$EDAP.. price target lowered to $4.50 from $6 at H.C. Wainwright
H.C. Wainwright lowered its price target for EDAP TMS shares to $4.50 saying a positive FDA decision is unlikely after an FDA panel was "unanimously negative" on the company's treatment of low-risk, localized prostate cancer. The firm still believes Ablatherm will continue to grow its market share in Europe and keeps a Buy rating on the stock.
07:10 EDT..EDAP..says FDA panel votes against Ablatherm-HIFU device
EDAP TMS announced last night that the FDA's Gastroenterology and Urology Devices Panel voted 3 yes, 5 no with 1 abstention on the question of safety, 9 no on the question of efficacy, and 8 no with 1 abstention for the risk/benefit ratio for the use of its Ablatherm-HIFU device for the treatment of low-risk, localized prostate cancer. Marc Oczachowski, EDAP's CEO, commented, "We are disappointed by the Committee's recommendation regarding Ablatherm-HIFU for the treatment of low-risk, localized prostate cancer and we appreciate the dialogue during today's meeting. We look forward to subsequent discussion with the FDA. We will continue to work diligently with the FDA as it carefully completes its final review for Ablatherm-HIFU's PMA."
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