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Ascendis approval still likely despite PDUFA push out, says BofA

After Ascendis Pharma announced the FDA has extended the TransCon PTH review period by three months and pushed out the prescription drug user fee act ,or PDUFA, action date to August 14, BofA caught up with management, who said that the FDA has not made any additional requests from the company at this time. The firm, which notes that PDUFA extensions are not uncommon with the FDA, continues to believe that a U.S. approval is likely and maintains a Buy rating and $165 price target on Ascendis shares.

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