The long weekend was hardly long enough for TG Therapeutics (TGTX) investors. Shares tumbled 21% in Monday’s session after the company announced it was taking Ukoniq – TG’s approved treatment for patients suffering from relapsed or refractory (r/r) marginal zone lymphoma (MZL) and follicular lymphoma (FL) – off the market.
The decision came on the back of updated data from a Phase 3 study of a combination of ublituximab and Ukoniq (umbralisib) – a combo known as U2 – indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). The new data showed that taking the drug increased the risk of death with the overall survival (OS) tilting in the control arm’s favor rather than the treatment arm. The new set of data differs from the improved OS results which were presented to the FDA in February.
As a result, the company has also decided to withdraw the pending BLA/ sNDA for the combination. Accordingly, the Oncologic Drug Advisory Committee (ODAC) meeting which was slated to take place on April 22 will now be canceled.
Ukoniq is the company’s lone commercial product, and last year was responsible for generating practically all of the company’s revenue
And yet, not everyone has lost faith. B. Riley analyst Mayank Mamtani reiterated his support for TG Therapeutics stock, reminding investors that he still has a “buy” rating on the shares — and a $23 price target that implies TGTX shares could triple in price over the course of the next 12 months. (See Mamtani’s track record, click here)
“While we acknowledge the widely anticipated knee-jerk reaction… we remind investors of our investment thesis centered around the upcoming 9/28/22 PDUFA target action date for ublituximab in relapsing MS; and we view the exit from oncology as a clearing event for what may emerge to be a blockbuster drug in ublituximab supported by a strong balance sheet. As such, stripping out cancer-focused portfolio revenues lower our PT from $35 to $23, partially offset by meaningfully reduced R&D spend over time, and hence supportive of our buy-the-dip call here,” Mamtani explained.
It remains to be seen whether other analysts update their TGTX models shortly, but for now, the Street remains resolutely bullish; all 6 reviews are positive, making the consensus view on this stock a Strong Buy. Moreover, the average price target clocks in at $32.5, suggesting one-year gains of a bountiful 366%. (See TGTX stock forecast on TipRanks)
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Disclaimer: The opinions expressed in this article are solely those of the featured analyst. The content is intended to be used for informational purposes only. It is very important to do your own analysis before making any investment.
