ArQule, Inc. (ARQL) Shares Dive as HCC Trial Fails to Meet Primary Endpoint


ArQule, Inc. (NASDAQ:ARQL) shares tumbled nearly 20% this morning after investors learned that the company’s METIV-HCC phase 3 study of tivantinib in hepatocellular carcinoma (HCC) did not meet its primary endpoint of improving overall survival.

“HCC is a disease with high unmet need, especially in the second-line setting, so these results are disappointing for the patients as well as the investigators and the companies,” said Paolo Pucci, Chief Executive Officer of ArQule.

“Despite the negative outcome of this study, we remain committed to applying rigorous science to unmet needs for patients with cancer,” said Antoine Yver, MD, MSc, Executive Vice President and Global Head, Oncology Research and Development, Daiichi Sankyo. “We would like to take this opportunity to thank all of the investigators, and especially the patients, for their participation in this study.”

Full results from the trial will be presented at an upcoming scientific forum.

On the ratings front, Leerink Swann analyst Michael Schmidt reiterated a Hold rating on ARQL, with a price target of $2.50, in a report issued on November 7. The current price target represents a potential upside of 70% from where the stock is currently trading. According to TipRanks.com, Schmidt has a yearly average return of 30.2%, a 59% success rate, and is ranked #61 out of 4459 analysts.

ArQule, Inc. is a clinical-stage biopharmaceutical company, which engages in the research and development of pharmaceutical products. Its proprietary pipeline is directed towards molecular targets and biological processes with demonstrated roles in the development of human cancers. Its portfolio includes Tivantinib, ARQ 087, ARQ 092, ARQ 761, and ARQ 751. The company was founded in 1993 and is headquartered in Burlington, MA.