Crossject has udpated the financial community on both its industrial process and the NTE approvals.
On the positive side, the company indicated that the issues in the “PARC” production line in Dijon (tubes “Prêts A Remplir” ready-to-fill tubes) have been fixed and confirmed it had delivered the first tubes to Cenexi. Market approval files in Europe and the US were also confirmed (FY19 for Zeneo® Sumatriptan, Zeneo® Midazolam, Zeneo® Adrenaline, Zeneo® Hydrocortisone, Zeneo® Naloxone, FY20 for Zeneo® Methotrexate and Zeneo® Terbutaline).
On the less positive side, the group also indicated that it is still negotiating an exclusive distribution agreement in the US for Zeneo Sumatriptan (to be signed in H1 18), while it was previously planned to be ready by the 2017 year-end.
This is only a small delay but, of course, the market reacted negatively last Friday. As we have written on in several occasions, delays are not only postponing future cash flows for Crossject but also casting doubts on the future success of the company.
We are not worried at this stage and delays are also a “normal” feature for any new product, but the stock will remain under pressure as long as such announcements are made.