Flexion Therapeutics, Inc. FLXN were up 9.2% following FDA approval to the supplemental New Drug Application (sNDA) to update its osteoarthritis (“OA”) knee pain drug, Zilretta’s label. The approval to the sNDA, which sought removal of confusing limitation of use label, comes two months after the scheduled date. The FDA had informed the company in October that more time is required for the completion of the sNDA review.
Zilretta was approved in 2017 as the first and the only extended-release intra-articular therapy providing relief to OA patients with knee pain for over a period of 12 weeks.
Following the FDA approval, “not intended for repeat administration” will be removed from the drug’s label and replaced with “efficacy and safety of repeat administration of ZILRETTA have not been demonstrated.” The label update will also remove a misleading statement related to a single secondary exploratory endpoint in the original pivotal phase III study. The study compared Zilretta to immediate release triamcinolone acetonide crystalline suspension.
Moreover, it will also include safety data from a phase III study evaluating repeat administration of Zilretta and previously submitted non-clinical toxicology data from single and repeat administration studies in non-diseased animals.
The company believes that the updated label for Zilretta will remove confusion among patients, doctors and payers related to the use of the drug. The clarity following the update is likely to help patients get reimbursement from insurers on its repeat use and boost sales. With this label expansion, the company expects Zilretta to become the leader in intra-articular therapy for managing OA knee pain.
We note that sales of Zilretta have grown significantly sequentially in the past three quarters. Total sales of the drug in the first nine months of 2019 were $49.3 million compared with $13 million in the year-ago period.
Shares of Flexion have surged 85% in the past year, significantly outperforming the
industry’s increase of 12.9%.
Apart from OA knee pain, the company is also evaluating Zilretta as a treatment for patients with hip OA in a phase III study. It is also conducting phase II studies on Zilretta for treating shoulder OA and shoulder adhesive capsulitis (frozen shoulder). The company is also developing a gene therapy, FX201, for the treatment of OA in an early-stage study.
Zacks Rank & Stocks to Consider
Flexion currently carries a Zacks Rank #4 (Sell).
Some better-ranked pharma stocks to consider include Alkermes plc
ALKS, Coherus BioSciences, Inc. ( CHRS Quick Quote CHRS - Free Report) and BioDelivery Sciences International, Inc. BDSI. While Alkermes and Anika sport a Zacks Rank #1 (Strong Buy), BioDelivery carries a Zacks Rank #2 (Buy). You can see . the complete list of today’s Zacks #1 Rank stocks here
Alkermes’ earnings estimates increased from 50 cents to 59 cents for 2020 over the past 60 days. The company delivered a positive earnings surprise in the trailing four quarters, the average beat being 236.8%.
BioDelivery’s earnings estimates increased from 22 cents to 31 cents for 2020 over the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters, the average beat being 159.38%. Share price of the company has increased 78.4% so far this year.
Coherus’ earnings estimates increased from $1.25 to $1.67 for 2020 over the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters, the average beat being 149.94%. Share price of the company has increased 101.1% so far this year.
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