Flexion Therapeutics Inc (NASDAQ: FLXN) shares are on a tear after the FDA approved an update this week of the product label for its osteoarthritis pain drug Zilretta, which was originally approved in October 2017.
The Flexion Analysts
Needham analyst Serge Belanger maintained a Buy rating on Flexion with a $36 price target.
Raymond James analyst Elliot Wilbur maintained a Strong Buy rating and hiked the price target from $25 to $28.
Needham Says Flexion Investors Should Be Relieved
The approval of the sNDA, which sought expansion of the product label for repeat-dose administration, was overdue by two months, Needham analyst Belanger said in a note.
The approval essentially updates the label by removing a limitation of use, or LOU, for repeat-dosing administration and by including additional safety data from the Phase 3 repeat-dose trial, the analyst said.
The update will also leave out confusing language regarding the comparison of Zilretta to IR triamcinolone, he said.
"Overall, we believe FLXN achieved its key goal of removing the LOU, which was a source of confusion for many physicians, and is now in a position to better promote Zilretta usage."
The approval will relieve investor concerns related to the long-delayed PDUFA decision, Belanger said.
The next key catalyst for Flexion is the issuing of 2020 Zilretta sales guidance in early January, according to Needham.
Raymond James Says A Potential Hindrance Is Gone
The sNDA approval cleared another potential hindrance for further Zilretta launch ascension, Wilbur said in a Friday note.
"The decision comes some two months after the original PDUFA date as FDA had indicated more time was required to complete the review of the sNDA filing in mid-October," the analyst said.
The label expansion was aimed at indicating that repeat administration of Zilretta was safe and well-tolerated, according to Raymond James.
Flexion Price Action
The stock was trading 13.8% higher at $21.82 at the time of publication.