Bioniche Life Scienc (BNHLF) 0.0561 $BNHLF
Telesta Therapeutics Publishes its Q3, 2016 Financial Statements and Provides Corporate Updates
CNW Group - Tue May 10, 6:00AM CDT
(Canadian dollars, except where noted)
TST.TO: 0.07 (unch)
Telesta Announces Type A Meeting Results and Strategic Option Review
PR Newswire - Mon Apr 18, 6:00AM CDT
Telesta Therapeutics Inc. (Telesta) today announced the outcome of its Type A meeting with the U.S. Food and Drug Administration (FDA), which was held via teleconference on Friday, April 15th. Telesta's questions for this meeting were centered on whether the FDA would permit Telesta to resubmit their BLA for MCNA1 under Accelerated Approval, with a more restricted label. Based on their review of Telesta's regulatory filing and the additional information provided by Telesta in the briefing package prepared for the Type A meeting, the FDA has ruled that any potential commercial approval of MCNA would require an additional Phase 3 clinical trial to be completed prior to resubmission of the MCNA BLA.
TST.TO: 0.07 (unch)
Telesta Therapeutics Corporate Update - Type A Meeting with the FDA Scheduled
PR Newswire - Tue Apr 12, 3:30PM CDT
Telesta Therapeutics Inc. (TSX: TST) (PNK: BNHLF) today announced that a Type A meeting has been scheduled with the U.S. Food and Drug Administration (FDA) on Friday, April 15, 2016. This Type A meeting will be focused on the FDA's responses to Telesta's questions concerning the regulatory pathway forward for approval of MCNA1 in the United States.
TST.TO: 0.07 (unch)
Telesta Therapeutics Provides Corporate Update
CNW Group - Wed Mar 09, 6:00AM CST
Telesta Therapeutics Inc. (TSX:TST)(PNK:BNHLF) today announced that it has submitted a request to meet with the U.S. Food and Drug Administration (FDA). This "Type A" meeting request includes specific questions concerning the regulatory path forward for Telesta's therapeutic MCNA(1) in the United States. Telesta expects, based on FDA guidance, that the meeting or teleconference (at the FDA's discretion) will be held within 30 calendar days. Telesta's objective is to obtain clarity on what the FDA will require to consider commercial approval of MCNA for high-risk non-muscle invasive bladder cancer patients who have failed front-line BCG therapy.
TST.TO: 0.07 (unch)
IIROC Trade Resumption - Telesta Therapeutics Inc.
Newsfile Corp - Tue Feb 02, 11:15AM CST
Trading resumes in:
IIROC Trade Resumption - TST
CNW Group - Tue Feb 02, 11:15AM CST
Trading resumes in:
TST.TO: 0.07 (unch)
Telesta Therapeutics Receives Complete Response Letter from FDA
PR Newswire - Tue Feb 02, 11:01AM CST
Telesta Therapeutics Inc. (TSX:TST) (PNK:BNHLF) today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter to Telesta's Biologics License Application (BLA) for MCNA1. In this letter, the FDA communicated that an additional Phase 3 clinical trial for MCNA would be necessary to adequately establish MCNA's efficacy and safety. The FDA also encouraged Telesta to meet with them to discuss further clinical development of MCNA.
TST.TO: 0.07 (unch)
IIROC Trade Halt - Telesta Therapeutics Inc.
