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Mi, 1. Dezember 2021, 16:44 Uhr

Magforce

WKN: A0HGQF / ISIN: DE000A0HGQF5

Original-Research: MagForce AG (von GBC AG): Buy


18.10.21 10:02
dpa-AFX

^



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


research@gbc-ag.de


++++++++++++++++


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.



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