J.P. Morgan Maintains Neutral Rating On SGEN

This morning, Seattle Genetics Inc. (NASDAQ: SGEN) announced that the FDA has accepted two Biologics License Application (BLA) filings for SGN-35/B, J.P. Morgan reports.

“Vedotin (BV) as a treatment for relapse/refractory Hodgkin lymphoma and anaplastic large cell lymphoma (ALCL),” J.P. Morgan writes. “This development is very much in line with expectations given the special protocol assessment (SPA) for the Hodgkin indication and the unmet medical need. Indeed the only surprise is that the FDA split the initial single BLA into two separate filings.

“The PDUFA (action) date for both BLAs is Aug 30th, and in the interim, we assume an ODAC panel will be convened around midyear (single-arm studies for indications that haven't seen new drugs for some time.) The bottom line is that we and the Street already assume that BV is highly likely to be approved based on the drug's compelling efficacy, unmet medical need in relapse/refractory patients, and special protocol assessment (SPA) for the Hodgkin indication.”

Biologics License Application currently trades at $17.35.