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FLXN

Flexion

$25.18

0.24 (0.96%)

16:36
12/07/17
12/07
16:36
12/07/17
16:36

Flexion enrolls first patient in Phase 2 ZILRETTA study

Flexion Therapeutics announced the enrollment of the first patient in a clinical trial to evaluate the pharmacokinetics and safety of concurrent injections of ZILRETTA in patients with bilateral osteoarthritis of the knee. The randomized, open-label, Phase 2 study is expected to enroll approximately 24 patients. The safety and tolerability of a single injection of ZILRETTA has been established through multiple Phase 2 and Phase 3 clinical trials focused on administration in one knee. ZILRETTA received approval from the U.S. Food and Drug Administration on October 6, 2017 for the management of OA knee pain and the company initiated the full commercial launch on November 20, 2017. The study will compare plasma PK profiles after concurrent injections of ZILRETTA versus immediate-release triamcinolone acetonide in crystalline suspension. Patients will be randomized and treated with bilateral injections of either ZILRETTA or TAcs. Each patient will be evaluated for six weeks following injection. Flexion expects to report top-line results of the study in the first half of 2018.

  • 14

    Dec

FLXN Flexion
$25.18

0.24 (0.96%)

10/10/17
JANY
10/10/17
NO CHANGE
Target $38
JANY
Buy
Flexion price target raised to $38 from $35 at Janney Capital
Janney Capital analyst Ken Trbovich said nothing in the label for Zilretta has changed his view about its long-term potential, noting that he sees the drug as a major advance in the treatment of osteoarthritis knee pain. Trbovich said Flexion management confirmed that its $570 wholesale acquisition cost is expected to translate to net revenue of about $500/ injection, consistent with his expectations. He raised his fair value estimate for Flexion shares to $38 from $35 and keeps a Buy rating on the stock.
10/24/17
BMOC
10/24/17
NO CHANGE
BMOC
Outperform
Flexion well prepared ahead of Zilretta launch, says BMO Capital
BMO Capital analyst Gary Nachman said in a note to investors last night that after meeting with Flexion management he came away impressed with their level of preparedness for the commercial launch of Zilretta. He attributes the stock weakness since the drug's approval to shorter-term trading dynamics until management can demonstrate execution, but he thinks expectations have been lowered and are becoming much more achievable. Nachman keeps an Outperform rating on Flexion shares.
10/27/17
RBCM
10/27/17
NO CHANGE
RBCM
Flexion shares at compelling entry point after 34% pullback, says RBC Capital
RBC Capital analyst Randall Stanicky reiterated an Outperform rating and $44 price target on Flexion, saying he sees the 34% pullback in Flexion shares this month ahead of the Zilretta launch as short term, given the company's solid funding of about $12 cash per share, its thematic positioning as an opioid alternative, and its inherent strategic value.
10/30/17
WELS
10/30/17
NO CHANGE
Target $39
WELS
Outperform
Survey suggests Flexion Zilretta will be 'a hit,' says Wells Fargo
Wells Fargo analyst David Maris notes that while Flexion shares have declined in recent weeks following the approval of Zilretta and its subsequent equity offering, he believes this decline is mainly due to lack of near-term news flow, not a change in fundamentals. Citing a survey of 25 orthopedic surgeons, the analyst says results are very consistent with previous physician surveys and doctor interviews, indicating "significant potential" for Zilretta. If Zilretta reaches 37% penetration in OA knee, as the survey results suggest, it would generate more than $1B in revenue, he contends. Maris reiterates an Outperform rating and $39 price target on the shares.

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