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July 31, 2014
14:41 EDTLMNX, DGX, LH, PACB, ILMN, VCYT, SQNM, QGEN, MYGN, GHDXFDA draft lab tests guidelines not as bad as feared, says Piper Jaffray
After the FDA announced it intends to issue draft guidance on regulations for lab developed tests, Piper Jaffray said the proposed guidelines appear "less onerous" than the firm initially expected. Piper added that the FDA intends to leverage existing studies in lieu of requiring additional studies, which the firm views as positive for companies with well validated offerings such as Genomic Health (GHDX), Myriad Genetics (MYGN), QIAGEN (QGEN), Sequenom (SQNM), and Veracyte (VCYT).
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November 27, 2015
10:44 EDTMYGNCMS may have made mistake with Myriad BRCA pricing, says Piper Jaffray
Piper Jaffray analyst William Quirk noted that the Centers for Medicare and Medicaid Services, or CMS, released the final 2016 Clinical Diagnostic Laboratory Fee Schedule yesterday, which showed Myriad Genetics' BRCA1/2 sequencing and full duplication/deletion analysis priced at $1,839.54, down from the $2,483.37 listed in the preliminary and final CLFS determination documents. Quirk said this may be an error and that he anticipates CMS to issue a correction and/or Myriad to file an appeal in the near-term. The analyst keeps an Overweight rating on Myriad shares.
November 23, 2015
05:36 EDTGHDX, MYGNGenomic Health upgraded to Buy from Neutral at UBS
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November 20, 2015
07:56 EDTILMNIllumina has a path back to $200 per share, says Cowen
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November 19, 2015
16:27 EDTLHGlenview Capital Management reports 5.29% passive stake in LabCorp
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10:00 EDTGHDXOn The Fly: Analyst Upgrade Summary
Today's noteworthy upgrades include: Dick's Sporting (DKS) upgraded to Buy from Neutral at Monness Crespi... Fairchild (FCS) upgraded to Neutral from Underperform at Credit Suisse... Fiesta Restaurant (FRGI) upgraded to Strong Buy from Outperform at Raymond James... General Dynamics (GD) upgraded to Buy from Hold at Argus... Genomic Health (GHDX) upgraded to Outperform from Market Perform at Cowen... National Grid (NGG) upgraded to Outperform from Sector Perform at RBC Capital... ON Semiconductor (ON) upgraded to Buy from Neutral at Citi... Papa John's (PZZA) upgraded to Buy from Neutral at Sidoti... QEP Resources (QEP) upgraded to Buy from Neutral at Goldman... Seagate (STX) upgraded to Buy on selloff, dividend yield at Craig-Hallum... Sunoco (SUN) upgraded to Outperform at Credit Suisse... Tetraphase (TTPH) upgraded to Buy from Neutral at SunTrust... Wendy's (WEN) upgraded to Conviction Buy from Neutral at Goldman.
08:17 EDTGHDXGenomic Health upgraded to Outperform from Market Perform at Cowen
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07:19 EDTMYGNCMS decision a big positive for Myriad Genetics, says Stephens
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07:14 EDTVCYTCMS decision removes potential headwind for Veracyte, says Stephens
Stephens analyst Drew Jones noted that an updated CLFS with 2016 determinations released by CMS suggests a change to gap fill pricing for Veracyte's Afirma GEC test, removing what could have been a significant headwind heading into 2016. Jones maintains his Overweight rating and $14 price target on Veracyte shares.
November 18, 2015
09:49 EDTMYGNCMS reversal removes 'huge overhang' for CareDx, says Mizuho
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November 17, 2015
20:06 EDTVCYTVeracyte applauds CMS decision to use 'gapfill' pricing for Afirma
Veracyte issued a statement in response to the Centers for Medicare and Medicaid Services', or CMS, decision to use a "gapfill" approach to pricing the Afirma Gene Expression Classifier, or GEC. CMS's final decision was published in its 2016 Clinical Laboratory Fee Schedule, or CLFS, Final Determinations and reverses the agency's previous proposal to "crosswalk" the price of the Afirma GEC to that of a very different test, which would have resulted in a lower 2016 Medicare reimbursement rate for the Afirma GEC. "We applaud CMS for its decision, which we believe recognizes the unique nature of the Afirma GEC, including its unmatched ability to rule out cancer in thyroid nodules that are deemed inconclusive following initial, traditional evaluation," said Veracyte CEO Bonnie Anderson. "Today's decision is a victory for precision medicine and the many patients who are benefitting from it. We estimate that the Afirma GEC, for example, has helped tens of thousands of patients avoid unnecessary thyroid surgery and its potential aftermath, while avoiding millions of dollars of unnecessary healthcare spending."
