Motif Bio (LON: MTFB)
Motif Bio had high hopes for its Iclaprim treatment for acute bacterial skin and skin structure infections. However, these hopes were severely dented. The result of a meeting with the FDA will be significant to getting back on track and a recovery in the share price.
The complete response letter from the US FDA was received in February. Motif had hoped that this would enable approval of Iclaprim, but the regulator said it could not approve the new drug application (NDA) in its current form. Concerns about liver toxicity were highlighted.
Motif has met with the FDA in order to discuss the points raised by the regulator. By the end of this month or early June, Motif should receive the minutes of the meeting.
This will be key to any decision on how Motif can progress with Iclaprim, if at all. Ideally, the meeting will provide a path to marketing approval for Iclaprim. Ten years of exclusivity in the US is available if approval is gained.
In March, Motif raised £2.7m at 6p a share and this cash funds the company into June. Further cash will be required, and the amount needed, and whether it can be raised, will depend on the minutes.
Positive news from the FDA could make the share price bounce back https://ukinvestormagazine.co.uk/four-announcements-to-watch-out-for-in-may-and-june/