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FLXN

Flexion

$19.12

-0.685 (-3.46%)

07:39
12/17/19
12/17
07:39
12/17/19
07:39

Flexion enrolls first patients in Phase 2 trial of ZILRETTA

Flexion Therapeutics announced that the first three patients were enrolled in a clinical trial to evaluate the efficacy of ZILRETTA in patients with either shoulder osteoarthritis or adhesive capsulitis, also known as frozen shoulder. The Phase 2 double-blind, placebo-controlled, study is expected to enroll up to 250 patients - approximately 135 with shoulder OA and 115 with shoulder AC. The Phase 2 trial, known as the RANGE study, will separate cohorts of patients by their diagnosis of shoulder OA or AC into two parallel groups. Patients in each cohort will be randomized to either a single intra-articular injection of ZILRETTA or normal saline. The primary endpoint for both cohorts of the trial is the magnitude of pain relief versus placebo as measured by the overall change in daily shoulder pain with movement score from baseline to 8 weeks post injection. Patients in each cohort will be stratified by baseline pain scores. Shoulder AC patients will be further stratified by pain duration since onset and will also utilize a home exercise program during the study. Each participant will be evaluated for 24 weeks following injection. The trial is expected to complete in the first half of 2021.

  • 22

    Jan

FLXN Flexion
$19.12

-0.685 (-3.46%)

05/09/19
BNCH
05/09/19
UPGRADE
Target $19
BNCH
Buy
Flexion upgraded to Buy from Hold at Benchmark
Benchmark analyst Bruce Jackson upgraded Flexion Therapeutics to Buy from Hold with a $19 price target.
10/14/19
BNCH
10/14/19
NO CHANGE
BNCH
Buy
Benchmark still sees Flexion getting expanded label, but not as soon as expected
After Flexion Therapeutics announced that the FDA has extended its review of the Supplemental New Drug Application to update Zilretta's label for repeat administration, Benchmark analyst Bruce Jackson said he continues to believe the company will get expanded labeling, "just not as rapidly as anticipated." Noting that the FDA has not asked for any additional clinical data and informed the company that it expects to complete the review in "the coming weeks," Jackson reiterated his Buy rating on Flexion shares, which are down about 5% in pre-market trading.
11/25/19
BTIG
11/25/19
INITIATION
Target $27
BTIG
Buy
Flexion initiated with a Buy at BTIG
BTIG analyst Tim Chiang initiated coverage of Flexion with a Buy rating and $27 price target. The analyst says that based on his assessment of the osteoarthritis knee pain market, the sales growth of its Zilretta could continue to accelerate into 2020 with up to $500M in sales seen by 2025. Chiang adds that Zilretta is "just scratching the surface" in that some 30M Americans are expected to suffer from knee pain, and sales have accelerated since Flexion received Medicare reimbursement for the treatment.
12/05/19
CHLM
12/05/19
INITIATION
Target $24
CHLM
Buy
Flexion initiated with a Buy at Craig-Hallum
Craig-Hallum analyst Francois Brisebois initiated coverage of Flexion with a Buy rating and $24 price target. In a research note to investors, Brisebois says that while many launches struggle with obstacles such as reimbursement and adoption, he believes Flexion's continued execution is starting to bear fruit as depicted by encouraging launch metrics and sales growth for Zilretta injection for osteoarthritis of the knee. He adds as 1% market penetration represents ~$40M in sales, he believes that even with his conservative 2024 peak sales of ~$539M, Flexion remains undervalued at these levels.

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IMVT

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TBLT

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MYO

Myomo

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  • 21

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SRRA

Sierra Oncology

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SRNE

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AKER

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ECA

Encana

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  • 29

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MBRX

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VOD

Vodafone

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NSCO

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APLS

Apellis

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$NSD

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LGC

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GNUS

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BBY

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