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FLXN

Flexion

$25.25

-0.29 (-1.14%)

07:40
01/08/18
01/08
07:40
01/08/18
07:40

Flexion announces initial data from trial for repeat administration of Zilretta

Flexion Therapeutics announced initial findings from its ongoing Phase 3b, open-label study to evaluate the repeat administration of Zilretta in patients with osteoarthritis, or OA, of the knee. The data show that of the 205 evaluable patients enrolled in the study, 95% experienced clinical benefit by Week 12 following the initial injection of Zilretta, as determined by self-assessment and with the agreement of their physician. Furthermore, to date 90% of eligible patients have received a second dose of Zilretta between Weeks 12 and 24, with three patients still pending repeat administration. "These data are very encouraging and provide us with the first glimpse of how Zilretta can perform in a real-world setting," said Michael Clayman, M.D., President and CEO of Flexion. "In particular, we are pleased with the observation that the vast majority of patients have experienced clinical benefit and that so many of them elect to have a second injection." The primary endpoint of the trial is overall safety and general tolerability of repeat administration of Zilretta in patients with symptomatic OA of the knee. Participants received an initial intra-articular injection of Zilretta followed by evaluation at Weeks 12, 16, 20 or 24 to determine their eligibility for a second injection. Repeat administration occurred when, in the opinion of the patient and physician, the patient benefited from and tolerated the initial administration without safety concerns and was clinically indicated to receive additional treatment.

FLXN Flexion
$25.25

-0.29 (-1.14%)

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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