Ipsen S.A. ADR (IPSEY) 16.4600 $IPSEY
Multimedia Assets Now Available: Ipsen Biopharmaceuticals, Inc. announces FDA approval of Dysport® (abobotulinumtoxinA) for the treatment of lower limb spasticity in pediatric patients aged two and older
PR Newswire - Wed Aug 03, 2:37PM CDT
Ipsen Biopharmaceuticals, Inc., a subsidiary of Ipsen SA (Euronext: IPN; ADR: IPSEY) (Ipsen), today announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental Biologics License Application (sBLA) for Dysport® (abobotulinumtoxinA) for injection for the treatment of lower limb spasticity in pediatric patients two years of age and older. Dysport® is the first and only FDA-approved botulinum toxin for the treatment of pediatric lower limb spasticity. Those treated with Dysport® showed statistically significant improvement in co-primary efficacy assessments: mean change from baseline in Modified Ashworth scale (MAS) in ankle plantar flexor muscle tone and mean Physician's Global Assessment (PGA) response to treatment score at Week 4 and Week 12. A majority of patients in the clinical study were eligible for retreatment between 16 and 22 weeks; however, some had a longer duration of response. This approval is based on a randomized, multicenter, double-blind, placebo-controlled, international Phase III pivotal study in 235 pediatric patients (158 received Dysport® and 77 received placebo) aged 2 to 17 years with lower limb spasticity due to cerebral palsy causing dynamic equinus foot deformity.
Ipsen Biopharmaceuticals, Inc. announces FDA approval of Dysport® (abobotulinumtoxinA) for the treatment of lower limb spasticity in pediatric patients aged two and older
PR Newswire - Mon Aug 01, 7:00AM CDT
Ipsen Biopharmaceuticals, Inc., a subsidiary of Ipsen SA (Euronext: IPN; ADR: IPSEY) (Ipsen), today announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental Biologics License Application (sBLA) for Dysport® (abobotulinumtoxinA) for injection for the treatment of lower limb spasticity in pediatric patients two years of age and older. Dysport® is the first and only FDA-approved botulinum toxin for the treatment of pediatric lower limb spasticity. Those treated with Dysport® showed statistically significant improvement in co-primary efficacy assessments: mean change from baseline in Modified Ashworth scale (MAS) in ankle plantar flexor muscle tone and mean Physician's Global Assessment (PGA) response to treatment score at Week 4 and Week 12. A majority of patients in the clinical study were eligible for retreatment between 16 and 22 weeks; however, some had a longer duration of response. This approval is based on a randomized, multicenter, double-blind, placebo-controlled, international Phase III pivotal study in 235 pediatric patients (158 received Dysport® and 77 received placebo) aged 2 to 17 years with lower limb spasticity due to cerebral palsy causing dynamic equinus foot deformity.
Ipsen Announces FDA Approval of Dysport(R) (abobotulinumtoxinA) for Injection for the Treatment of Lower Limb Spasticity in Children Aged Two and Older
BusinessWire - Mon Aug 01, 12:01AM CDT
Regulatory News:
Ipsen's First Half 2016 Results
BusinessWire - Thu Jul 28, 12:01AM CDT
--Core Operating Income up 12.6% fueled by strong top-line growth
Exelixis and Its Partner Ipsen Announce Positive Overall Survival Results from Subgroup Analyses of Phase 3 Trial of CABOMETYX(TM) (cabozantinib) Tablets in Advanced Renal Cell Carcinoma at 2016 ASCO Annual Meeting
BusinessWire - Mon Jun 06, 6:36AM CDT
--ABSTRACT #4557, #4558
EXEL: 11.00 (+0.03)
Exelixis and its partner Ipsen announce phase 3 trial results of CABOMETYX(TM) (cabozantinib) tablets demonstrating significant overall survival benefit for previously treated patients with advanced renal cell carcinoma presented at ASCO
