Risk Confirmed: Ultragenyx Shares Downgraded To Sell By Citi

Citi’s Yigal Nochomovitz believes the “opportunity set” for Ultragenyx Pharmaceutical Inc RARE's pipeline is fully valued in the mid-$60s.

Nochomovitz downgraded the rating on the company from Neutral to Sell, while lowering the price target from $66 to $64.

MAA Withdrawn

“We had always viewed the EU conditional filing for Ace-ER as risky given the small and exploratory Ph2 lacking a primary endpoint. The withdrawal of the MAA following a CHMP hearing earlier this week confirms this risk,” the analyst mentioned.

Ultragenynx Pharma had announced the withdrawal of the Marketing Authorization Application (MAA) for Ace-ER in the EU on November 11.

Nochomovitz now awaits the Phase 3 data, which is expected in H2:17, to re-evaluate the Ace-ER opportunity.

However, the stock appreciated 4.24 percent on November 11, following the company reporting the withdrawal of the MAA.

BLA Filing

On the other hand, management recently completed a meeting with the FDA regarding KRN23, where the FDA indicated that Ultragenyx Pharma did not need to complete the ongoing Phase 3 pediatric trial in order to file the BLA.

However, it is still unclear whether the company would need to complete the Phase 3 trial for filing, due to which Ultragenyx Pharma now intends to file the BLA for KRN23 in H2:17.

At last check, Ultragenyx was down 3.66 percent at $79.06.