November 13, 2015
16:24 EDTILMNOn The Fly: Top stock stories for Friday
Stocks on Wall Street ended a tough week on a down note, falling after the Commerce Department reported that retail sales grew by an anemic 0.1% last month. This data comes on the heels of this week's downbeat quarterly report from Macy's (M) and a similarly disappointing report last night from peer Nordstrom (JWN). ECONOMIC EVENTS: In the U.S., retail sales rose 0.1% in the month of October, versus expectations for an increase of 0.3%. When autos and gas are removed, the core reading was up 0.3%, versus expectations for a rise of 0.4%. Producer prices fell 0.4%, versus expectations for them to be up 0.2%. When food and energy are removed, the core reading was down 0.3%, versus expectations for it to be up 0.1%. Business inventories grew 0.3% in September while sales were flat compared to August. Consumer sentiment, as measured by the preliminary print from the University of Michigan survey, improved 3.1 points to 93.1 in November, which was better than the 91.5 reading that was expected. In Europe, data showed that eurozone's economy grew by just 0.3% in the third quarter, which was a slowdown from the 0.4% GDP growth recorded three months earlier and weaker than the 0.4% consensus growth forecast. COMPANY NEWS: Shares of retailers broadly declined following the weaker than expected retail sales data reported by the government as well as third quarter earnings reports from Nordstrom and J.C. Penney (JCP), which fell 15% and 15.5% respectively. Virtually every mass-market, brick-and-mortar retailer was down today, from giants like Wal-Mart (WMT) and Costco (COST), to smaller retailers like Ross Stores (ROST) and Urban Outfitters (URBN)... Shares of Mylan (MYL) jumped 12.9% to $48.78 after the company's offer to acquire Perrigo (PRGO) failed, ending a seven-month fight between the two drug makers. Perrigo Chief Executive Officer Joseph Papa said he was "delighted" that his company's shareholders rejected the offer and the company added that it will immediately commence its previously announced $2B share buyback program, but its shares slid 6.16% to $146.90 in the wake of the shareholder vote... Cisco (CSCO) fell 5.8% after its first quarter earnings and revenue beat expectations but its guidance for the new quarter disappointed. A number of analysts that had been bullish on the name trimmed their price targets in response but also recommended the post-earnings weakness as a buying opportunity. MAJOR MOVERS: Among the notable gainers was Springleaf Holdings (LEAF), which surged $5.07, or 11.5%, to $49.27 after reaching a settlement with the U.S. Department of Justice that will allow the company to proceed with closing its previously announced acquisition of OneMain Financial from Citi (C). On the closing of the acquisition, the company will be renamed OneMain Holdings and has applied to the New York Stock Exchange to change its ticker symbol to "OMF," Springleaf noted. Also higher was Illumina (ILMN), which gained $10.26, or 6.6%, to $165.65 after being selected to replace Sigma-Aldrich (SIAL) in the S&P 500. Among the noteworthy losers was Fossil (FOSL), which plunged $18.62, or 36.5%, to $32.39 after the watchmaker gave lower than expected profit guidance for the upcoming quarter and said it continues to expect this fiscal year's results to be "significantly" negatively impacted by foreign currency changes. Also lower were shares of Vipshop (VIPS), which fell $5.03, or 27%, to $13.60 after issuing weaker than expected preliminary third quarter revenue guidance, which it said was partially driven by the warmer-than-expected fall weather in China. INDEXES: The Dow dropped 202.83, or 1.16%, to 17,245.24, the Nasdaq lost 77.20, or 1.54%, to 4,927.88, and the S&P 500 declined 22.93, or 1.12%, to 2,023.04.

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