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NVCN

Neovasc

$0.51

-0.0089 (-1.71%)

07:01
11/28/16
11/28
07:01
11/28/16
07:01

Neovasc receives regulatory approval to initiate TIARA II CE Mark study

Neovasc announced it has received both regulatory and ethics committee approval to initiate the Tiara Transcatheter Mitral Valve Replacement Study in Italy. TIARA II is a 115 patient, non-randomized, prospective clinical study evaluating the safety and performance of the Tiara Transcatheter Mitral Valve with the Tiara Transapical Delivery System. With these critical approvals now in place, it is expected that the first Italian TIARA II clinical study site will be initiated before year end, with first enrollment anticipated early in the new year. Approvals in additional geographies are expected in the first quarter of 2017. It is expected that data from this study will be used to file for CE Mark approval for Tiara. CE Mark is the European Union regulatory approval to commercialize a medical device. Receiving the CE Mark demonstrates that a product has been assessed by the EU authorities and conforms to the European essential requirements for safety and performance.

NVCN Neovasc
$0.51

-0.0089 (-1.71%)

12/10/15
12/10/15
INITIATION

On The Fly: Analyst Initiation Summary
Today's noteworthy initiations include: Allied World (AWH) initiated with an Overweight at Piper Jaffray... Apollo Global (APO) initiated with a Buy at Jefferies... Argo Group (AGII) initiated with an Overweight at Piper Jaffray... Aspen Insurance (AHL) initiated with a Neutral at Piper Jaffray... Avago (AVGO) initiated with an Outperform at FBR Capital... Blackbaud (BLKB) initiated with an Outperform at Baird... Bravo Brio Restaurant (BBRG) initiated with a Neutral at Sidoti... Cabot (CBT) initiated with a Buy at BB&T... Carlyle Group (CG) initiated with a Hold at Jefferies... Cavium (CAVM) initiated with a Neutral at BofA/Merrill... First Data (FDC) initiated with a Market Perform at Bernstein... Heron Therapeutics (HRTX) initiated with a Buy at Lake Street... Hexcel (HXL) initiated with a Buy at BB&T... IPG Photonics (IPGP) initiated with a Perform at Oppenheimer... Just Energy (JE) initiated with a Buy at Rodman & Renshaw... KKR (KKR) initiated with a Buy at Jefferies... Match Group (MTCH) initiated with a Buy at UBS... Mobileye (MBLY) initiated with a Market Perform at FBR Capital... Neovasc (NVCN) initiated with a Buy at Ladenburg... Newtek Business Services (NEWT) initiated with an Outperform at Keefe Bruyette... Parsley Energy (PE) initiated with a Buy at Stifel... PennyMac Financial (PFSI) initiated with an Overweight at Barclays... PennyMac Mortgage (PMT) initiated with an Overweight at Barclays... Rice Energy (RICE) initiated with a Buy at Stifel... SAIC (SAIC) initiated with a Buy at SunTrust... Trimble (TRMB) initiated with an Outperform at Oppenheimer... Vuzix (VUZI) initiated with a Buy at Rodman & Renshaw... W.R. Grace (GRA) initiated with a Hold at BB&T.
03/30/16
ADAM
03/30/16
NO CHANGE
Target $10
ADAM
Buy
Neovasc price target lowered to $9.50 from $15 at Canaccord
Canaccord lowered its price target on Neovasc to $9.50 from $15 despite viewing the company as an attractive long-term asset in the transcatheter mitral valve replacement space. The firm continues to believe the company could be an acquisition target and sees a near-term catalyst with the company's plans to initiate their European CE Mark study in the second half of the year. Canaccord maintained its Buy rating on Neovasc shares.
05/20/16
LTCO
05/20/16
DOWNGRADE
LTCO
Neutral
Neovasc downgraded to Neutral from Buy at Ladenburg
Ladenburg Thalmann analyst Jeffrey Cohen downgraded Neovasc to Neutral after a jury found in favor of CardiAQ and awarded the company $70M.
05/20/16
JMPS
05/20/16
NO CHANGE
JMPS
Neovasc price target lowered to $5 from $10 at JMP Securities
JMP Securities lowered its price target on Neovasc (NVCN) after the company lost a trial to Edwards' (EW) CardiAQ. The firm says that Neovasc may be able to preserve its Tiara valve, but it thinks there is "significant uncertainty" about the product in the wake of the verdict. It reiterates an Outperform rating on the shares.

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IRDM

Iridium

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TKTDY

Takata

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1.2199 (63.21%)

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SEAS

SeaWorld

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FRO

Frontline

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GOOG

Alphabet

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BHVN

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