A phase III Lennox-Gastaut trial sees Fintepla meet statistical significance but fail the test of clinical relevance.
Four assets with previous rejections are due FDA decisions in February, while those with priority review could become the next string of early approvals.
Genmab is seeking data to position tisotumab as its first in-house launch, while Zogenix wants Fintepla to challenge GW in Lennox-Gastaut syndrome.
Spending $250m on Modis gives Zogenix a new rare disease niche, but the timing and the target both look odd.
A strong pivotal result should allow the company to broaden Epidiolex’s reach to tuberous sclerosis complex, as long as liver injury risk can be ruled out.
A regulatory misstep puts Zogenix even further behind its epilepsy rival GW Pharma, which in turn is waiting for data that could give it another boost.
Battle in a rare form of epilepsy queued up following positive phase III trial.
Zogenix and Mallinckrodt face investor scrutiny as they report critical data that will answer questions about safety and efficacy.