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Idorsia Pharmaceuticals Ltd: Idorsia submits NDA for clazosentan to Japanese PMDA


Idorsia Pharmaceuticals Ltd: Idorsia submits NDA for clazosentan to Japanese PMDA
Allschwil, Switzerland - March 1, 2021
Idorsia Ltd (SIX: IDIA) today announced the submission of a New Drug Application (NDA) to the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for clazosentan, a fast-acting, selective endothelin A (ET
A) receptor antagonist, for the prevention of cerebral vasospasm, vasospasm-related cerebral infarction and cerebral ischemic symptoms after aneurysmal subarachnoid hemorrhage (aSAH).
The application is supported by replicated results from the Japanese registration program which consisted of two double-blind, randomized, placebo-controlled studies assessing the efficacy and safety of clazosentan in reducing vasospasm-related morbidity and all-cause mortality events in adult Japanese patients following aSAH. Patients were randomized to receive continuous infusion of either 10 mg/hr clazosentan or placebo for up to 15 days following the ons ....

Switzerland General , Andrewc Weiss , Satoshi Tanaka , Idorsia Ltd , Head Of Investor Relations Corporate Communications , Swiss Exchange , Japanese Pharmaceuticals , Idorsia Pharmaceuticals Ltd , Life Sciences , Idorsia Pharmaceuticals Japan , Devices Agency , New Drug Application , Medical Devices Agency , Cerebrovascular Diseases , Pharmacol Exp Ther , Pharmaceuticals Japan , Vice President , Investor Relations , Pharmaceuticals Ltd , சுவிட்சர்லாந்து ஜநரல் , சதோஷி தனகா , தலை ஆஃப் முதலீட்டாளர் உறவுகள் பெருநிறுவன தகவல்தொடர்புகள் , சுவிஸ் பரிமாற்றம் , ஜப்பானிய மருந்துகள் , வாழ்க்கை அறிவியல் , புதியது மருந்து விண்ணப்பம் ,

Investegate |Schaltbau Holding AG Announcements | Schaltbau Holding AG: Conclusion of a pre-placement agreement and intended subscription offer for mandatory convertible bonds


DGAP-Ad-hoc: Schaltbau Holding AG / Key word(s): Financing
Schaltbau Holding AG: Conclusion of a pre-placement agreement and intended subscription offer for mandatory convertible bonds
01-March-2021 / 19:42 CET/CEST
Disclosure of an inside information acc. to Article 17 MAR of the Regulation (EU) No 596/2014, transmitted by DGAP - a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.
Schaltbau Holding AG: Conclusion of a pre-placement agreement and intended subscription offer for mandatory convertible bonds
Munich, 1 March 2021 - Today, Schaltbau Holding AG [ISIN DE000A2NBTL2] (hereinafter also Schaltbau or Company ) entered into a pre-placement agreement with the investors of the AiC-Group under the leadership of Luxempart, Active Ownership Group, Shareholder Value Management and Teslin Capital Management (manager of the Midlin and Gerlin funds). Under the terms of this agreement, the investors have undertaken ....

United States , Frankfurt Am Main , Federal Republic Of Germany , Kai Holtmann , German Federal Financial Supervisory Authority Bafin , Head Of Investor Relations Corporate Communications , Frankfurt Stock Exchange , Schaltbau Group , Schaltbau Holding , Ownership Group , Schaltbau Or Company , Active Ownership Group , Shareholder Value Management , Teslin Capital Management , Mandatory Convertible Bonds , Frankfurt Stock , German Federal Financial Supervisory Authority , Federal Republic , Securities Act , Prime Standard , Investor Relations , Investegate Announcements , Investegate Company Announcements , Schaltbau Holding Ag , Eqs And , ஒன்றுபட்டது மாநிலங்களில் ,