|Revance CEO Dan Browne|
Revance Therapeutics' ($RVNC) top prospect, a topical successor to Botox, has fallen off schedule, putting off the company's Phase III plans until next year and sending its shares southward.
In its quarterly earnings statement, Revance disclosed that RT001 isn't yet ready to enter late-stage development as a treatment for crow's feet, yet another delay for a drug once expected to wrap up Phase III this year. RT001 is currently in an open-label study, and, looking at preliminary results, Revance has concluded that "we still have some work to do to optimize the transfer of manufacturing to our commercial facility and increase the probability of success for our upcoming Phase III pivotal program," CEO Dan Browne said in a statement.
"We are encouraged by the valuable and promising efficacy data observed among the patient and physician measurements, but the preliminary composite results were not adequate to move forward with our Phase III pivotal study at this time," Browne said. "As a next step, we plan to complete the ongoing open-label study, fully analyze the data and manufacture additional RT001 drug product in our commercial facility to support a subsequent study expected to commence in early 2015."
The setback sent Revance's shares down more than 30% on Thursday morning, as investors are growing all the more skeptical of the company's plans to unseat injectable treatments like Botox with a topical solution. In its IPO pitch last year, Revance touted RT001 as poised to disrupt the $1.4 billion aesthetic dermatology market for such drugs, planning to launch it with a small sales force.
Those ambitions are now on hold, but Revance is staying optimistic about its pipeline potential. Beyond the crow's feet indication, RT001 is slated to enter a Phase II trial in excessive sweating next year, the company said, and the injectable RT002 is on course to begin mid-stage study in frown lines by year's end.
The promise of that pipeline helped Revance pull off a $96 million IPO in the first quarter, part of a record-setting deluge of biotech debuts that saw nearly 30 companies bring in more than $2 billion.
- read the statement