Endo

EDAP Announces Third Quarter 2023 Financial Results

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Thursday, November 9, 2023
University of Zurich, AAGL, Hospital, EUR, USD, Overalls, Cleveland Clinic, International Symposium on Endovascular Therapy, Operating cost, EDT, Teaching hospital, University of Florida, Icahn School of Medicine at Mount Sinai, EDAP, League of European Research Universities, Prostate cancer, DACH, League, Marketing, Immunotherapy, University, Investment, Patient, TMS, Congress, Conference, Endo, Research, Growth, SEP, European Society of Gynaecological Oncology, Total, Poster, Lithotripsy, Mount Sinai Hospital, Randomized controlled trial, Pharmaceutical industry, Medical imaging, Film industry, Video game, Lithium, Medicine, Distribution, Urology

- Strong Q3 2023 U.S. Focal One® HIFU procedure growth of +150% year-over-year -

Key Points: 
  • - Strong Q3 2023 U.S. Focal One® HIFU procedure growth of +150% year-over-year -
    - Announces immunotherapy clinical research collaboration with Mount Sinai, Department of Urology -
    - Company to host conference call and webcast today, Thursday, November 9th at 8:30 am EDT -
    LYON, France, November 9, 2023 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, reported today unaudited financial results for the third quarter ending September 30, 2023.
  • The decrease was driven by 1 Focal One system sold in the third quarter 2023 versus 3 systems sold in the third quarter of 2022.
  • Operating loss for the third quarter of 2023 was EUR 5.6 million (USD 6.0 million), compared to an operating loss of EUR 2.1 million (USD 2.2 million) in the third quarter of 2022.
  • A conference call and webcast to discuss the third quarter 2023 financial results will be hosted Ryan Rhodes, Chief Executive Officer, François Dietsch, Chief Financial Officer and Ken Mobeck, Chief Financial Officer of the U.S. subsidiary, today, Thursday, November 9th, 2023, at 8:30am EDT.

Endo Launches Colchicine Capsules, Generic Version of MITIGARE®

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Thursday, November 2, 2023
Aplastic anemia, Patient, Abdominal pain, Clarithromycin, Food, Fatal, Thrombocytopenia, Vomiting, Diarrhea, OTC, Colchicine, Endo, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Nausea, Bone marrow suppression, Endo International, Senior, Ciclosporin, Rhabdomyolysis, Risk, Capsule, Leukopenia, Pancytopenia, Safety, Pain, Granulocyte, Death, Pharmaceutical industry, Dairy, Dietary supplement, CYP3A4

DUBLIN, Nov. 2, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that one of its operating companies, Par Pharmaceutical, Inc., has begun shipping colchicine 0.6 mg capsules, a generic version of Hikma's MITIGARE®.

Key Points: 
  • DUBLIN, Nov. 2, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that one of its operating companies, Par Pharmaceutical, Inc., has begun shipping colchicine 0.6 mg capsules, a generic version of Hikma's MITIGARE®.
  • This is the first generic colchicine capsule approved by the U.S. Food and Drug Administration.
  • Patients with renal or hepatic impairment should not be given colchicine with drugs that inhibit both P-glycoprotein and CYP3A4 inhibitors.
  • Combining these dual inhibitors with colchicine in patients with renal or hepatic impairment has resulted in life-threatening or fatal colchicine toxicity.

Endo Launches Colchicine Capsules, Generic Version of MITIGARE®

Retrieved on: 
Thursday, November 2, 2023
Aplastic anemia, Patient, Abdominal pain, Clarithromycin, Food, Fatal, Thrombocytopenia, Vomiting, Diarrhea, OTC, Colchicine, Endo, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Nausea, Bone marrow suppression, Endo International, Senior, Ciclosporin, Rhabdomyolysis, Risk, Capsule, Leukopenia, Pancytopenia, Safety, Pain, Granulocyte, Death, Pharmaceutical industry, Dairy, Dietary supplement, CYP3A4

DUBLIN, Nov. 2, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that one of its operating companies, Par Pharmaceutical, Inc., has begun shipping colchicine 0.6 mg capsules, a generic version of Hikma's MITIGARE®.

