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TRIB

Trinity Biotech

$12.99

-0.23 (-1.74%)

08:41
10/04/16
10/04
08:41
10/04/16
08:41

Trinity Biotech announces withdrawal of Troponin FDA 510(k) Submission

Trinity Biotech announced that it is withdrawing its 510(k) premarket notification submission for the Meritas Troponin-I Test and Meritas Point-of-Care Analyzer. The company held a meeting with the FDA on Thursday September 29, in order to obtain an update on the company's Meritas Troponin submission. At this meeting the FDA asked Trinity to consider withdrawing their submission, due to some concerns they have about the submission. Their primary concerns relate to the device's operating temperature range and that the Troponin-I clinical performance is not consistent with the clinical performance data presented by the most recently cleared laboratory Troponin device. "Whilst we believe that the Meritas product demonstrates excellent performance for a point-of-care product and is superior to all existing point-of-care Troponin products in the market, we decided yesterday to withdraw the submission. Over the coming weeks we will engage with the FDA to gain a better understanding of the nature of their concerns. However, it is our understanding that in order for any new point-of-care Troponin product to obtain clearance, the FDA will require it to demonstrate performance equivalent to the most recently cleared laboratory based device. Our decision to withdraw is based on the fact that, notwithstanding its excellent performance characteristics, we believe that there is no certainty that this level of performance can be achieved by the Meritas product even with the benefit of further development efforts," the company said.

TRIB Trinity Biotech
$12.99

-0.23 (-1.74%)

10/23/15
CHLM
10/23/15
DOWNGRADE
Target $14
CHLM
Hold
Trinity Biotech downgraded to Hold from Buy at Craig-Hallum
Craig-Hallum downgraded Trinity Biotech to Hold to reflect continued slow growth and weak margins in the existing business. The firm lowered its price target on shares to $14 from $24.
10/23/15
10/23/15
DOWNGRADE

On The Fly: Analyst Downgrade Summary
Today's noteworthy downgrades include: A. Schulman (SHLM) downgraded to Accumulate from Buy at Seaport Global... American Electric (AEP) downgraded to Neutral from Outperform at Credit Suisse... Applied Materials (AMAT) downgraded to Neutral from Buy at Citi... ArcelorMittal (MT) downgraded to Neutral from Outperform at Credit Suisse... BE Aerospace (BEAV) downgraded to Sector Perform from Outperform at RBC Capital... Banner Corp. (BANR) downgraded to Market Perform from Outperform at Keefe Bruyette... CEMEX (CX) downgraded to Equal Weight from Overweight at Barclays... Cabela's (CAB) downgraded to Market Perform from Outperform at Barrington... Cameron (CAM) downgraded to Market Perform from Outperform at Raymond James... Community Financial (TCFC) downgraded to Market Perform at Keefe Bruyette... Cypress Semiconductor (CY) downgraded to Buy from Strong Buy at Needham... Diana Shipping (DSX) downgraded to Hold from Buy at Jefferies... Dunkin' Brands (DNKN) downgraded to Neutral from Overweight at Piper Jaffray... Emerge Energy (EMES) downgraded to Neutral from Buy at Seaport Global... Enanta (ENTA) downgraded to Underweight from Equal Weight at Barclays... FireEye (FEYE) downgraded to Neutral from Outperform at Wedbush... Freescale (FSL) downgraded ahead of deal closing at Bernstein... GNC Holdings (GNC) downgraded to Neutral from Buy at Sterne Agee CRT... Heritage Financial (HFWA) downgraded to Market Perform at Keefe Bruyette... Huron (HURN) downgraded to Underperform from Outperform at Avondale... Independent Bank (IBTX) downgraded to Hold from Buy at Sandler O'Neill... KLX Inc. (KLXI) downgraded at RBC Capital... LaSalle Hotel (LHO) downgraded to Neutral from Outperform at Credit Suisse... LifePoint (LPNT) downgraded to Buy from Conviction Buy at Goldman... Mead Johnson (MJN) downgraded to Neutral from Outperform at Credit Suisse... Mindray Medical (MR) downgraded to Hold from Buy at Deutsche Bank... NASDAQ (NDAQ) downgraded to Market Perform from Outperform at Wells Fargo... Ocular Therapeutix (OCUL) downgraded to Equal Weight from Overweight at Morgan Stanley... Pandora (P) downgraded to Neutral from Buy at BofA/Merrill... Pebblebrook Hotel (PEB) downgraded to Neutral from Outperform at Credit Suisse... Plexus (PLXS) downgraded to Neutral from Buy at Goldman... Quidel (QDEL) downgraded to Hold from Buy at Craig-Hallum... Quotient Technology (QUOT) downgraded to Hold from Buy at Craig-Hallum... Raytheon (RTN) downgraded to Peer Perform from Outperform at Wolfe Research... Safe Bulkers (SB) downgraded to Hold from Buy at Jefferies... Sanmina (SANM) downgraded to Sell from Neutral at Citi... Skechers (SKX) downgraded to Neutral from Buy at Buckingham... Stericycle (SRCL) downgraded to Neutral from Outperform at Baird... Teck Resources (TCK) downgraded to Sell from Hold at Deutsche Bank... Trinity Biotech (TRIB) downgraded to Hold from Buy at Craig-Hallum... USG (USG) downgraded to Hold from Buy at Jefferies... Ultra Clean (UCTT) downgraded to Hold from Buy at Craig-Hallum... Under Armour (UA) downgraded to Hold from Buy at BB&T... Union Pacific (UNP) downgraded to Underperform at Avondale... Vishay (VSH) downgraded to Sell from Neutral at Citi... WABCO (WBC) downgraded to Buy from Conviction Buy at Goldman.
03/04/16
SPHN
03/04/16
NO CHANGE
Target $22
SPHN
Overweight
Trinity Biotech remains top Diagnostics/Life Science Tools idea at Stephens
Stephens analyst Drew Jones said Trinity Biotech remains his favorite idea in the Diagnostics/Life Science Tools space for 2016 in a post-earnings research note. The company second straight quarter of matching consensus earnings expectations has re-established "some much needed credibility" on its execution, according to Jones, looks for an acceleration in organic growth this year. The analyst keeps an Overweight rating and $22 price target on Trinity shares.
04/21/16
ROTH
04/21/16
NO CHANGE
Target $13
ROTH
Buy
Roth Capital remains bullish on long-term Trinity Biotech troponin opportunity
Roth Capital analyst Chris Lewis remains bullish on the long-term Trinity Biotech's troponin opportunity, after the company received the FDA's formal response for its troponin 510k submission, which does not request any extensive additional data. However, the analyst looks for improved underlying growth and profitability trends to materialize to gain higher near-term conviction on the name. Lewis reiterates a Buy rating and $13 price target on the shares.

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