Durect Corporation (DRRX) - NASDAQ
  • Tue, Apr. 26, 9:16 AM
    | 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. 26, 7:49 AM
  • 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:DRRXORADUR 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, Apr. 12, 6:00 PM | 2 Comments
  • Jun. 23, 2015, 12:46 PM
    | Jun. 23, 2015, 12:46 PM | 1 Comment
  • Jun. 16, 2015, 12:51 PM
    | Jun. 16, 2015, 12:51 PM
  • May 26, 2015, 5:43 PM
    | May 26, 2015, 5:43 PM | 3 Comments
  • May 21, 2015, 10:58 AM
    • Thinly traded nano cap Intellipharmaceutics (IPCI +17.3%) heads north on a 10x surge in volume in response to its announcement that the FDA may not require a Phase 3 study for its abuse-deterrent opioid candidate, Rexista Oxycodone XR, if bioequivalence to Purdue Pharma's Oxycontin is demonstrated. The company believes that its previously completed Phase 1 trials fulfill this criterion.
    • The firm intends to file its New Drug Application (NDA) within the next 6 - 12 months. Approval is not guaranteed, however. After reviewing the data, the FDA may still require further studies.
    • Rexista Oxycodone XR's formulation deters abuse by instantaneously coagulating and entrapping the drug in a viscous hydrogel when pulverized and hydrated. It is also designed to prevent dose dumping if taken with alcohol.
    • Related tickers: (PTIE -1.9%)(DRRX)(COLL +1.9%)(ZGNX)(MNK -0.3%)(ACT +1.1%)(TEVA +1.6%)(ABBV -0.7%)(LCI -0.7%)(ALKS -1%)(EGLT -0.1%)(PFE -0.2%)(ACUR -2.4%)
    | May 21, 2015, 10:58 AM | 12 Comments
  • May 18, 2015, 9:26 AM
    • Durect (NASDAQ:DRRX) is up 11% premarket on increased volume in response to its announcement of results from a multiple-ascending dose Phase 1 study of DUR-928, a small molecule drug candidate that modulates the activity of various nuclear receptors involved in liver homeostasis (stable function). It is under development for the potential treatment of nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH).
    • The 20-subject single-site, randomized, double-blind, placebo-controlled multiple-ascending-dose study assessed the safety, tolerability and pharmacokinetics of DUR-928, orally administered once daily for five consecutive days in healthy volunteers. DUR-928 was well tolerated and no severe or serious drug-related adverse events were observed. Peak plasma concentration levels were at least 100x higher that the levels occurring naturally with no accumulation seen with repeat dosing.
    • The company acquired the global rights to DUR-928 from the Department of Internal Medicine at Virginia Commonwealth University, VCU Medical Center and the McGuire VA Medical Center. It intends to proceed to Phase 2 development this year. A Phase 1 trial for an injectable version of DUR-928 should commence in H2.
    | May 18, 2015, 9:26 AM
  • May 18, 2015, 9:15 AM
    | May 18, 2015, 9:15 AM | 3 Comments
  • May 12, 2015, 8:35 AM
    • An FDA Category 3 Human Abuse Potential Study with Pain Therapeutics' (NASDAQ:PTIE) Remoxy (oxycodone) Extended-Release Capsules CII showed that both intact and chewed Remoxy was less "liked" than immediate-release oxycodone as measured by the two primary endpoints of Drug Liking and Drug High. The Abuse Potential study was conducted in non-dependent recreational opioid users, per FDA guidelines.
    • Remoxy is an oral, long-acting oxycodone gelatin capsule that is being developed by PTIE under a 2002 agreement with Durect (NASDAQ:DRRX). It is formulated with the Durect's ORADUR technology, which uses a high viscosity base component to provide controlled release of the active ingredient over 12 - 24 hours.
    • PTIE will host a conference call today at 4:30 pm ET to discuss its progress with its drug candidates and to field questions.
    • PTIE shares are up 31% premarket on light volume.
    | May 12, 2015, 8:35 AM
  • Mar. 6, 2015, 12:45 PM
    | Mar. 6, 2015, 12:45 PM | 2 Comments
  • Mar. 3, 2015, 12:45 PM
    | Mar. 3, 2015, 12:45 PM | 4 Comments
  • Oct. 27, 2014, 12:49 PM
    | Oct. 27, 2014, 12:49 PM
  • Oct. 27, 2014, 9:26 AM
    • Durect Corp. (NASDAQ:DRRX) and Pain Therapeutics (NASDAQ:PTIE) drop 46% and 54%, respectively, on robust volume after Pfizer (NYSE:PFE) decides to discontinue its agreement to development and commercialize Romoxy (oxycodone).
    • Pfizer will return all rights, including the responsibility for regulatory activities to Pain, who licensed the product from Durect.
    | Oct. 27, 2014, 9:26 AM | 3 Comments
  • Oct. 27, 2014, 9:13 AM
    | Oct. 27, 2014, 9:13 AM | 1 Comment
  • Jun. 27, 2014, 12:47 PM
    | Jun. 27, 2014, 12:47 PM | 2 Comments
Company Description
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
Sector: Healthcare
Industry: Drug Manufacturers - Other
Country: United States