April will see the US regulator examine Pfizer’s Jak in atopic dermatitis, and experts meet to discuss accelerated approvals in oncology.
Important data releases are on the cards for Rhythm, Wave and Supernus, among others.
The FDA will have a busy November, with decisions due for Bristol, Sanofi and Y-mabs, among others.
Supernus needs something to fill the gap left by its faltering epilepsy drug Trokendi XR, but SPN-810 isn’t it.
A phase III failure will do nothing to help Supernus’s SPN-812 compete against generic ADHD drugs.
Limiting abuse and reducing risks are the differentiating factors for projects from Kempharm and Supernus.