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Shares of GTx, Inc. (GTXI) plunged to a multi-year low today after the Company announced that it has received a Complete Response Letter issued by the United States FDA regarding its New Drug Application (NDA) for toremifene 80 mg to reduce fractures in men with prostate cancer receiving androgen deprivation therapy (ADT).
The FDA identified two deficiencies in the Complete Response Letter and recommended that the following information be provided to the FDA to address these clinical deficiencies: results of a second adequate and well controlled Phase III trial demonstrating the safety and efficacy of toremifene citrate 80mg to reduce fractures in men with prostate cancer on ADT; and results from an adequate and well-controlled clinical trial demonstrating that toremifene treatment to reduce fractures in men with prostate cancer on ADT does not have a detrimental effect on either time-to-disease progression or overall survival. GTx is requesting a meeting with the FDA to determine the appropriate next steps regarding the NDA.
Dr. Mitchell Steiner, CEO of GTx, commented in a conference call this morning, "This was a big surprise, and it appears as though the FDA has 'moved the goal post.' We never had any discussion with the Agency regarding these issues at any point. In fact, it appears as though this was thrown in at the last minute. We believe that we already have sufficient evidence to satisfy the FDA's request to demonstrate these points. It is important to note that these are the only difficiencies in the Complete Response Letter. There were no other issues raised in the letter including any specific safety issues."
He added, "We will request a meeting with the FDA. It is not productive for us to speculate on the outcome or intentions of the Agency until that meeting."
Dr. Steiner explained, "This is not our only program, and we stand behind our scientific and clinical work in this study. If it turns out that we have to invest more money into this program to see it go forward, then we will have to take a hard look at all of the programs that we are involved in to see what would be most productive."
He concluded, "We hope that in short time that we will be able to characterize this as a just a delay."
Cowen downgraded shares of GTXI today to Underperform from Neutral.
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