- Size:
- —
- Delta:
- No change (84.2% → 84.2%)
Insufficient cash to trade. High approval probability based on strong efficacy data and favorable PBC treatment landscape.
Insufficient cash to trade. High approval probability based on strong efficacy data and favorable PBC treatment landscape.
NDA accepted (PDUFA 3/24/26) based on positive Phase 3 GLISTEN results meeting all key endpoints. Pruritus is a major unmet need; manageable safety and validated mechanism (IBAT) support high approval probability.
Phase 3 data showed a statistically significant improvement in pruritus for patients with PBC, a major unmet need. The safety profile is manageable, making the current YES price attractive. Steady-state cap reduced request to $1000.00.
Strong GLIMMER Ph3 data and unmet need in PBC pruritus support >84% approval odds; positive FDA nod boosts GSK stock valuation. Steady-state cap reduced request to $1000.00.
With no clear new efficacy/safety red flags, approval odds look high, but 83. 9% already prices that in.