Kythera Biopharmaceuticals ($KYTH) has encouraged investors with successful results from two late-stage studies of its lead product candidate, ATX-101, an injected therapy for wiping out chin fat.
Shares of the Calabasas, CA-based biotech outfit shot up more than 25% to $42 midmorning on Tuesday after its Monday release on the results. The promise of ATX-101 could make Kythera a buyout target, an analyst from Cowen & Co. noted, and recommended buying the company's shares.
Kythera succeeded in both the primary and secondary endpoints of two pivotal Phase III trials in the U.S. and Canada for ATX-101 for shrinking submental (chin) fat. The company's experimental therapy, which is a proprietary version of a natural molecule called deoxycholic acid that breaks down dietary fats in humans, beat placebo in both the REFINE-1 and REFINE-2 studies of more than 500 patients each.
Less than 4% of patients dropped out because of adverse events, the company said, noting that the most common side effects were mild to moderate pain, redness, bruising and numbness.
"An undesirable double chin is often undertreated by aesthetic physicians as there is no proven non-surgical option to effectively reduce submental fat," said Dr. Jean Carruthers, an investigator of the REFINE-1 study from the University of British Columbia, in a statement. "ATX-101 could provide a solution that fulfills this unmet need and become an important addition to the overall practice of aesthetics."
Bayer HealthCare controls rights to ATX-101 for markets outside the U.S. and Canada. And Kythera aims to begin talks soon with U.S. and Canadian regulators about submissions for approval.
"With these results, we believe the story will now pivot to the commercial opportunity, which we believe is significant and still underappreciated by the Street ($500MM+ in the U.S. alone)," Cowen analyst Ken Cacciatore wrote in a note to investors."
"Additionally," Cacciatore noted, "given the lack of viable aesthetic products, it would not be surprising if a strategic buyer made the wealth-creating decision to acquire the asset."
- here's the company's release
- and Reuters' article