Shares of Athenex (ATNX) dropped Monday after the drugmaker said that the U.S. Food and Drug Administration raised concern about the safety of its treatment for metastatic breast cancer and urged the company to conduct a new clinical trial.
The FDA issued a complete response letter for the company's new-drug application for oral paclitaxel plus encequidar to treat metastatic breast cancer.
At last check Athenex shares were down 55% to $5.39.
“We are surprised and disappointed by the FDA’s decision to issue a complete response letter for oral paclitaxel and encequidar,” Chief Executive Johnson Lau said in a Monday statement.
“Based on the clinical benefits demonstrated by the Phase III trial results, we are committed to exploring our available options to obtain approval for oral paclitaxel and encequidar."
Athenex said it planned to request a meeting with the FDA to discuss its response.
"We plan to work with the agency to resolve the issues raised in the [complete response letter] and to obtain approval for oral paclitaxel plus encequidar in metastatic breast cancer," Rudolf Kwan, a physician who is chief medical officer at the Buffalo, N.Y., biopharma.
Separately, Athenex reported a loss that widened from a year earlier and missed analyst estimates.
The fourth-quarter net loss widened to 53 cents a share from 28 cents in the year-earlier quarter. Analysts surveyed by FactSet were expecting a loss of 41 cents a share.
Revenue for the quarter was $21.8 million, compared with $34.4 million a year earlier. The latest figure was above the consensus analyst estimate of $20.7 million.