mg of Elafibranor or placebo once daily. An interim analysis will be performed on the first 900 patients after 72 weeks that will support initial regulatory approval. To support full approval, the trial will continue to conclusion to show the impact of Elafibranor on the prevention of cirrhosis and other liver-related outcomes on the full study population. A group of F1 fibrotic patients who have cardiometabolic co-morbidities will be enrolled as well. The study will continue post-marketing and will remain blinded after the interim analysis. All patients will be followed until the occurrence of a pre-defined number of progressions to cirrhosis or other liver-related events.
- The primary endpoint is the resolution of NASH without worsening of fibrosis.
- NASH-related tickers: (NASDAQ:TBRA)(NASDAQ:ICPT)(NASDAQ:DRRX)(NASDAQ:MNOV)(NASDAQ:GLMD)(NASDAQ:RGLS)(NYSE:AZN)(NASDAQ:CNAT)(NASDAQ:VBLT)(NASDAQ:RPTP)(NYSE:MRK)(NASDAQ:SHPG)(NASDAQ:GILD)(NASDAQ:GALT)
Nov. 2, 2015, 4:18 PM
- Durect (NASDAQ:DRRX): Q3 EPS of -$0.05 in-line.
- Revenue of $4.7M (+10.3% Y/Y) misses by $0.38M.
Aug. 3, 2015, 4:07 PM
- Durect (NASDAQ:DRRX): Q2 EPS of -$0.05 beats by $0.01.
- Revenue of $4.4M (-3.9% Y/Y) misses by $0.61M.
Jul. 1, 2015, 11:30 AM
- Galectin Therapeutics (GALT -0.7%) announces the screening of the first five patients in its Phase 2 study, called NASH-CX, evaluating GR-MD-02 in patients with nonalcoholic steatohepatitis (NASH). The randomized, placebo-controlled study will enroll 156 patients who will receive either one of two doses of GR-MD-02 (2 mg/kg or 8 mg/kg) or placebo. Final data collection is expected in October 2017. The study completion date is February 2018.
- The primary endpoint is the reduction in hepatic portal vein pressure versus placebo as measured by the hepatic venous pressure gradient (HVPG).
- GR-MD-02, the company's lead product candidate in its fibrosis program, is a complex carbohydrate drug that targets galectin-3, a protein that plays a key role in the pathogenesis of fatty liver disease and fibrosis. The FDA designated it for Fast Track review for the treatment of NASH in August 2013.
- NASH is one of the "next big things" for drug makers. It affects as many as 5% of Americans.
- Related tickers: (TBRA +1.7%)(ICPT -1%)(DRRX +0.4%)(MNOV +1.9%)(GLMD)(RGLS -6.3%)(AZN +1.2%)(OTCPK:GNFTF)(CNAT +4.3%)(VBLT +0.2%)(RPTP +2.7%)(LJPC +10.4%)(MRK +1.3%)(SHPG +1.4%)(OTCQB:ISLT)(GILD -0.4%)
Jun. 23, 2015, 12:49 PM
- Based on guidance from the FDA, Durect (DRRX +9.8%) plans to conduct a new Phase 3 study evaluating POSIDUR (SABER-Bupivacaine) for the management of postoperative pain in patients undergoing gall bladder surgery (laparoscopic cholecystectomy). Enrollment will commence in the fall with top-line results expected by late 2016.
- In a previous study involving 50 patients, treatment with POSIDUR showed a 25% reduction in pain intensity on movement for the first three days after surgery compared to the active control bupivacaine hydrochloride.
- POSIDUR is a long-acting formulation of bupivacaine.
- The company received a Complete Response Letter (CRL) in February 2014 stating that its New Drug Application (NDA) was not approvable in its present form because it did not contain sufficient safety data.
- Previously: One more safety trial needed for Posidur approval (Nov. 12, 2014)
Jun. 23, 2015, 12:46 PM
Jun. 16, 2015, 12:51 PM
May 26, 2015, 5:43 PM
DURECT Corp. is a specialty pharmaceutical company, which engages in development of pharmaceutical products for pain and chronic diseases based on its proprietary drug delivery technology platforms. It manufactures and sells osmotic pumps used in laboratory research, and designs, develops and... More
Industry: Drug Manufacturers - Other
Country: United States
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