Bioitech company TG Therapeutics Inc. (TGTX, Financial) updated the market about its meeting with the U.S. Food and Drug Administration in regard to TG-1101 (ublituximab) on Oct. 16.Â
The company and the agency discussed the possibility of using the results from the phase III Genuine clinical trial, which assessed the efficacy of the combination of TG-1101and ibrutinib as treatment for patients with chronic lymphocytic leukaemia (CLL), as support for its Biologics License Application (BLA).Â
TG-1101 is an anti-CD20 monoclonal, glycoengineered antibody that targets and binds to the CD20 protein present in tumorous B-cells. This compound enhances the destruction of cancer cells.
The company disclosed the FDA said the accelerated review of the drug based on the Overall Response Rate (ORR) would be "a review issue." The agency also encouraged the company to take into account future available therapy in its risk-benefit analysis.
The company plans to meet with the FDA again to discuss using the trial's progression-free survival (PFS) endpoint to bolster the treatment's approval.Â
TG plans to file its BLA during the second quarter of 2018.
TG Therapeutics is uptrending and has gained 45.4% year to date. The stock closed at $9.27 per share on Monday, down $1.73 or 15.68% from the previous trading day.
The company has a market capitalization of $638.45 million, an enterprise value of $552.55 million and a price-book (P/B) ratio of 8.12.
The company has 68.84 million shares outstanding, of which 59.1% is traded on the Nasdaq. Insiders hold 20.30% of the company's outstanding shares while institutions hold 57.63%.
Disclosure: I have no position in any stock mentioned in this article.
