TG Therapeutics trades higher as FDA accepts umbralisib NDA

TG Therapeutics’ (Nasdaq: TGTX) shares closed up 6.98% at $20.38 on Thursday, after the firm said that the US Food and Drug Administration had accepted the New Drug Application (NDA) for umbralisib, an investigational once-daily, oral, dual inhibitor of PI3K-delta and CK1-epsilon, as a treatment for patients with previously-treated marginal zone lymphoma (MZL) who have received at least one prior anti-CD20 based regimen and follicular lymphoma (FL) who have received at least two prior systemic therapies.

The MZL indication, under Breakthrough Therapy designation (BTD), has been accepted for Priority Review and has a Prescription Drug User Fee Act (PDUFA) goal date of February 15, 2021. The FL indication has been accepted for standard review with a PDUFA goal date of June 15, 2021.

The FDA also notified the company that it is not currently planning to hold an advisory committee meeting to discuss this application, which is regarded as a positive signal from the agency.