Hold On TG’s Program Stems From Existing – Not New – Concerns
‘Sub-par’ Disclosure Draws Analyst Finger Wagging
TG expects overall survival hazard ratios to move closer to those of existing CLL drugs. Some analysts called a drop in the company’s shares overblown.
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The company plans to conduct additional analyses of data from ongoing trials that are testing its PI3K inhibitor in combination with rituximab for treating types of indolent B-cell non-Hodgkin’s lymphoma.
Gilead pulls Zydelig’s third-line indications in follicular B-cell lymphoma and small lymphocytic lymphoma due to confirmatory trial enrollment challenges resulting from an evolving treatment landscape; 13 cancer indications now have been withdrawn since the FDA began cracking down on accelerated approvals that have not confirmed clinical benefit.
The latest news about applications under FDA review, from the Pink Sheet’s US FDA Performance Tracker