Why TG Therapeutics (TGTX) Stock Crashed 40% Today

TG Therapeutics (NASDAQ: TGTX) stock price is down nearly 40% today after the company announced the U.S. Food and Drug Administration (FDA) plans to hold a meeting of the Oncologic Drugs Advisory Committee (ODAC).

The Committee will discuss and review pending TGTX’s application for the combination of ublituximab and UKONIQ (umbralisib) (known as U2) for the treatment of adult patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).

“We appreciate the FDA’s efforts in reviewing the U2 BLA/sNDA and its interest in obtaining the perspective of the ODAC regarding the benefit-risk of UKONIQ and the U2 combination. We believe UKONIQ is a unique PI3K inhibitor, with a differentiated toxicity and tolerability profile and believe the data submitted thus far are supportive of approval of U2 in CLL,” said Michael Weiss, Chairman and Chief Executive Officer of TG Therapeutics.

Investors are skeptical about the UKONIQ and the U2 combination as ODAC meetings are usually related to the safety and effectiveness of marketed and investigational human drug products. The committee will make a recommendation to the Commissioner of Food and Drugs.

FDA has concerns about an early analysis of overall survival from the UNITY-CLL trial.

“Overall survival was designated as a secondary efficacy outcome in the UNITY-CLL protocol,” the company said in a statement.

TG Therapeutics stock price was hit earlier this month after Goldman Sachs analyst Graig Suvannavejh downgraded shares from Neutral to Sell with a price target of $26.00 (from $33.00).

“We believe that the commercial opportunities for TGTX's assets are limited by incumbent products in the indications the company is pursuing, thereby setting the stage for challenging launches in the near term. Within this context, our revenue estimates are 35% below consensus estimates for 2022-2024 revenue and 25% below the company's 2025 revenue target of $1B,” the analyst said in a note.

TG Therapeutics stock is down 54.2% YTD after closing at $23.36 yesterday.

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