Market Overview

Potential FDA Controversy Brewing For TG Therapeutics?

Potential FDA Controversy Brewing For TG Therapeutics?

TG Therapeutics Inc (NASDAQ: TGTX), a small-cap biopharmaceutical company focusing on treatments for B-cell malignancies and autoimmune diseases, was initiated with a Buy rating and $23 price target by analysts at Jefferies.

Jefferies' Matthew Andrews commented in a research report on Tuesday, saying while the stock is under-valued based on the long-term prospect of its ublituximab, there are some risk factors from the U.S. Food and Drug Administration that investors should be aware of.

TG Therapeutics' Rating Justified

Andrews noted that top-line ORR for a Phase 3 study (called GENUINE) of ublituximab + Imbruvica in high-risk R/R CLL are robust. However, a key debate surrounding the therapy would be if the FDA approves the therapy under an accelerated approval as the GENUINE was initially under a Special Protocol Assessment protocol but was amended without the FDA's input.

Andrews explained:

    "We note FDA has approved 16 hem/onc drugs (2013-2017) based on single-arm studies with ORR/DOR as primary endpoint (GENUINE was randomized). Further, the 21st Century Cures Act gives FDA legal authority to ease/amend data requirements to speed approvals by considering 'totality of evidence' (e.g., real-world data). These factors and FDA Dr. Pazdur's history of collaboration with industry suggest a higher potential for AA (85 percent probability)."

Bottom line, the analyst acknowledges that "FDA precedent exists for accelerated approval," but the company's "promising" clinical trials highlights the company's "under-appreciated shots on goal."

Related Links:

Physician Views Off-Label Use A 'Double-Edged Sword' For TG Therapeutics

Don't Let Offerings Blindside Your Thesis

Latest Ratings for TGTX

Oct 2020Cantor FitzgeraldMaintainsOverweight
Sep 2020JP MorganInitiates Coverage OnOverweight
Aug 2020HC Wainwright & Co.MaintainsBuy

View More Analyst Ratings for TGTX
View the Latest Analyst Ratings


Related Articles (TGTX)

View Comments and Join the Discussion!

Posted-In: Analyst Color Biotech Long Ideas News FDA Analyst Ratings Trading Ideas General Best of Benzinga

Latest Ratings

View the Latest Analytics Ratings
Don't Miss Any Updates!
News Directly in Your Inbox
Subscribe to:
Benzinga Premarket Activity
Get pre-market outlook, mid-day update and after-market roundup emails in your inbox.
Market in 5 Minutes
Everything you need to know about the market - quick & easy.
Fintech Focus
A daily collection of all things fintech, interesting developments and market updates.
Thank You

Thank you for subscribing! If you have any questions feel free to call us at 1-877-440-ZING or email us at