BusinessWire - Sun Jun 05, 6:36AM CDT
--Overall survival and progression-free survival benefits consistent across all subgroups evaluated
EXEL: 11.00 (+0.03)
Ipsen's partner Exelixis announced results from randomized phase 2 trial CABOSUN that demonstrate that cabozantinib significantly improved progression-free survival versus sunitinib in previously untreated advanced renal cell carcinoma
BusinessWire - Mon May 23, 1:31PM CDT
Regulatory News:
EXEL: 11.00 (+0.03)
Oncodesign and Ipsen Enter into a Strategic Partnership in Oncology and Oncodesign Joins Ipsen's Paris-Saclay Campus
BusinessWire - Tue May 03, 12:39PM CDT
--Oncodesign teams are moving to Ipsen's private open innovation campus in Paris-Saclay
IPN: 30.07 (-0.12)
Ipsen's First Quarter 2016 Sales
BusinessWire - Thu Apr 28, 12:00AM CDT
--Specialty care sales up 9.7%(1), driven by the accelerated growth of Somatuline(R) in neuroendocrine tumors
Probi and Ipsen Sign Extensive Primary Care Distribution Agreement for Probiotic LP299V(R), Lactobacillus plantarum 299v
BusinessWire - Tue Apr 26, 1:45AM CDT
Regulatory News:
Ipsen is Pleased to Announce That Its Partner Exelixis Obtained FDA Approval of CABOMETYX(TM) (cabozantinib) Tablets for Patients with Advanced Renal Cell Carcinoma Who Have Received Prior Anti-Angiogenic Therapy
BusinessWire - Mon Apr 25, 5:27PM CDT
--In February 2016, Exelixis and Ipsen entered into an exclusive licensing agreement to develop and commercialize cabozantinib in regions outside the United States, Canada and Japan
EXEL: 11.00 (+0.03)
Dassault Systemes and Ipsen sign collaborative agreement to develop innovative programs to support Ipsen's drug discovery
BusinessWire - Tue Apr 05, 12:00AM CDT
Regulatory News:
Ipsen report on voting rights and number of shares
M2 - Tue Feb 09, 6:57AM CST
Ipsen SA (Paris:IPN.PA) on Monday reported that as on 28 January 2016, the total number of shares in the company was 83,245,602.
Ipsen announces publication in Pediatrics of the results of the phase III randomized study showing the efficacy and safety of Dysport(R) (abobotulinumtoxinA) in children with dynamic equinus foot deformity due to cerebral palsy
BusinessWire - Tue Jan 26, 1:14PM CST
Regulatory News:
Ipsen and Galderma Expand Current Distribution Agreement for Dysport(R) in Aesthetic Indications to Some Key Asia-Pacific Territories(1)
BusinessWire - Wed Jan 06, 12:00AM CST
Regulatory News:
Ipsen purchases 20,000 of own shares
M2 - Wed Dec 23, 5:21AM CST
Ipsen SA (Paris :IPN) on Tuesday reported that from 14 December 2015 to 18 December 2015, it has purchased a total of 20,000 of its own shares.
IPN: 30.07 (-0.12)
Ipsen Announces Its Corporate Agenda for 2016
BusinessWire - Thu Dec 17, 12:10PM CST
Regulatory News:
Ipsen reports on share purchase from 30 November to 4 December 2015
M2 - Tue Dec 08, 6:26AM CST
Ipsen SA (Paris:IPN) on Monday reported that during the period from 30 November 2015 to 4 December 2015, it purchased a total of 20,000 of its shares.
IPN: 30.07 (-0.12)
Otonomy Initiates Phase 1 Clinical Trial for Tinnitus Product Candidate, OTO-311
GlobeNewswire - Mon Nov 16, 6:30AM CST
Otonomy, Inc. (Nasdaq:OTIC), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear, today announced the enrollment of the first subjects in a Phase 1 clinical safety trial of OTO-311, a product candidate for the treatment of tinnitus. OTO-311 is a sustained-exposure formulation of the potent and selective N-Methyl-D-Aspartate (NMDA) receptor antagonist gacyclidine. This Phase 1 dose escalation clinical safety study is being conducted in normal healthy volunteers. OTO-311 will be given as a single unilateral intratympanic injection and subjects will be observed for four weeks following dosing.
