Dermira Inc. (DERM) investors are nice and dry following its latest regulatory news.
Shares in the Menlo Park, Calif., biotech company rose 95 cents -- or 9.73% -- to $10.88 a share in early trading Friday after the company reported it had received approval from the U.S. Food and Drug Administration for its new cloth designed to treat patients with excessive underarm sweating.
Shares at midday remained up 4% at $9.14 but far below the earlier trading price and a premarket spike of 25%.
Dermira's Qbrexza topical cloth is the first FDA-approved treatment for people with primary axillary hyperhidrosis, a condition that affects an estimated 10 million people in the U.S. Qbrexza is designed to stop sweat production by "inhibiting sweat gland activity" when the cloth is applied to the skin. According to the company, Phase 3 trial results showed Qbrexza reduced the amount of sweat a patient produced by an average of 15 to 20 milligrams more than the comparison vehicle.
"I look forward to Qbrexza's potential to be a meaningful treatment option that will not only reduce a person's sweat but will reduce the overall impact this condition has on their daily life," Dr. Dee Anna Glaser, interim chair of the Department of Dermatology at St. Louis University School of Medicine, said in the statement. Glaser is a hyperhidrosis expert, Dermira said.
Qbrexza is expected to hit the markets by October, the company said.