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Extreme FDA Calendar Trades: 18 Stocks Under $5

Mon, 06 Jul 2009 00:54:16 GMT

Below are extreme trades among 18 companies with stock prices under $5 from the BioMedReports.com FDA Calendar, which includes 232 entries as of 7/3/09. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of BioMedReports.com, the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA fili (...)[More...]

FDA Calendar Updates: BDSI Is Worth The Wait, Zicam Warning

Wed, 17 Jun 2009 00:36:58 GMT

Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of over 200 entries. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of BioMedReports.com, the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response lette (...)[More...]

Earnings Summary: Wednesday, March 12, 2008

Thu, 13 Mar 2008 06:13:37 GMT

Ticker: JMP,GNTA,IRN,WX,VM,ALFA,QLTY,AMIE,VOL,PPCO,ANH,STAN,WON,END,ENZ,RAVN,DCGN,NGAS,SGXP,AFCE,CGPI,CYTX,EVOL,GDP,GYMB,HOTT,JAS,JASO,LL,MHGC,MW,NP,PRSC,TBSI,TLB,TRK,VSE,AERG,CODI,FSIN,GLBC,HRLY,MDZ,MED,SUSS,GPOR,SIGM,CADX,ARYX,GSAT,BMTI[More...]

ARYx Therapeutics Reports Second Quarter 2009 Results

Thu, 13 Aug 2009 11:55:00 GMT

ARYx Therapeutics, Inc. (NASDAQ:ARYX) today reported results of operations and provided a general business update for the second quarter ended June 30, 2009.
"During the second quarter, we completed the Phase 2/3 EmbraceAC clinical trial comparing tecarfarin, ARYx's novel oral anticoagulant, to warfarin and have now completed extensive subanalyses of the data.
As we continue to discuss the trial results with potential tecarfarin partners, we are also planning to meet with the Food and Drug Administration (FDA) to confirm the regulatory path to approval for the compound.

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ARYx Therapeutics Schedules Second Quarter 2009 Results Conference Call

Wed, 05 Aug 2009 11:05:00 GMT

ARYx Therapeutics Inc (NASDAQ:ARYX), a biopharmaceutical company, announced today that a conference call to discuss second quarter 2009 results and to provide a general business update will be held on Thursday, August 13, 2009 at 8:00 a.m. Pacific Time.[More...]

ARYx Therapeutics Announces Results of Phase 2/3 Clinical Trial on Anticoagulant Agent Tecarfarin

Wed, 08 Jul 2009 01:57:00 GMT

ARYx Therapeutics, Inc. (NASDAQ:ARYX), a biopharmaceutical company, today announced results from its Phase 2/3 clinical trial, EmbraceAC, comparing its novel anticoagulant agent tecarfarin (previously ATI-5923) with the leading oral anticoagulant warfarin. In this trial, tecarfarin demonstrated efficacy essentially the same as in earlier Phase 2 studies but did not achieve the primary endpoint of superiority over warfarin, as measured by time in therapeutic range (TTR). This was due to the virtually unprecedented performance of warfarin in this trial. Using the International Normalized Ratio (INR), which is the standard measure of anticoagulation to evaluate TTR, the patients in the trial who were administered tecarfarin stayed within the target therapeutic range 74.0% of the time treated as compared to those patients receiving warfarin who stayed within the target therapeutic range 73.2% of the time (p=0.506). The result for the warfarin group was unexpected based upon the extensive history of prior studies and published literature for the drug. Tecarfarin appeared to be well tolerated by the patients in this Phase 2/3 clinical trial.[More...]

ARYx Therapeutics Inc. Updates Progress with Tecarfarin EmbraceAC Study

Tue, 16 Jun 2009 11:26:00 GMT

ARYx Therapeutics Inc. (NASDAQ:ARYX), a biopharmaceutical company, announced today that the database for the EmbraceAC study has been locked and the study remains on schedule, with the efficacy and safety results to be available during the week of July 6, 2009. The study was designed to compare its oral anticoagulation therapy, tecarfarin (previously ATI-5923), against the leading anticoagulant agent, warfarin. The purpose of the trial is to evaluate whether tecarfarin is superior to warfarin in its ability to maintain patients within a target therapeutic range of the level of anticoagulation as measured by INR (International Normalized Ratio). Based upon recent interactions with the U. S. Food and Drug Administration (FDA), ARYx believes this trial could be positioned as one of the required registration studies for tecarfarin.[More...]

ARYx to Present at the Jefferies 3rd Annual Healthcare Conference

Wed, 10 Jun 2009 11:26:00 GMT

ARYx Therapeutics, Inc. (NASDAQ:ARYX) today announced that it will present at the Jefferies & Company 3rd Annual Healthcare Conference on Wednesday, June 17, 2009 at 2:45 p.m. Eastern Time. A live webcast of the presentation may be accessed at the ARYx website http://www.aryx.com. The presentation will be archived for 30 days.[More...]

ARYx Reports First Quarter 2009 Results and Earnings

Thu, 14 May 2009 11:53:00 GMT

ARYx Therapeutics, Inc. (NASDAQ:ARYX) today reported results of operations and provided an update on its products for the first quarter ended March 31, 2009.
In March, ARYx received written confirmation from the Food and Drug Administration (FDA) of its review of results from ARYx's Thorough QT (TQT) study of the company's oral prokinetic agent, ATI-7505.
A presentation discussing the previously disclosed results of the Phase 2b budiodarone clinical trial will occur tomorrow, May 15, 2009, at the Heart Rhythm Society meeting in Boston.

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ARYx Therapeutics Schedules First Quarter 2009 Results and Earnings Call

Thu, 07 May 2009 11:27:00 GMT

ARYx Therapeutics Inc (NASDAQ:ARYX), a biopharmaceutical company, announced today that a conference call to discuss first quarter 2009 results will be held on Thursday, May 14, 2009 at 8:00 a.m. Pacific Time.[More...]

ARYx Reports Fourth Quarter and Full Year 2008 Results of Operations

Thu, 26 Mar 2009 11:00:00 GMT

ARYx Therapeutics, Inc. (NASDAQ:ARYX) today reported results of operations and provided an update on its products for the fourth quarter and year ended December 31, 2008.[More...]

ARYx Therapeutics Schedules Fourth Quarter and Year End 2008 Results and Earnings Call

Thu, 19 Mar 2009 10:59:00 GMT

ARYx Therapeutics, Inc. (NASDAQ:ARYX), a biopharmaceutical company, announced today that a conference call to discuss fourth quarter and year end 2008 results will be held on Thursday, March 26, 2009 at 8:00 a.m. Pacific Time.[More...]

ARYx to Present at the Cowen and Company 29th Annual Healthcare Conference

Fri, 13 Mar 2009 10:57:00 GMT

ARYx Therapeutics, Inc. (NASDAQ:ARYX) today announced that it will present at the Cowen and Company 29th Annual Healthcare Conference Monday, March 16 at 4:40 p.m. Eastern Time. A live webcast of the presentation may be accessed at the ARYx website http://www.aryx.com. The presentation will be archived for 90 days.[More...]