Palatin Technologies, Inc. (NYSE:PTN) shares gained ground after the FDA approved NDA for Vyleesi for the treatment of pre-menopausal women with acquired HSDD.
Vyleesi™ (bremelanotide injection) is a melanocortin receptor agonist developed by Palatin indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD). The FDA's approval of the NDA triggers a $60 million milestone payment to Palatin under its North American license agreement with AMAG.
According to CEO Carl Spana, "We are incredibly excited with the FDA's decision to approve the NDA for Vyleesi as a treatment for premenopausal women with HSDD.
"This FDA approval means that pre-menopausal women with HSDD now have a safe and effective, as-needed treatment option available to them.
"The Vyleesi approval is an important milestone for Palatin's employees and shareholders. It reflects our commitment, ability, and dedication to the discovery, development and regulatory approval of novel products with significant unmet medical need and commercial potential.
Vyleesi is the first FDA-approved product for the as needed treatment of premenopausal women who experience distress or interpersonal difficulty due to low sexual desire. While the exact mechanism of action is unknown, Vyleesi is believed to bind to melanocortin receptors in the central nervous system that are thought to be associated with sexual function.
Under the terms of the agreement with AMAG, signed in January 2017, Palatin is entitled to receive $60 million upon regulatory approval by the FDA. This payment is expected to be received in July.
Shares acquired 17 cents, or 12.5%, to $1.51
