Roth Capital affirms TG Therapeutics (Nasdaq: TGTX) at Buy with a price target of $25 following Q3 results. TGTX posted Q3 loss of $0.51 per share, versus the firm's estimate looking for a loss of $0.32 per share.

Analyst Joseph Pantginis commented, Over the last 12 months, TG has transformed itself with what we consider to be striking clinical data to a pivotal stage company. The company is within weeks of starting its first Phase III study combining TG-1101 and Pharmacyclics' (PCYC-Buy) Imbruvica. The study will be a randomized controlled study with two arms, '1101+Imbruvica vs. Imbruvica alone. Patients will be previously treated high-risk CLL patients with at least one high-risk cytogenetic abnormality. Recall the primary endpoint, under SPA, will be ORR supporting the filing for Accelerated Approval. The secondary endpoint of PFS is geared toward supporting full approval following longer term patient followup. The study is expected to enroll ~330 patients. As we move into 2015, we expect additional visibility regarding new pivotal studies for TG-1101 and TGR-1202.

Recall our prior highlighting of TG's anticipated costs for each Phase III. The '1101/Imbruvica combo Phase III is expected to cost ~$15 million or less, which we believe represents significant efficiency relative to other Phase III oncology studies of this size. Interestingly, there has been some prior preclinical research suggesting that Imbruvica (through its B-cell mechanism of action) could antagonize ADCC activity. While this may have been a concern, we believe the robust clinical data seen to date with '1101 and Imbruvica, negate these "test tube" observations. Lastly, we anticipate a strong showing at the upcoming ASH conference.

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TG Therapeutics closed at $12.55 yesterday.