Yesterday, 5:43 PM
Thu, May 21, 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%)
Mon, May 18, 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.
Mon, May 18, 9:15 AM
Tue, May 12, 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.
Thu, Apr. 30, 4:08 PM
Wed, Apr. 8, 1:05 PM
- The following companies are extended at least 30% above their 50-day moving averages, trade at least 500K shares per day, have market caps less than $500M and have poor fundamentals:
- (CAPN -7.6%)(AMRN +4.1%)(NYMX +3.6%)(CRMD -1.2%)(CNDO +6.8%)(ADXS +13.1%)(AXN +3.6%)(DRRX +4.9%)(CYTX -1.9%)(AVEO +2.6%)(RIGL +1.8%)(NVGN +10.5%)
- The list is not meant to provide Buy/Sell recommendations. It is a group of stocks that may warrant further research by individual investors.
Fri, Mar. 6, 12:45 PM
Tue, Mar. 3, 12:45 PM
Tue, Mar. 3, 10:41 AM
- Durect Corp. (DRRX +17.5%) Q4 results: Revenues: $4.3M (-0.7%); COGS: $1.2M (+20.0%); R&D Expense: $5.4M (+10.2%); SG&A: $3M (-14.3%); Operating Loss: ($5.4M) (-5.9%); Net Loss: ($5.9M) (-15.7%); Loss Per Share: ($0.05) (unch).
- FY2014 results: Revenues: $19.4M (+26.8%); COGS: $5.7M (+18.8%); R&D Expense: $22.4M (+18.5%); SG&A: $12.3M (-3.1%); Operating Loss: ($21M) (+0.9%); Net Loss: ($22.1M) (-2.8%); Loss Per Share: ($0.20) (+4.8%); Quick Assets: $32.7M (58.7%).
- No guidance given.
Mon, Mar. 2, 4:15 PM
Nov. 12, 2014, 7:42 AM
- In the minutes from Durect's (NASDAQ:DRRX) meeting with the FDA regarding Posidur, the agency indicated that it would be acceptable to run only one more clinical trial to assess the safety and efficacy of Posidur for the specific indication of soft tissue post-surgical analgesia rather than a broad indication which would require more than one study. The size of the trial has yet to be determined.
- The FDA sent the company a CRL on February 12, 2014 about Posidur stating it could not approve the NDA in its present form because it did not contain sufficient safety data.
- Previously: DURECT -29% AH as FDA denies approval for Posidur
Nov. 3, 2014, 4:10 PM
Nov. 3, 2014, 9:56 AM
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.
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