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News Breaks
August 16, 2013
12:13 EDTPTIE, DRRXPain Therapeutics, DURECT up after Pfizer trial hits ClinicalTrials.gov
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News For PTIE;DRRX From The Last 14 Days
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May 18, 2015
08:31 EDTDRRXDURECT announces positive results from DUR-928 Phase 1 study
DURECT announced that it has obtained positive results from a multi-dose Phase 1 clinical trial with an oral formulation of DUR-928, the lead molecule in DURECT's Epigenomic Regulator Program. DUR-928 is an endogenous, small-molecule, new chemical entity, which may have broad applicability in metabolic diseases such as nonalcoholic fatty liver disease and nonalcoholic steatohepatitis. It may also play an important role in protecting against acute kidney injury and other types of acute organ injury. This Phase 1 trial was a single-site, randomized, double-blinded, placebo-controlled, multiple-ascending-dose study to evaluate the safety, tolerability, and pharmacokinetics of DUR-928 when orally administered once daily for 5 consecutive days to healthy volunteers. The 20-subject study evaluated DUR-928 in 2 consecutive 10-subject cohorts, the first receiving DUR-928 at a lower dose and the second at a higher dose. Following multiple dosing, DUR-928 was well-tolerated at both dose levels, with no clinically significant changes in vital signs, laboratory values or ECG parameters, no severe or serious drug-related adverse events reported and no subjects withdrawing from the study. Peak plasma concentrations achieved were at least 100-fold higher than endogenous levels, no accumulation in plasma concentrations were observed with repeat dosing, and dose related increases in plasma concentrations were observed with peak plasma concentration at approximately 2 6 hours after dosing.
May 12, 2015
16:25 EDTPTIEOn The Fly: Top stock stories for Tuesday
Stocks began the session deep in negative territory as bond yields in Europe and the U.S. were moving higher. The market saw its lows shortly after the open and soon began to recapture some of its losses. By noon, the losses were cut in half and the Dow made it all the way back to positive ground by the afternoon. Unable to gather any upside momentum, the rally stalled and the averages limped into the close. ECONOMIC EVENTS: In the U.S., the National Federation of Independent Business' small business optimism rose 1.7 points to 96.9 in April, versus expectations for a 96.0 reading. The JOLTs report showed job openings fell 150K to 4.99M in March, versus expectations for 5.11M openings. The 10-year U.S. Treasury yield climbed at high as 2.37% earlier in the session, which was its highest intraday mark since last November, before easing back by midday. Outside of the U.S., bond yields surged on 10-year notes in Japan, Italy, Spain, Portugal, and Germany. COMPANY NEWS: Shares of AOL (AOL) advanced $7.93, or 18.62%, to $50.52 after Verizon (VZ) agreed to buy the company for $50 per share in a deal valued at $4.4B. Verizon's John Stratton, speaking at the Jefferies 2015 Global TMT Conference, said the AOL deal was primarily about ad technology and Re/code reported that "one scenario" the service has heard about is that Verizon plans to spin off some or all of the content operations it is acquiring by buying AOL, such as the Huffington Post. Yahoo (YHOO) also rose 24c, or 0.55%, to $43.84, as Cantor Fitzgerald analyst Youssef Squali said he now views it as the "last remaining large scale digital media company of its kind." MAJOR MOVERS: Among the notable gainers was Pall Corp. (PLL), which advanced $19.31, or 19.44%, to $118.62 after The Wall Street Journal reported that the company is near a possible sale and listed Danaher (DHR) and Thermo Fisher (TMO) as potential buyers. Also higher was Pain Therapeutics (PTIE), which gained 68c, or 35.05%, to $2.62 after announcing that a study of its lead drug candidate, that is specifically designed to discourage certain common methods of drug tampering and misuse, demonstrated with statistical significance that both intact and chewed Remoxy were less "liked" than immediate-release oxycodone on the two primary endpoints of Drug Liking and Drug High. Among the noteworthy losers was ITT Educational Services (ESI), which plunged $1.75, or 43.53%, to $2.27 after the SEC announced that it had charged the company, along with its CEO and CFO, with fraud. Also lower were shares of NewLink Genetics (NLNK), which dropped $15.59, or 29.9%, to $36.55 after stating that it would continue its flagship IMPRESS trial as planned despite disclosing the FDA did not endorse management's plan to change the statistical analysis plan as defined in the original protocol. INDEXES: The Dow fell 36.94, or 0.2%, to 18,068.23, the Nasdaq slid 17.38, or 0.35%, to 4,976.19, and the S&P 500 dropped 6.21, or 0.29%, to 2,099.12.
08:14 EDTPTIEPain Therapeutics announces positive top-line results from study with Remoxy
Pain Therapeutics announced top-line results of an FDA Category 3 Human Abuse Potential Study with Remoxy Extended-Release Capsules CII, its lead drug candidate that is specifically designed to discourage certain common methods of drug tampering and misuse. This study demonstrated with statistical significance that both intact and chewed Remoxy were less "liked" than immediate-release oxycodone on the two primary endpoints, Drug Liking and Drug High. The Abuse Potential study was conducted in non-dependent, recreational opioid users, as recommended by FDA guidelines.
06:03 EDTPTIEPain Therapeutics to host conference call
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05:17 EDTPTIEPain Therapeutics announces update on drug portfolio
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