OTIC: 17.14 (+0.37), IPN: 30.07 (-0.12)
Multimedia Assets Now Available: Ipsen Biopharmaceuticals, Inc. announces FDA approval of Dysport® (abobotulinumtoxinA) for the treatment of lower limb spasticity in pediatric patients aged two and older
PR Newswire - Wed Aug 03, 2:37PM CDT
Ipsen Biopharmaceuticals, Inc., a subsidiary of Ipsen SA (Euronext: IPN; ADR: IPSEY) (Ipsen), today announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental Biologics License Application (sBLA) for Dysport® (abobotulinumtoxinA) for injection for the treatment of lower limb spasticity in pediatric patients two years of age and older. Dysport® is the first and only FDA-approved botulinum toxin for the treatment of pediatric lower limb spasticity. Those treated with Dysport® showed statistically significant improvement in co-primary efficacy assessments: mean change from baseline in Modified Ashworth scale (MAS) in ankle plantar flexor muscle tone and mean Physician's Global Assessment (PGA) response to treatment score at Week 4 and Week 12. A majority of patients in the clinical study were eligible for retreatment between 16 and 22 weeks; however, some had a longer duration of response. This approval is based on a randomized, multicenter, double-blind, placebo-controlled, international Phase III pivotal study in 235 pediatric patients (158 received Dysport® and 77 received placebo) aged 2 to 17 years with lower limb spasticity due to cerebral palsy causing dynamic equinus foot deformity.
Ipsen Biopharmaceuticals, Inc. announces FDA approval of Dysport® (abobotulinumtoxinA) for the treatment of lower limb spasticity in pediatric patients aged two and older
PR Newswire - Mon Aug 01, 7:00AM CDT
Ipsen Biopharmaceuticals, Inc., a subsidiary of Ipsen SA (Euronext: IPN; ADR: IPSEY) (Ipsen), today announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental Biologics License Application (sBLA) for Dysport® (abobotulinumtoxinA) for injection for the treatment of lower limb spasticity in pediatric patients two years of age and older. Dysport® is the first and only FDA-approved botulinum toxin for the treatment of pediatric lower limb spasticity. Those treated with Dysport® showed statistically significant improvement in co-primary efficacy assessments: mean change from baseline in Modified Ashworth scale (MAS) in ankle plantar flexor muscle tone and mean Physician's Global Assessment (PGA) response to treatment score at Week 4 and Week 12. A majority of patients in the clinical study were eligible for retreatment between 16 and 22 weeks; however, some had a longer duration of response. This approval is based on a randomized, multicenter, double-blind, placebo-controlled, international Phase III pivotal study in 235 pediatric patients (158 received Dysport® and 77 received placebo) aged 2 to 17 years with lower limb spasticity due to cerebral palsy causing dynamic equinus foot deformity.
Ipsen Announces FDA Approval of Dysport(R) (abobotulinumtoxinA) for Injection for the Treatment of Lower Limb Spasticity in Children Aged Two and Older
BusinessWire - Mon Aug 01, 12:01AM CDT
Regulatory News:
Ipsen's First Half 2016 Results
BusinessWire - Thu Jul 28, 12:01AM CDT
--Core Operating Income up 12.6% fueled by strong top-line growth
Exelixis and Its Partner Ipsen Announce Positive Overall Survival Results from Subgroup Analyses of Phase 3 Trial of CABOMETYX(TM) (cabozantinib) Tablets in Advanced Renal Cell Carcinoma at 2016 ASCO Annual Meeting
BusinessWire - Mon Jun 06, 6:36AM CDT
--ABSTRACT #4557, #4558
EXEL: 11.00 (+0.03)
Exelixis and its partner Ipsen announce phase 3 trial results of CABOMETYX(TM) (cabozantinib) tablets demonstrating significant overall survival benefit for previously treated patients with advanced renal cell carcinoma presented at ASCO
