Shares of TG Therapeutics Inc. (NASDAQ: TGTX) gained 14.4% in July, according to data from S&P Global Market Intelligence, despite a lack of positive announcements. It doesn't take much to move a clinical-stage biotech stocks by double-digit percentages, and I'd wager investors digesting developments that took place during the previous month played a role in this price bump.
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In June, TG Therapeutics announced positive results from a pivotal trial with its lead drug candidate plus Imbruvica for the treatment of high-risk chronic lymphocytic leukemia. Adding ublituximab to the star blood-cancer therapy from AbbVie and Johnson & Johnson led to a 78% objective response rate, and drove the disease into complete remission for 7% of patients. None of the patients given Imbruvica plus a placebo experienced a complete remission and just 45% achieved an objective response.
TG Therapeutics also announced impressive results from an early-stage trial testing a three-drug cocktail containing two of its new drug candidates and a well-known chemotherapy among patients with a variety of hard to treat blood cancers. All four patients with relapsed diffuse large B-Cell lymphoma patients showed an objective response to treatment with ublituximab, TGR-1202, and bendamustine, and the triple-threat combo sent two of the patients' disease into complete remission.
Among a recent deluge of new blood cancer drugs, TG Therapeutics' candidates have largely been overlooked. Similarly high complete response rates across a variety of patients with difficult to treat malignancies in the three-way combination study suggests TG Therapeutics is on to something big.
Based on the phase 3 success reported in June, odds are strong that an FDA application for ublituximab in combination with Imbruvica will earn a green light. Management thinks such an approval could lead to between $200 and $500 million in peak annual sales, which would push the shares well above recent prices.
Racking up approvals for ublituximab in combination with TGR-1202 further ahead could eventually lead to a few billion in annual sales for TG Therapeutics. It's still a long way out, and cancer drug development is anything but certain, but this stock has multibagger written all over it.
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