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MDXG

MiMedx

$13.51

0.31 (2.35%)

07:32
10/17/17
10/17
07:32
10/17/17
07:32

MiMedx notified by FDA to proceed with Phase 2B IND trial for osteoarthritis

MiMedx has been notified by the FDA that its Investigational New Drug Phase 2B clinical study for osteoarthritis of the knee may proceed. The clinical study consists of a Phase 2B, prospective, double-blinded, randomized controlled trial of MiMedx's AmnioFix Injectable, compared to saline placebo in the treatment of knee osteoarthritis. The trial will enroll approximately 318 patients and the company expects patient enrollment to commence in the next quarter. The company indicated the IND Phase 2 clinical study objective is to determine the safety and effectiveness of AmnioFix Injectable as compared to the 0.9% Sodium Chloride USP placebo injection control for the treatment of osteoarthritis of the knee. The primary efficacy endpoints of this study will be the change in Visual Analog Scale score and the change in Western Ontario and McMaster Universities osteoarthritis index for patients between baseline and Day 90 between the AmnioFix Injectable group versus the placebo-control group.

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MDXG MiMedx
$13.51

0.31 (2.35%)

09/22/17
PIPR
09/22/17
NO CHANGE
Target $18
PIPR
Overweight
MiMedx shares offer 'highly attractive entry point,' says Piper Jaffray
Piper Jaffray analyst Matt O'Brien believes the recent pullback in shares in MiMedx Group brings a "highly attractive entry point." Short reports can have a dramatic impact in the short term, but generally end up immaterial, O'Brien tells investors in a research note after MiMedx hosted a business update call and addressed the recent reports. He believes the company has multiple catalysts to drive "significant" revenue growth in the coming years and drive the multiple higher as it transitions to a biopharma company. O'Brien has an Overweight rating on MiMedx with an $18 price target.
09/06/17
NEED
09/06/17
NO CHANGE
NEED
MiMedx should get revenue boost from VLU indication, says Needham
After MiMedx announced that its venous leg ulcer, or VLU, randomized controlled trial was accepted for publication in The International Wound Journal, Needham analyst Mike Matson thinks the results are favorable versus a competing treatment, Organogenesis Apligraf. He estimates that coverage of the VLU indication could generate $75M-$150M of incremental revenue for MiMedx in 2018. He raised his price target on the shares to $21 from $20 and keeps a Strong Buy rating on the stock.
09/05/17
PIPR
09/05/17
NO CHANGE
PIPR
Overweight
MiMedx yearly guidance likely to be raised with Q3 release, says Piper Jaffray
Piper Jaffray analyst Matt O'Brien noted the strong momentum MiMedx saw in the first half has continued into Q3. While the company said it sees beating its Q3 revenue guidance but left its full year view unchanged for now, he "fully" expects guidance will be raised with its Q3 report. O'Brien recommends investors become increasingly aggressive on pullbacks in MiMedx and keeps an Overweight rating on the shares.
08/31/17
PIPR
08/31/17
NO CHANGE
PIPR
Overweight
Piper says MiMedx study publication provides 'ammuntion' in insurance fight
Piper Jaffray analyst Matt O'Brien believes MiMedx has one of the best products for treating Venous Leg Ulcers, or VLUs, and he sees the publication of their latest peer-reviewed clinical study as "more ammunition" as the company lobbies insurance providers to pay in these cases. With peer-reviewed data in hand, he sees the company announcing positive coverage decisions in the coming quarters, he tells investors. O'Brien keeps an Overweight rating on MiMedx and recommends investors get "increasingly aggressive" on any pullbacks.

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