Roluperidone is seeking an indication for monotherapy in negative symptoms associated with schizophrenia. Roluperidone appears to be on track to be first-to-market in this indication.
Phase 2 data was promising and phase 3 aims to mirror it.
Risks to investment include a historically difficult indication in achieving clinical success, 2021 original patent expiration, and future competition.
While Minerva’s story is interesting, additional key developments will be required to earn a “buy” recommendation.
I think what they’re trying to say in this press release is that this drug has finished phase II as mono therapy with positive results but they’re unsure whether to commence a phase III trial as mono therapy due to the expiring of it’s patent for this indication in 2021. They will probably ask for extension of the patent.
Afaik phase III trial as add-on is on track and the results so far are positive also and they still have a long period for a add-on patent.