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VIVE

Viveve

$2.34

-0.24 (-9.30%)

08:29
08/07/18
08/07
08:29
08/07/18
08:29

Viveve announces FDA approval to continue VIVEVE II clinical study

Viveve Medical announced that it has received clearance from the U.S. Food and Drug Administration to continue enrollment in the company's multicenter randomized Viveve Treatment of the Vaginal Introitus to EValuate Safety and Efficacy clinical trial to assess the safety and effectiveness of the Viveve System for the improvement of sexual function in women following vaginal childbirth. The Agency's approval was based on a determination that the company provided sufficient data to support continued subject enrollment in the trial and that there are no subject protection concerns that preclude continuation of the study. "This clearance to continue enrollment represents a major step forward in the progression of the VIVEVE II trial and for women seeking an improvement in sexual function following child birth. Following FDA review of the second stage of safety data, and approval of an IDE supplement to expand the study, Viveve plans to continue enrollment up to 250 patients," stated CEO Scott Durbin.

  • 09

    Aug

VIVE Viveve
$2.34

-0.24 (-9.30%)

06/19/18
MAXM
06/19/18
NO CHANGE
Target $9
MAXM
Buy
Maxim remains a buyer of Viveve shares after data report
Maxim analyst Anthony Vendetti would continue to be a buyer of Viveve shares after the company's report of positive interim 6-month data from its ongoing 12-month SUI feasibility study. He views SUI as another large market for the company and believes the company's multi-pronged approach of pursuing SUI and female sexual function indications can provide a significant competitive edge for the Viveve System. He maintains a Buy rating and $9 price target on Viveve shares.
07/11/18
MZHO
07/11/18
NO CHANGE
Target $4
MZHO
Buy
Viveve Q2 results 'step in the right direction,' says Mizuho
Mizuho analyst Difei Yang views Viveve Medical's preliminary Q2 results as a "step in the right direction" as revenue topped expectations and 2018 guidance was reaffirmed. However, it is "premature to declare victory," as the growth trend of treatment tips needs to be further understood, Yang tells investors in a research note. She keeps a Buy rating on Viveve with a $4 price target.
07/30/18
CHLM
07/30/18
NO CHANGE
CHLM
Hold
FDA warning to off-label competitors positive for Viveve, says Craig-Hallum
Craig-Hallum analyst Matt Hewitt noted that the FDA published seven "Letters to Industry" that were sent to companies that may be violating the law for inappropriately marketing their energy-based devices for vaginal "rejuvenation," but noted that Viveve (VIVE) was not amongst them. He views this as a positive for Viveve, as it signals that the FDA is cracking down on the off-label promotion that he thinks has been a key commercial challenge for the company. Viveve is the only one in the space currently performing a trial for sexual function, placing it "miles ahead of the competition" in terms of obtaining an actual label, added Hewitt, who keeps a Hold rating on the stock due to concerns over the company's operating cash flow burn and uncertainty about financials. The Fly notes that Cynosure, a unit of Hologic (HOLX), was among the companies to receive an FDA warning.
07/31/18
MZHO
07/31/18
NO CHANGE
Target $4
MZHO
Buy
Seven Viveve competitors get FDA warning letters, says Mizuho
The FDA issued a warning letter to seven competitors of Viveve Medical related to the inappropriate marketing of energy-based devices for the treatment of vaginal rejuvenation, Mizuho analyst Difei Yang tells investors in a research note. The analyst anticipates the competitors will likely stop marketing their devices "off label" in the near term. Since Viveve has not received a letter, Yang sees the development as a positive for the company. The letters to competitors will likely provide an opportunity to compete on equal footing with more established players, especially considering Viveve has received two investigational device exemptions from the FDA to conduct clinical trials in both sexual function and stress urinary incontinence, Yang tells investors in a research note. She reiterates a Buy rating on Viveve shares with a $4 price target.

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Sea Limited

$12.18

-0.52 (-4.09%)

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BILI

Bilibili

$13.61

0.575 (4.41%)

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LTM

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$9.24

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SPY

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FL

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FE

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FIZZ

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OSK

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MDU

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MDU

MDU Resources

$26.10

-0.49 (-1.84%)

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FL

Foot Locker

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