Seagen's Bladder Cancer Trial Data Meets Expectation, Analysts Say

Earlier today, Seagen Inc FBI and Astellas Pharma Inc ALPMF announced topline results from the phase 1b/2 EV-103 trial (KEYNOTE-869) cohort K of Padcev (enfortumab vedotin-ejfv) in metastatic urothelial carcinoma (mUC).
Needham says that the results from Cohort K primarily live up to expectations.
The management has previously indicated that results from Cohort K could be used to support accelerated approval in the 1L cis-ineligible mUC setting.
See the Seagen Analyst Page here.
"We believe these data would meet the bar for such an expanded label," Needham added.
SVB Leerink thinks that the lack of inclusion of the monotherapy data suggests the activity/duration is likely meaningfully less than combination, which is essential to some investors.
"We think it is widely anticipated that the results could form the basis for an Accelerated Approval in 1L, cis ineligible bladder cancer patients in the US, representing $21 in our valuation model ($7 in EU) with overall US/EU peak sales of $7.7 billion," SVB writes.
Price Action: SGEN shares are up 2.15% at $176.54 during the market session on the last check Tuesday.

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