Citi opens ‘upside Catalyst Watch’ on Ascendis into FDA feedback

Citi analyst David Lebowitz opened a “30-day upside Catalyst Watch” on shares of Ascendis Pharma for the FDA’s upcoming feedback on TransCon PTH’s new drug application for the treatment of hypoparathyroidism. Within 30 days, the FDA will indicate if the application is a Class 1, or two-month review, or Class 2 resubmission, or six-month review, or less likely, if the agency does not believe the application completely addresses deficiencies outlined in the complete response letter, the analyst tells investors in a research note. Citi is a buyer of the stock ahead of the agency’s feedback, as it views the most likely scenario to be a Class 2 resubmission, which it estimates could provide 5%-20% upside from current share levels. The firm has a Buy rating on Ascendis with a $146 price target.