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FLXN

Flexion

$27.12

0.97 (3.71%)

15:01
10/06/17
10/06
15:01
10/06/17
15:01

Flexion's Zilretta receives FDA approval

Flexion Therapeutics announced that the U.S. Food and Drug Administration approved Zilretta, the first and only extended-release, intra-articular injection for osteoarthritis knee pain. Zilretta is a non-opioid medicine that employs Flexion's proprietary microsphere technology to provide proven pain relief over 12 weeks. "The approval of Zilretta marks a major advancement in the treatment landscape for managing OA knee pain," said Michael Clayman, M.D., President and Chief Executive Officer of Flexion. "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." The FDA approval of Zilretta is based upon data from Flexion's pivotal Phase 3 clinical trial. The randomized, double-blind study enrolled 484 patients at 37 centers worldwide.

  • 06

    Oct

FLXN Flexion
$27.12

0.97 (3.71%)

04/07/17
RAJA
04/07/17
NO CHANGE
RAJA
Strong Buy
Flexion CMO hiring adds to Raymond James' skepticism of takeover speculation
Raymond James analyst Elliot Wilbur previously said he was skeptical of media-driven speculation that Sanofi (SNY) was preparing to bid for Flexion (FLXN), but he views the appointment of Yamo Deniz, another former Sanofi executive, as Flexion's chief medical officer as one more reason to doubt the rumor. Deniz "joins a growing roster of hires" from Sanofi and Wilbur does not believe these individuals, who "would have the best firsthand knowledge of exactly what the buzz is on Zilretta from the Sanofi perspective," would join Flexion simply to rejoin Sanofi again. While he thinks "some deflation" of the takeout premium in the stock could follow this hiring, Wilbur keeps a Strong Buy rating on Flexion shares.
08/24/17
NORL
08/24/17
INITIATION
Target $40
NORL
Outperform
Flexion initiated with an Outperform at Northland
Northland initiated Flexion with an Outperform and a $40 price target saying lead candidate, Zilretta, is positioned to emerge as the first sustained release, non-opioid, intra-articular injectablefor treating osteoarthritis knee (pain. Zilretta has major advantages to existing intra-articular corticosteroids injections as it has a rapid onset of action, provides durable pain relief for at least 3 months, and avoids elevating bloodglucose levels, the firm's analyst wrote in a note to investors.
08/24/17
08/24/17
INITIATION

On The Fly: Top five analyst initiations
Catch up on today's top five analyst initiations with this list compiled by The Fly: 1. Zimmer Biomet (ZBH) initiated with a Buy at Gabelli. 2. Foamix (FOMX) initiated with a Buy at H.C. Wainwright. 3. Netlist (NLST) initiated with a Buy at Roth Capital. 4. Flexion (FLXN) initiated with an Outperform at Northland. 5. USA Technologies (USAT) initiated with an Outperform at William Blair. This list is just a portion of The Fly's full analyst coverage. To see The Fly's full Street Research coverage, click here.
09/29/17
WELS
09/29/17
NO CHANGE
WELS
Flexion's Zilretta likely to be approved by FDA, says Wells Fargo
Wells Fargo analyst David Maris talked to Flexion's management ahead of the October 6 PDUFA for Zilretta, and Maris continues to believe the FDA will approve the drug, which has "the potential to be a game changer in osteoarthritis knee pain treatment." Maris maintained an Outperform rating and $32 price target on Flexion shares.

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PM

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