Will Astra walk away from roxadustat?
After last month's damning adcom for Fibrogen’s roxadustat today’s complete response letter raises the very real possibility that the group's partner Astrazeneca will choose not to hang around for much longer. For now Astra is keeping the faith, and roxa does have other clinical catalysts on the horizon that Astra might want to see before making a decision. The Whitney phase 2 chemotherapy-induced anaemia trial is due to read out this quarter, but readout of the phase 3 Matterhorn study, in myelodysplastic syndromes, has been delayed from the first half of 2022 to as late as the first half of 2023. Even if Astra does hang around it is unlikely to commit more money to roxa’s US future, which as of today hinges on a whole new clinical study. Fibrogen might have little choice but to trigger a major restructuring to pivot to its next best option, the IPF project pamrevlumab. Roxa still has a chance in Europe, where it received a positive CHMP decision in June. But even if the EMA follows through with approval this will be little consolation to Fibrogen, whose stock has slid 77% in the past six months.