Original-Research: MagForce AG - von GBC AG Einstufung von GBC AG zu MagForce AG Unternehmen: MagForce AG ISIN: DE000A0HGQF5 Anlass der Studie: Research Comment Empfehlung: Buy Kursziel: 11.00 EUR Kursziel auf Sicht von: 31.12.2021 Letzte Ratingänderung: Analyst: Cosmin Filker, Marcel Goldmann FDA announces conditions for the final pivotal study; study expected to start in 2021 and to be completed in mid-2022; timeframe largely in line with our expectations; forecasts, price target and BUY rating confirmed According to corporate news of 13.10.2021, MagForce AG has made significant progress in obtaining approval for the treatment of prostate cancer. The US regulatory authority FDA has notified MagForce AG of the conditions for approval of the final clinical protocol. Finally, the company has received the conditions for final approval in the USA. After timely submission of the required documentation to the FDA, the company expects to receive final approval to begin Phase 2b in November 2021. Until the start of Phase 2b, recruitment of the required 100 patients will continue. These patients will be used to confirm the promising results and the very good safety and tolerability profile of Phase 2a, which has already been conducted. The aim of the study is to enable prostate cancer patients to remain stable for a longer period of time without external radiation or surgery. Patients with moderate dysfunction (lesions) could thus return to the so-called 'active surveillance' programme, in which only close observation takes place. Assuming prompt FDA approval, MagForce's management board expects the trial to be completed in the summer of 2022. In the course of the trial, the company will submit interim results to the FDA after treating 15 to 30 patients, so that market approval can also be obtained quickly upon completion of the trial. Should this take place in the second half of 2022, MagForce AG would be in a position to quickly enter the commercialisation phase. This is possible primarily because the treatment centres and personnel required for commercialisation are already in place to carry out the approval study. Accordingly, there is no need to build up the infrastructure. However, it is likely that the current MagForce treatment centres in Texas, Washington and Florida will be joined by additional centres as early as the 2022 financial year, enabling broader regional coverage. Compared to our previous expectation, this results in a slight delay of two to three months. Previously (see research study dated 20 July 2021), we had expected commercialisation to begin in mid-2022, so the current approval schedule is largely in line with our expectations. Since we had assumed only low sales revenues in the prostate segment for the coming 2022 financial year anyway, we currently see no reason to adjust our forecast. With an unchanged price target of EUR11.00, we continue to assign a BUY rating. Die vollständige Analyse können Sie hier downloaden: http://www.more-ir.de/d/22983.pdf Kontakt für Rückfragen GBC AG Halderstraße 27 86150 Augsburg 0821 / 241133 0 firstname.lastname@example.org ++++++++++++++++ Offenlegung möglicher Interessenskonflikte nach § 85 WpHG und Art. 20 MAR. Beim oben analysierten Unternehmen ist folgender möglicher Interessenkonflikt gegeben: (5a,6a,11); Einen Katalog möglicher Interessenkonflikte finden Sie unter: http://www.gbc-ag.de/de/Offenlegung +++++++++++++++ Date (time) of completion: 15/10/2021 (3:04 pm) Date (Time) first distribution: 18/10/2021 (10:00 am) -------------------übermittelt durch die EQS Group AG.------------------- Für den Inhalt der Mitteilung bzw. Research ist alleine der Herausgeber bzw. Ersteller der Studie verantwortlich. Diese Meldung ist keine Anlageberatung oder Aufforderung zum Abschluss bestimmter Börsengeschäfte.