Potential FDA Controversy Brewing For TG Therapeutics?

TG Therapeutics Inc 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."

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

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