Shots:
The EC has approved Zurzuvae (zuranolone) for the treatment of postpartum depression in adults following MHRA’s approval in Aug 2025
Approval was based on P-III (SKYLARK) trial assessing Zurzuvae (50mg) vs PBO in pts with severe postpartum depression
Trial met its 1EP with a significant mean reduction in HAMD-17 total score at Day 15,…
Shots:
The CHMP has recommended Zurzuvae (zuranolone) for the treatment of postpartum depression in adults; EC’s decision is expected in Q3’25
Opinion was based on P-III (SKYLARK) trial assessing Zurzuvae (50mg) vs PBO in pts with severe postpartum depression
Trial met its 1EP with a significant mean reduction in HAMD-17 total score at Day 15,…
Shots:
Supernus to acquire Sage Therapeutics, strengthening its neuropsychiatry product portfolio with Zurzuvae (zuranolone), & a novel CNS discovery platform
As per the deal, Sage’s shareholders will receive $8.5/share in an all-cash transaction totaling ~$561M, along with one non-tradeable CVR of $3.50/share (~$234M) tied to Zurzuvae milestones: $1 each for US sales allocable to Supernus reaching $250M (by…
Shots:
The US FDA approved 10 NDAs and 3 BLA in August 2023, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 89 novel products in 2023
In August 2023, the major highlights drugs were Zurzuvae (zuranolone) approval for women with postpartum depression and Veopoz (pozelimab-bbfg) for children…