BusinessWire - Sun Jun 05, 6:36AM CDT
--Overall survival and progression-free survival benefits consistent across all subgroups evaluated
EXEL: 11.00 (+0.03)
Ipsen's partner Exelixis announced results from randomized phase 2 trial CABOSUN that demonstrate that cabozantinib significantly improved progression-free survival versus sunitinib in previously untreated advanced renal cell carcinoma
BusinessWire - Mon May 23, 1:31PM CDT
Regulatory News:
EXEL: 11.00 (+0.03)
Oncodesign and Ipsen Enter into a Strategic Partnership in Oncology and Oncodesign Joins Ipsen's Paris-Saclay Campus
BusinessWire - Tue May 03, 12:39PM CDT
--Oncodesign teams are moving to Ipsen's private open innovation campus in Paris-Saclay
IPN: 30.07 (-0.12)
Ipsen's First Quarter 2016 Sales
BusinessWire - Thu Apr 28, 12:00AM CDT
--Specialty care sales up 9.7%(1), driven by the accelerated growth of Somatuline(R) in neuroendocrine tumors
Probi and Ipsen Sign Extensive Primary Care Distribution Agreement for Probiotic LP299V(R), Lactobacillus plantarum 299v
BusinessWire - Tue Apr 26, 1:45AM CDT
Regulatory News:
Ipsen is Pleased to Announce That Its Partner Exelixis Obtained FDA Approval of CABOMETYX(TM) (cabozantinib) Tablets for Patients with Advanced Renal Cell Carcinoma Who Have Received Prior Anti-Angiogenic Therapy
BusinessWire - Mon Apr 25, 5:27PM CDT
--In February 2016, Exelixis and Ipsen entered into an exclusive licensing agreement to develop and commercialize cabozantinib in regions outside the United States, Canada and Japan
EXEL: 11.00 (+0.03)
Dassault Systemes and Ipsen sign collaborative agreement to develop innovative programs to support Ipsen's drug discovery
BusinessWire - Tue Apr 05, 12:00AM CDT
Regulatory News:
Ipsen report on voting rights and number of shares
M2 - Tue Feb 09, 6:57AM CST
Ipsen SA (Paris:IPN.PA) on Monday reported that as on 28 January 2016, the total number of shares in the company was 83,245,602.
Ipsen announces publication in Pediatrics of the results of the phase III randomized study showing the efficacy and safety of Dysport(R) (abobotulinumtoxinA) in children with dynamic equinus foot deformity due to cerebral palsy
BusinessWire - Tue Jan 26, 1:14PM CST
Regulatory News:
Ipsen and Galderma Expand Current Distribution Agreement for Dysport(R) in Aesthetic Indications to Some Key Asia-Pacific Territories(1)
BusinessWire - Wed Jan 06, 12:00AM CST
Regulatory News:
Ipsen purchases 20,000 of own shares
M2 - Wed Dec 23, 5:21AM CST
Ipsen SA (Paris :IPN) on Tuesday reported that from 14 December 2015 to 18 December 2015, it has purchased a total of 20,000 of its own shares.
IPN: 30.07 (-0.12)
Ipsen Announces Its Corporate Agenda for 2016
BusinessWire - Thu Dec 17, 12:10PM CST
Regulatory News:
Ipsen reports on share purchase from 30 November to 4 December 2015
M2 - Tue Dec 08, 6:26AM CST
Ipsen SA (Paris:IPN) on Monday reported that during the period from 30 November 2015 to 4 December 2015, it purchased a total of 20,000 of its shares.
IPN: 30.07 (-0.12)
Otonomy Initiates Phase 1 Clinical Trial for Tinnitus Product Candidate, OTO-311
GlobeNewswire - Mon Nov 16, 6:30AM CST
Otonomy, Inc. (Nasdaq:OTIC), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear, today announced the enrollment of the first subjects in a Phase 1 clinical safety trial of OTO-311, a product candidate for the treatment of tinnitus. OTO-311 is a sustained-exposure formulation of the potent and selective N-Methyl-D-Aspartate (NMDA) receptor antagonist gacyclidine. This Phase 1 dose escalation clinical safety study is being conducted in normal healthy volunteers. OTO-311 will be given as a single unilateral intratympanic injection and subjects will be observed for four weeks following dosing.
OTIC: 17.14 (+0.37), IPN: 30.07 (-0.12)