Key Points: 
  • DUBLIN, Nov. 2, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that one of its operating companies, Par Pharmaceutical, Inc., has begun shipping colchicine 0.6 mg capsules, a generic version of Hikma's MITIGARE®.
  • This is the first generic colchicine capsule approved by the U.S. Food and Drug Administration.
  • Patients with renal or hepatic impairment should not be given colchicine with drugs that inhibit both P-glycoprotein and CYP3A4 inhibitors.
  • Combining these dual inhibitors with colchicine in patients with renal or hepatic impairment has resulted in life-threatening or fatal colchicine toxicity.

Endo Presents New Data at the American Orthopaedic Foot & Ankle Society Annual Meeting

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Thursday, September 21, 2023
Hardness, Database, American Orthopaedic Foot and Ankle Society, Endo International, Collagenase clostridium histolyticum, Trial of the century, CCH, MD, Entamoeba histolytica, Randomness, OTC, Knowledge, Endo, Fibromatosis, Safety, Pharmaceutical industry, Patient

DUBLIN, Sept. 21, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that data from clinical studies of collagenase clostridium histolyticum (CCH) in patients with plantar fibromatosis will be presented during the American Orthopaedic Foot & Ankle Society's (AOFAS) annual scientific meeting.

Key Points: 
  • DUBLIN, Sept. 21, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that data from clinical studies of collagenase clostridium histolyticum (CCH) in patients with plantar fibromatosis will be presented during the American Orthopaedic Foot & Ankle Society's (AOFAS) annual scientific meeting.
  • Three presentations cover data from the Phase 1 clinical study of CCH in patients with plantar fibromatosis.
  • "We look forward to presenting our clinical study data as we explore a potential nonsurgical option in patients with plantar fibromatosis."
  • Endo has completed a Phase 2 study and anticipates that the pivotal Phase 3 program will begin later this year.

Endo Presents New Data at the American Orthopaedic Foot & Ankle Society Annual Meeting

Retrieved on: 
Thursday, September 21, 2023
Hardness, Database, American Orthopaedic Foot and Ankle Society, Endo International, Collagenase clostridium histolyticum, Trial of the century, CCH, MD, Entamoeba histolytica, Randomness, OTC, Knowledge, Endo, Fibromatosis, Safety, Pharmaceutical industry, Patient

DUBLIN, Sept. 21, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that data from clinical studies of collagenase clostridium histolyticum (CCH) in patients with plantar fibromatosis will be presented during the American Orthopaedic Foot & Ankle Society's (AOFAS) annual scientific meeting.

Key Points: 
  • DUBLIN, Sept. 21, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that data from clinical studies of collagenase clostridium histolyticum (CCH) in patients with plantar fibromatosis will be presented during the American Orthopaedic Foot & Ankle Society's (AOFAS) annual scientific meeting.
  • Three presentations cover data from the Phase 1 clinical study of CCH in patients with plantar fibromatosis.
  • "We look forward to presenting our clinical study data as we explore a potential nonsurgical option in patients with plantar fibromatosis."
  • Endo has completed a Phase 2 study and anticipates that the pivotal Phase 3 program will begin later this year.

Endo Launches Bivalirudin Injection in Ready-to-Use Vials

Retrieved on: 
Tuesday, July 18, 2023
Percutaneous coronary intervention, Bleeding, Senior, Workflow, Endo International, PTCA, Chest pain, PCI, Warfarin, Kidney, Hospital, Heparin-induced thrombocytopenia, Patient, Risk, OTC, Endo, Health, RTU, Heparin, Pharmaceutical industry, Birth control

"With ready-to-use products like bivalirudin, we're helping to deliver solutions that reduce complexity for healthcare providers—so they can focus on patient care."

Key Points: 
  • "With ready-to-use products like bivalirudin, we're helping to deliver solutions that reduce complexity for healthcare providers—so they can focus on patient care."
  • In May 2023, Endo executed agreements with MAIA Pharmaceuticals, Inc. and Gland Pharma Limited, India to commercialize ready-to-use bivalirudin in the U.S.
  • The infusion dose of bivalirudin injection may need to be reduced, and anticoagulant status monitored in patients with renal impairment.
  • Bivalirudin injection is indicated for use as an anticoagulant in patients undergoing PCI, including patients with heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis syndrome.

Endo Launches Bivalirudin Injection in Ready-to-Use Vials

Retrieved on: 
Tuesday, July 18, 2023
Percutaneous coronary intervention, Bleeding, Senior, Workflow, Endo International, PTCA, Chest pain, PCI, Warfarin, Kidney, Hospital, Heparin-induced thrombocytopenia, Patient, Risk, OTC, Endo, Health, RTU, Heparin, Pharmaceutical industry, Birth control

"With ready-to-use products like bivalirudin, we're helping to deliver solutions that reduce complexity for healthcare providers—so they can focus on patient care."

