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Original-Research: Cardiol Therapeutics Inc - from First Berlin Equity Research GmbH
Classification of First Berlin Equity Research GmbH to Cardiol Therapeutics Inc
First Berlin Equity Research has published a research update on Cardiol Therapeutics Inc. (ISIN: CA14161Y2006). Analyst Christian Orquera reiterated his BUY rating and maintained his USD 8.50 price target. Abstract: Cardiol Therapeutics (Cardiol) announced that the first patient has been enrolled in the pivotal MAVERIC phase III study evaluating its oral drug candidate CardiolRxT for the treatment of recurrent pericarditis (RP), a painful and debilitating heart condition. This is good news as it marks the start of a pivotal phase III trial, an important milestone that brings CardiolRxT closer to potential FDA approval. The study, led by leading cardiovascular experts and initiated at Northwestern University, is a randomised, double-blind, placebo-controlled trial that will enrol 110 patients at 20 sites in the US, Canada and Europe. The drug addresses a clear unmet need in RP with a promising, non-immunosuppressive oral option. Backed by an orphan drug designation and strong phase II data in RP, we believe the programme has a good chance of success in the phase III trial, and we also see significant commercial potential in this indication. If successful, this study will support submission of a new drug application to the FDA. The next significant catalyst will be the headline results of the multi-national, randomised, placebo-controlled ARCHER phase II study in acute myocarditis (AM), which we expect within the next one to two months. We have updated our SOTP valuation model, which yields an unchanged price target of USD 8.50. We reiterate our Buy recommendation. First Berlin Equity Research hat ein Research Update zu Cardiol Therapeutics Inc. (ISIN: CA14161Y2006) veröffentlicht. Analyst Christian Orquera bestätigt seine BUY-Empfehlung und bestätigt sein Kursziel von USD 8,50. Zusammenfassung: Cardiol Therapeutics (Cardiol) gab bekannt, dass der erste Patient in die zulassungsrelevante Phase-III-Studie MAVERIC aufgenommen wurde, in der der orale Arzneimittelkandidat CardiolRxT zur Behandlung von rezidivierender Perikarditis (RP), einer schmerzhaften und schwächenden Herzerkrankung, untersucht wird. Dies ist eine gute Nachricht, denn sie markiert den Beginn einer zulassungsrelevanten Phase-III-Studie, ein wichtiger Meilenstein, der CardiolRxT einer möglichen FDA-Zulassung näher bringt. Bei der von führenden Herz-Kreislauf-Experten geleiteten und an der Northwestern University initiierten Studie handelt es sich um eine randomisierte, doppelblinde, placebokontrollierte Studie, in die 110 Patienten an 20 Standorten in den USA, Kanada und Europa aufgenommen werden sollen. Das Medikament ist eine vielversprechende, nicht-immunsuppressive, orale Option, die einen eindeutigen ungedeckten Bedarf in der RP abdeckt. Gestützt auf den Orphan-Drug-Status und überzeugende Phase-II-Daten bei RP sind wir der Ansicht, dass das Programm gute Erfolgschancen in der Phase-III-Studie hat, und wir sehen auch ein erhebliches kommerzielles Potenzial in dieser Indikation. Bei Erfolg wird diese Studie einen Antrag auf Zulassung als neues Medikament (NDA) bei der FDA unterstützen. Der nächste wichtige Katalysator werden die Hauptergebnisse der multinationalen, randomisierten, placebokontrollierten Phase-II-Studie ARCHER bei akuter Myokarditis (AM) sein, die wir in den nächsten ein bis zwei Monaten erwarten. Wir haben unser SOTP-Bewertungsmodell aktualisiert, das zu einem unveränderten Kursziel von USD 8,50 führt. Wir halten an unserer Kaufempfehlung fest. Bezüglich der Pflichtangaben gem. §85 Abs. 1 S. 1 WpHG und des Haftungsausschlusses siehe die vollständige Analyse. You can download the research here: http://www.more-ir.de/d/32336.pdf Contact for questions: First Berlin Equity Research GmbH Herr Gaurav Tiwari Tel.: +49 (0)30 809 39 686 web: www.firstberlin.com E-Mail: g.tiwari@firstberlin.com
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