Crossject has published a short release to comment on its activities.
As we expected, the group confirmed the planning of market approval filings in Europe and the US (FY19 for Zeneo® Sumatriptan, Zeneo® Midazolam, Zeneo® Adrenaline, Zeneo® Hydrocortisone, Zeneo® Naloxone, FY20 for Zeneo® Methotrexate and Zeneo® Terbutaline).
It also confirmed ongoing negotiations for a licensing agreement concerning Zeneo® Sumatriptan in the US with a possible outcome by mid-2018.
The production line for gas generators has been approved from a regulatory standpoint, a necessary step to see the production lines approved and the production ramp-up for the bioequivalence studies.
All in all, this is good news, in particular since the group does not mention any delays compared to what was previously communicated to the market, a reassuring point since this has not always been the case in the past. For those who have been patient, the reward is getting nearer by the day.
We will not change our numbers and opinion on the release.
We will, however, update our model shortly, particularly to take into account the new NTE (Zeneo® Terbutaline) Crossject intends to market. Half-year results are due on 26 September.