Newsfile Corp - Tue Feb 02, 7:28AM CST
The following issues have been halted by IIROC:
Telesta Therapeutics Corporate Update
PR Newswire Europe - Mon Dec 14, 6:02AM CST
MONTREAL, December 14, 2015 /PRNewswire/ --
TST.TO: 0.07 (unch)
Non Muscle Invasive Bladder Cancer (NMIBC) (Superficial Bladder Cancer) - Pipeline Review, H2 2015 - 15 Companies & 21 Drug Profiles
M2 - Mon Dec 07, 6:52AM CST
Research and Markets (http://www.researchandmarkets.com/research/s7bjp9/non_muscle) has announced the addition of the "Non Muscle Invasive Bladder Cancer (NMIBC) (Superficial Bladder Cancer) - Pipeline Review, H2 2015" report to their offering. This report provides comprehensive information on the therapeutic development for Non Muscle Invasive Bladder Cancer (NMIBC) (Superficial Bladder Cancer), complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. It also reviews key players involved in the therapeutic development for Non Muscle Invasive Bladder Cancer (NMIBC) (Superficial Bladder Cancer) and special features on late-stage and discontinued projects. The report enhances decision making capabilities and help to create effective counter strategies to gain competitive advantage. It strengthens R&D pipelines by identifying new targets and MOAs to produce first-in-class and best-in-class products. Companies Involved in Therapeutics Development - Altor BioScience Corporation - APIM Therapeutics AS - Astellas Pharma Inc. - Bavarian Nordic A/S - BioCancell Ltd - Celgene Corporation - Cold Genesys, Inc. - Heat Biologics, Inc. - Spectrum Pharmaceuticals, Inc. - TARIS BioMedical, Inc. - Telesta Therapeutics Inc. - Telormedix SA - Vakzine Projekt Management GmbH - Viralytics Ltd. - Viventia Biotechnologies Inc. Drug Profiles - ALT-801 - ALT-803 - apaziquone - APL-1202 - ATX-101 - BC-819 - Biologic for Superficial Bladder Cancer - CG-0070 - CV-301 - CVA-21 - DAB-389EGF - docetaxel - Drug for NMIBC - erlotinib hydrochloride - imiquimod - lenalidomide - mitomycin SR - Monoclonal Antibody to Inhibit EGFR for Superficial Bladder Cancer - oportuzumab monatox - rAd-IFN - sirolimus albumin-bound - TD-210 - Urocidin - vesigenurtucel-L - VPM-1002 For more information visit http://www.researchandmarkets.com/research/s7bjp9/non_muscle
HTBX: 0.71 (-0.01), SPPI: 6.87 (+0.05), CELGZ: 1.16 (-0.01)
Telesta Therapeutics Announces Results of the FDA Advisory Committee Vote
PR Newswire Europe - Thu Nov 19, 6:02AM CST
MONTREAL, Quebec, November 19, 2015 /PRNewswire/ --
TST.TO: 0.07 (unch)
Telesta Therapeutics Publishes its Q3, 2016 Financial Statements and Provides Corporate Updates
CNW Group - Tue May 10, 6:00AM CDT
(Canadian dollars, except where noted)
TST.TO: 0.07 (unch)
Telesta Announces Type A Meeting Results and Strategic Option Review
PR Newswire - Mon Apr 18, 6:00AM CDT
Telesta Therapeutics Inc. (Telesta) today announced the outcome of its Type A meeting with the U.S. Food and Drug Administration (FDA), which was held via teleconference on Friday, April 15th. Telesta's questions for this meeting were centered on whether the FDA would permit Telesta to resubmit their BLA for MCNA1 under Accelerated Approval, with a more restricted label. Based on their review of Telesta's regulatory filing and the additional information provided by Telesta in the briefing package prepared for the Type A meeting, the FDA has ruled that any potential commercial approval of MCNA would require an additional Phase 3 clinical trial to be completed prior to resubmission of the MCNA BLA.
TST.TO: 0.07 (unch)
Telesta Therapeutics Corporate Update - Type A Meeting with the FDA Scheduled
PR Newswire - Tue Apr 12, 3:30PM CDT
Telesta Therapeutics Inc. (TSX: TST) (PNK: BNHLF) today announced that a Type A meeting has been scheduled with the U.S. Food and Drug Administration (FDA) on Friday, April 15, 2016. This Type A meeting will be focused on the FDA's responses to Telesta's questions concerning the regulatory pathway forward for approval of MCNA1 in the United States.
TST.TO: 0.07 (unch)
Telesta Therapeutics Provides Corporate Update
CNW Group - Wed Mar 09, 6:00AM CST
Telesta Therapeutics Inc. (TSX:TST)(PNK:BNHLF) today announced that it has submitted a request to meet with the U.S. Food and Drug Administration (FDA). This "Type A" meeting request includes specific questions concerning the regulatory path forward for Telesta's therapeutic MCNA(1) in the United States. Telesta expects, based on FDA guidance, that the meeting or teleconference (at the FDA's discretion) will be held within 30 calendar days. Telesta's objective is to obtain clarity on what the FDA will require to consider commercial approval of MCNA for high-risk non-muscle invasive bladder cancer patients who have failed front-line BCG therapy.
