Ascendis Pharma's (ASND) PDUFA Disclosure Removes Near-Term Stock Upside - Stifel

Stifel analyst Alex Thompson reiterated a Buy rating and $254.00 price target on Ascendis Pharma (NASDAQ: ASND).

The analyst commented, "We remain Buy Rated on ASND following the disclosure of a PDUFA extension (+3Mo) for the review of TransCon CNP following a major amendment related to submission of a new post-marketing study protocol--new PDUFA 2/28/26. We caught up with management who emphasized that only the PMR is under discussion--nothing related to the filing, with labeling, artwork, and packaging all finalized. It's possible that approval could come prior to the new PDUFA with management expecting to engage with FDA as quickly as possible. This comes in the wake of other recent extensions (DNLI/RYTM) over seemingly small asks, and it's unclear whether the agency is leveraging major amendments as a way to alleviate internal staffing constraints. For the stock, this removes some potential nearterm upside via a new commercial launch (albeit with the remaining IP litigation overhang), though the core of our thesis remains focused on Yorvipath growth in Hypoparathyroidism."

For an analyst ratings summary and ratings history on Ascendis Pharma click here. For more ratings news on Ascendis Pharma click here.

Shares of Ascendis Pharma closed at $206.65 yesterday.

You May Also Be Interested In

• Piper Sandler: PFA survey is most positive for Medtronic, Inc. (MDT)
• Citi says positioning risk is shifting from short squeezes to profit-taking
• Bernstein SocGen Group Reiterates Outperform Rating on Centene (CNC), discusses CFO change