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MAA Withdrawn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.
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
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