Désillusion pour Graspa dans la LAL - ACHAT - OC 25€ (vs 36€)
La société a décidé de retirer sa demande d’AMM en Europe pour Graspa dans la Leucémie Aigüe Lymphoïde (LAL) afin de s’accorder les délais suffisants pour rassembler des données complémentaires exigées par le CHMP. Le nouveau dossier d’AMM devrait être soumis mi-2017 impliquant un décalage d’approbation de Graspa à fin 2018 vs 2017 préc. Nous ajustons la date d’approbation de Graspa dans la LAL en Europe ainsi qu’aux US anticipant une commercialisation en 2019. Notre valorisation est ainsi abaissée à 25€ vs 36€ préc. Nous maintenons notre recommandation ACHAT car (i) ces exigences du CHMP sont propres à l’étude dans la LAL en Europe, (ii) le newsflow à venir pourrait réanimer le titre après une baisse de -23% hier et (iii) ce décalage ne devrait pas affecter la consommation de trésorerie et la visibilité financière jusqu’à mi-2018.Erytech Pharma is a pharmaceutical company based in France. Co. is primarily engaged in developing cancer therapies that work by starving tumors. Co.'s first product (ERY-ASP), which is in phase III development, provides a therapeutic solution to frail patients with acute leukemia. Co.'s proprietary technology is based on encapsulation of therapeutic molecules into red blood cells. Co. maintains a production unit located in Lyons with "Pharmaceutical Establishment" status. Co. has also signed two distribution partnership agreements with the Orphan Europe-Recordati company and the TEVA group.
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