Shares of GTx tumbled early today after the biotech revealed that it had been forced to shutter a trio of clinical trials for its prostate cancer drug hopeful Capesaris after investigators spotted an elevated risk for blood clots among the patients taking the drug. GTx stock ($GTXI) plunged 31% as investors fled on hearing that the FDA had put a clinical hold on its mid-stage studies, throwing up a critical roadblock to its plan to pursue an approval as a frontline treatment.
Memphis-based GTx says its next step will be to sound out the FDA on a change in clinical direction for the treatment, and management raised the possibility of pursuing a lower-dose approach to metastatic hormone sensitive prostate cancer or castration-resistant prostate cancer. In the meantime, GTx CEO Mitchell Steiner resorted to a familiar tactic in the face of clinical adversity: He highlighted the potential of another development program.
"We are pleased with the progress of our clinical development program of enobosarm (the late-stage GTx-024), formerly known as Ostarine," Dr. Steiner said. "Our discussions with lung cancer thought leaders and patient advocates confirm the need for a drug to prevent and treat muscle wasting in patients with advanced non-small cell lung cancer."
GTx--which had benefited from a 73% spike since the beginning of 2012--also reported this morning that the company had lost 17 cents a share in the fourth quarter, in line with Wall Street estimates, according to Dow Jones.
- here's the press release
- get the story from Dow Jones