Flexion Therapeutics Inc (NASDAQ:FLXN) investors have a smile on their faces Friday evening, after the drug maker announced that the FDA approved its osteoarthritis knee pain treatement Zilretta. Zilretta is a non-opioid medicine that employs Flexion’s proprietary microsphere technology to provide proven pain relief over 12 weeks.
In reaction to the approval, FLXN shares rose just over 10% to close at $29.93.
RBC Capital analyst Randall Stanicky noted, “We have modeled $1.05 billion in peak sales. Pricing of ~$500/ dose is seemingly the right pricing model which would still put Zilretta at a discount to branded opioids (over 3-month dosing regimen), and we think the product’s appreciation as an opioid alternative will increase post approval. We also see diabetes patients at >20% of OA treated with IA injections as a core part of the market where Zilretta should see first line use supported by our prior survey work.”
Stanicky rates FLXN shares an Outperform with a 12-month price target of $44.00, which implies a 40% upside potential from current levels. (To watch Stanicky’s track record, click here)
Flexion CEO Michael Clayman commented, “The approval of Zilretta marks a major advancement in the treatment landscape for managing OA knee pain […] It comes at a time when our society is in urgent need of non-addictive therapies to help the millions of Americans who suffer from this condition.” Dr. Clayman added, “We believe that Zilretta has the potential to be a transformative medicine for the more than five million patients who receive an intra-articular injection for OA knee pain each year.”
Steven Russell, M.D., Ph.D., Assistant Professor of Medicine, Massachusetts General Hospital Diabetes Research Center, commented, “Our trial demonstrated that Zilretta may avoid the disruptive blood glucose spikes that can be seen with corticosteroid use in patients coping with both knee OA and type 2 diabetes. As a practicing diabetologist, I believe the availability of Zilretta will make intra-articular injection of glucocorticoid an attractive option for these patients.”
TipRanks reveals that FLXN has a Strong Buy analyst consensus rating with 5 back-to-back buy ratings in the last three months. Meanwhile the average analyst price target of $38.80 suggests the stock still has upside potential of just over 30% from the current share price for the next 12 months.
Flexion Therapeutics, Inc. is a pharmaceutical company, which focuses on the development and commercialization of novel, local therapies. The firm specializes in treatment of patients with musculoskeletal conditions including osteoarthritis. It offers products under the Zilretta brand.