Sign up today for an exclusive discount along with our 30-day GUARANTEE — Love us or leave, with your money back! Click here to become a part of our growing community and learn how to stop gambling with your investments. We will teach you to BE THE HOUSE — Not the Gambler!

Click here to see some testimonials from our members!

Flexion Analysts Say Long-Delayed Zilretta Label Expansion A Relief For Investors

Courtesy of Benzinga

Flexion Analysts Say Long-Delayed Zilretta Label Expansion A Relief For Investors

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. 

Related Links:

10 Biotech M&A Targets Under The Scanner For 2020

Acasti Delays Data Readout For Drug To Treat Elevated Triglycerides

Latest Ratings for FLXN

Date Firm Action From To
Dec 2019 Maintains Strong Buy
Dec 2019 Initiates Coverage On Buy
Nov 2019 Initiates Coverage On Buy

View More Analyst Ratings for FLXN


View the Latest Analyst Ratings

Posted-In: Analyst Color News Health Care Price Target Reiteration FDA Analyst Ratings General Best of Benzinga


Do you know someone who would benefit from this information? We can send your friend a strictly confidential, one-time email telling them about this information. Your privacy and your friend's privacy is your business... no spam! Click here and tell a friend!





You must be logged in to make a comment.
You can sign up for a membership or get a FREE Daily News membership or log in

Sign up today for an exclusive discount along with our 30-day GUARANTEE — Love us or leave, with your money back! Click here to become a part of our growing community and learn how to stop gambling with your investments. We will teach you to BE THE HOUSE — Not the Gambler!

Click here to see some testimonials from our members!