AMAG Pharmaceuticals downgraded to neutral from buy at Janney

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Palatin shares surge 9% premarket after FDA accepts for review treatment for HSDD

Palatin Technologies Inc. shares surged 9% in premarket trade Monday, after the company said the U.S. Food and Drug Administration has accepted the new drug application for bremelanotide, a treatment for female sexual desire disorder. The NDA was filed by Amag Pharmaceuticals Inc. , Palatin’s exclusive North America licensee, in March. The goal date for completion of the review is March 23, 2019. If approved, bremelanotide would be the first and only treatment for hypoactive sexual desire disorder (HSDD) in pre-menopausal women, that can be taken as desired. The FDA’s acceptance has triggered a $20 million milestone payment to Palatin under its agreement with Amag Pharma. Palatin can receive up to $80 million in milestone payments, and is also entitled to received tiered royalties on sales ranging from high single-digit to low double-digit percentages and up to $300 million contingent upon meeting certain sales milestones. HSDD affects about 12 million women in the U.S. Palatin shares have gained 38.6% in 2018 so far, while the S&P 500 has gained 2.3%.

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