FDA Clears Alpha Tau to Complete Glioblastoma Trial Enrollment, Citing 100% Local Disease Control
DRTS has more than doubled off its 52-week low of $2.85.
Summary
The FDA has cleared Alpha Tau to complete enrollment for the remaining seven patients in its REGAIN recurrent glioblastoma trial and approved two additional U.S. clinical sites. This follows the highly positive interim results announced on May 11, which demonstrated 100% local disease control and a 67% complete response rate in the first three patients. This regulatory green light and expansion accelerate the trial, bringing Alpha DaRT closer to potential market approval for a devastating cancer with high unmet need. The strong early data, coupled with FDA's prior Breakthrough Device Designation and inclusion in the TAP program, significantly de-risk the development path. Completion of enrollment and subsequent full trial results will be key.
At the time of this announcement, DRTS was trading at $9.35 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $813.2M. The 52-week trading range was $2.85 to $11.62. This news item was assessed with positive market sentiment and an importance score of 9 out of 10. Source: GlobeNewswire.