TST.TO: 0.07 (unch)
IIROC Trade Resumption - Telesta Therapeutics Inc.
Newsfile Corp - Tue Feb 02, 11:15AM CST
Trading resumes in:
IIROC Trade Resumption - TST
CNW Group - Tue Feb 02, 11:15AM CST
Trading resumes in:
TST.TO: 0.07 (unch)
Telesta Therapeutics Receives Complete Response Letter from FDA
PR Newswire - Tue Feb 02, 11:01AM CST
Telesta Therapeutics Inc. (TSX:TST) (PNK:BNHLF) today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter to Telesta's Biologics License Application (BLA) for MCNA1. In this letter, the FDA communicated that an additional Phase 3 clinical trial for MCNA would be necessary to adequately establish MCNA's efficacy and safety. The FDA also encouraged Telesta to meet with them to discuss further clinical development of MCNA.
TST.TO: 0.07 (unch)
IIROC Trade Halt - Telesta Therapeutics Inc.
Newsfile Corp - Tue Feb 02, 7:28AM CST
The following issues have been halted by IIROC:
Telesta Therapeutics Corporate Update
PR Newswire Europe - Mon Dec 14, 6:02AM CST
MONTREAL, December 14, 2015 /PRNewswire/ --
TST.TO: 0.07 (unch)
Non Muscle Invasive Bladder Cancer (NMIBC) (Superficial Bladder Cancer) - Pipeline Review, H2 2015 - 15 Companies & 21 Drug Profiles
M2 - Mon Dec 07, 6:52AM CST
Research and Markets (http://www.researchandmarkets.com/research/s7bjp9/non_muscle) has announced the addition of the "Non Muscle Invasive Bladder Cancer (NMIBC) (Superficial Bladder Cancer) - Pipeline Review, H2 2015" report to their offering. This report provides comprehensive information on the therapeutic development for Non Muscle Invasive Bladder Cancer (NMIBC) (Superficial Bladder Cancer), complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. It also reviews key players involved in the therapeutic development for Non Muscle Invasive Bladder Cancer (NMIBC) (Superficial Bladder Cancer) and special features on late-stage and discontinued projects. The report enhances decision making capabilities and help to create effective counter strategies to gain competitive advantage. It strengthens R&D pipelines by identifying new targets and MOAs to produce first-in-class and best-in-class products. Companies Involved in Therapeutics Development - Altor BioScience Corporation - APIM Therapeutics AS - Astellas Pharma Inc. - Bavarian Nordic A/S - BioCancell Ltd - Celgene Corporation - Cold Genesys, Inc. - Heat Biologics, Inc. - Spectrum Pharmaceuticals, Inc. - TARIS BioMedical, Inc. - Telesta Therapeutics Inc. - Telormedix SA - Vakzine Projekt Management GmbH - Viralytics Ltd. - Viventia Biotechnologies Inc. Drug Profiles - ALT-801 - ALT-803 - apaziquone - APL-1202 - ATX-101 - BC-819 - Biologic for Superficial Bladder Cancer - CG-0070 - CV-301 - CVA-21 - DAB-389EGF - docetaxel - Drug for NMIBC - erlotinib hydrochloride - imiquimod - lenalidomide - mitomycin SR - Monoclonal Antibody to Inhibit EGFR for Superficial Bladder Cancer - oportuzumab monatox - rAd-IFN - sirolimus albumin-bound - TD-210 - Urocidin - vesigenurtucel-L - VPM-1002 For more information visit http://www.researchandmarkets.com/research/s7bjp9/non_muscle
HTBX: 0.71 (-0.01), SPPI: 6.87 (+0.05), CELGZ: 1.16 (-0.01)
Telesta Therapeutics Announces Results of the FDA Advisory Committee Vote
PR Newswire Europe - Thu Nov 19, 6:02AM CST
MONTREAL, Quebec, November 19, 2015 /PRNewswire/ --
TST.TO: 0.07 (unch)
