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Idorsia initiates the Phase 3 registration study with selatogrel for the treatment of acute ...


Press release content from Globe Newswire. The AP news staff was not involved in its creation.
Idorsia initiates the Phase 3 registration study with selatogrel for the treatment of acute .
Idorsia Pharmaceuticals LtdJune 28, 2021 GMT
 
Ad hoc announcement pursuant to Art. 53 LR
Idorsia to host an investor webcast to discuss the Phase 3 study today at 14:30hrs CEST
Allschwil, Switzerland – June 28, 2021
Idorsia Ltd (SIX: IDIA) today announced the initiation of the Phase 3 registration study “SOS-AMI” to evaluate the efficacy and safety of self-administered subcutaneous selatogrel, Idorsia’s P2Y12 receptor antagonist, in suspected acute myocardial infarction (AMI).
An AMI, or heart attack, is a life-threatening condition that occurs when blood flow to the heart muscle (myocardium) is suddenly decreased or completely cut off by a blood clot in one or more of the coronary vessels. An AMI requires immediate treatment, as any delay in intervent ....

Switzerland General , United States , United Kingdom , Harvard University , Boston Latin School , Martine Clozel , Andrewc Weiss , Guy Braunstein , Jean Paul Clozel , Deepakl Bhatt , Mary Mooney , Cardiovascular Coordinating Center , Head Of Investor Relations Corporate Communications , Trinity College Dublin , Head Of Global Clinical Development At Idorsia , European Society Of Cardiology , Hospital Of The University Pennsylvania , Health Research Board , Member Of The Steering Committee , Idorsia Ltd , Steering Committee , Study Group , Us Centers For Disease , Harvard Medical School , Professor Of Medicine At Harvard Medical School , Swiss Exchange ,

Idorsia initiates the Phase 3 registration study with selatogrel for the treatment of acute myocardial infarction


and Chair of the Steering Committee
for SOS-AMI, commented:
P2Y
12 receptor antagonists have been used in the treatment of millions of patients globally, and their safety and efficacy profiles are well established. Despite the success of chronic treatment with this class and other effective interventions, patients are still suffering recurrent heart attacks. The idea for patients to self-inject early in the onset of symptoms is truly innovative. The subcutaneous route of administration could overcome the onset delay observed with oral compounds from the same class.
To be effective, any antithrombotic treatment for use at the onset of AMI symptoms should be rapidly absorbed and potent, acting quickly to inhibit thrombus formation at an early stage. Inhibition should be reversed after a few hours to avoid interfering with later patient management decisions. It must also have an appropriate safety profile for use prior to formal diagnosis of AMI. Selatogrel has the ....

Switzerland General , United States , United Kingdom , Harvard University , Boston Latin School , Martine Clozel , Andrewc Weiss , Coll Cardiol , Guy Braunstein , Jean Paul Clozel , Deepakl Bhatt , Mary Mooney , Cardiovascular Coordinating Center , Head Of Investor Relations Corporate Communications , Trinity College Dublin , United Kingdom Heart Attack Study Collaborative Group , Head Of Global Clinical Development At Idorsia , European Society Of Cardiology , Hospital Of The University Pennsylvania , Health Research Board , A Report From The American Heart Association , Member Of The Steering Committee , Idorsia Ltd , Professor Of Medicine At Harvard Medical School , Steering Committee , Study Group ,

Investegate |Idorsia Pharmaceuticals Ltd Announcements | Idorsia Pharmaceuticals Ltd: Idorsia announces financial results for the first quarter 2021 – substantial progress made across the pipeline – launch preparations well underway


131.3
US GAAP revenue of CHF 7 million in the first quarter of 2021 consisted of contract revenue recognized in connection with the collaboration agreements with Neurocrine Biosciences, Inc. (CHF 1 million), Janssen Biotech, Inc. (CHF 3 million), Roche (CHF 2 million) and Mochida Pharmaceutical Co., Ltd (CHF 1 million) compared to a revenue of CHF 5 million in the first quarter of 2020.
US GAAP operating expenses in the first quarter of 2021 amounted to CHF 129 million (CHF 116 million in the first quarter of 2020), of which CHF 97 million relates to R&D (CHF 97 million in the first quarter of 2020) and CHF 31 million to SG&A expenses (CHF 19 million in the first quarter of 2020). ....

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Idorsia announces financial results for the first quarter 2021 – substantial progress made ...


Press release content from Globe Newswire. The AP news staff was not involved in its creation.
Idorsia announces financial results for the first quarter 2021 – substantial progress made .
Idorsia Pharmaceuticals LtdApril 22, 2021 GMT
Allschwil, Switzerland – April 22, 2021
Idorsia Ltd (SIX: IDIA) today announced its financial results for the first quarter of 2021.
Business highlights
Daridorexant new drug application (NDA) submitted to the US FDA in January 2021 and has been accepted for review
Daridorexant marketing authorisation application (MAA) submitted to the European Medicines Agency (EMA) in March 2021
Daridorexant MAA submitted to Switzerland’s health authority, Swissmedic, in April 2021
Daridorexant Phase 3 program has concluded – supporting the chronic use of daridorexant in insomnia ....

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Investegate |Idorsia Pharmaceuticals Ltd Announcements | Idorsia Pharmaceuticals Ltd: US FDA approves Ponvory (ponesimod) to treat adults with relapsing forms of multiple sclerosis