Key Points: 
  • "With ready-to-use products like bivalirudin, we're helping to deliver solutions that reduce complexity for healthcare providers—so they can focus on patient care."
  • In May 2023, Endo executed agreements with MAIA Pharmaceuticals, Inc. and Gland Pharma Limited, India to commercialize ready-to-use bivalirudin in the U.S.
  • The infusion dose of bivalirudin injection may need to be reduced, and anticoagulant status monitored in patients with renal impairment.
  • Bivalirudin injection is indicated for use as an anticoagulant in patients undergoing PCI, including patients with heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis syndrome.

Endo Presents New Data at the American Podiatric Medical Association Annual Meeting

Retrieved on: 
Thursday, July 13, 2023
Hardness, American Podiatric Medical Association, Endo International, Anatomical terms of location, Collagenase clostridium histolyticum, Trial of the century, CCH, Patient, Randomness, OTC, APMA, Endo, Fibromatosis, Safety, Pharmaceutical industry

DUBLIN, July 13, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that new data from a Phase 1 study of collagenase clostridium histolyticum (CCH) in patients with plantar fibromatosis will be presented during the American Podiatric Medical Association's (APMA) annual scientific meeting.

Key Points: 
  • DUBLIN, July 13, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that new data from a Phase 1 study of collagenase clostridium histolyticum (CCH) in patients with plantar fibromatosis will be presented during the American Podiatric Medical Association's (APMA) annual scientific meeting.
  • The meeting is taking place now through July 16 in Nashville, Tenn.
  • Results from the Phase 1 clinical study showed improvement in nodule hardness and in patient and physician satisfaction scores.
  • Endo has completed Phase 2 and anticipates that the pivotal Phase 3 program will begin later this year.

Endo Presents New Data at the American Podiatric Medical Association Annual Meeting

Retrieved on: 
Thursday, July 13, 2023
Hardness, American Podiatric Medical Association, Endo International, Anatomical terms of location, Collagenase clostridium histolyticum, Trial of the century, CCH, Patient, Randomness, OTC, APMA, Endo, Fibromatosis, Safety, Pharmaceutical industry

DUBLIN, July 13, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that new data from a Phase 1 study of collagenase clostridium histolyticum (CCH) in patients with plantar fibromatosis will be presented during the American Podiatric Medical Association's (APMA) annual scientific meeting.

Key Points: 
  • DUBLIN, July 13, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that new data from a Phase 1 study of collagenase clostridium histolyticum (CCH) in patients with plantar fibromatosis will be presented during the American Podiatric Medical Association's (APMA) annual scientific meeting.
  • The meeting is taking place now through July 16 in Nashville, Tenn.
  • Results from the Phase 1 clinical study showed improvement in nodule hardness and in patient and physician satisfaction scores.
  • Endo has completed Phase 2 and anticipates that the pivotal Phase 3 program will begin later this year.

Endo Announces Approval of XCOPRI™ (cenobamate tablets) in Canada

Retrieved on: 
Thursday, June 29, 2023
Knight Therapeutics, Epilepsy, Seizure, Endo, Health Canada, Corona Labs Inc., OTC, Endo International, Pharmaceutical industry, Paladin

DUBLIN and MONTREAL, June 29, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that Paladin Labs Inc., an Endo operating company, received Health Canada's approval of XCOPRI™ (cenobamate tablets) for adjunctive therapy in the management of partial-onset seizures in adults with epilepsy who are not satisfactorily controlled with conventional therapy.

Key Points: 
  • DUBLIN and MONTREAL, June 29, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that Paladin Labs Inc., an Endo operating company, received Health Canada's approval of XCOPRI™ (cenobamate tablets) for adjunctive therapy in the management of partial-onset seizures in adults with epilepsy who are not satisfactorily controlled with conventional therapy.
  • "Many adults with partial-onset seizures are not able to control their seizures, even with the availability of many anti-seizure medications," said Livio Di Francesco, Vice President & General Manager of Paladin Labs Inc. "Paladin is dedicated to addressing unmet medical needs, and we are proud to achieve this approval—a milestone in epilepsy treatment."
  • Paladin Labs expects to launch XCOPRI™ in December 2023.