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OMER

Omeros

$15.20 /

+0.06 (+0.40%)

08:05
07/11/19
07/11
08:05
07/11/19
08:05

Omeros announces agreement with FDA on primary endpoint for narsoplimab trial

Omeros announced agreement with the FDA on the response-based primary endpoint for its pivotal trial to support the biologics license application, or BLA, for narsoplimab to treat hematopoietic stem cell transplant-associated thrombotic microangiopathy, or HSCT-TMA. Narsoplimab is Omeros' human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2. There is no approved product for the treatment or prevention of HSCT-TMA, and narsoplimab is the only drug in development for the treatment of HSCT-TMA to be granted FDA's breakthrough therapy designation. With finalization of the primary endpoint, the next steps for the planned commercialization of narsoplimab for HSCT-TMA are to complete the ongoing data collection from medical records of patients already treated with narsoplimab in the clinical trial or under compassionate use. This will enable preparation of complete patient narratives for inclusion in the clinical sections of the BLA and of the marketing authorization application, or MAA, which is being prepared for submission to the European Medicines Agency, or EMA. No additional patients are needed for submission of the BLA to support approval of narsoplimab in this indication. The company must meet with the program's EMA rapporteurs, scheduled to begin this summer, to refine further the path to European approval. Omeros intends to harmonize the contents of the MAA and BLA. Omeros will also need to complete and submit the BLA and MAA. FDA has previously confirmed that Omeros may submit this BLA on a rolling basis and the company is finalizing for review by FDA its proposed schedule of module submissions under that rolling BLA. As also previously reported, the nonclinical sections of the BLA have been written and are expected to comprise the first module of the BLA submission. EMA does not have a similar rolling submission process.

OMER Omeros
$15.20 /

+0.06 (+0.40%)

05/06/19
Fly Intel: Top five analyst initiations
05/06/19 Cantor Fitzgerald
Omeros initiated with an Overweight at Cantor Fitzgerald
05/06/19 Cantor Fitzgerald
Omeros initiated with an Overweight at Cantor Fitzgerald
10/15/18 H.C. Wainwright
Omeros selloff on data brings attractive entry point, say H.C. Wainwright

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Conagra Brands upgraded to Buy from Hold at Standpoint Research » 14:36
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Wynn Resorts upgraded to Buy from Hold at Standpoint Research » 14:36
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Wynn Resorts

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Cisco upgraded to Buy from Hold at Standpoint Research » 14:36
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Eastman Chemical upgraded to Buy from Hold at Standpoint Research » 14:36
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Eastman Chemical

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Pfizer upgraded to Buy from Hold at Standpoint Research » 14:36
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United Airlines upgraded to Buy from Hold at Standpoint Research » 14:36
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UAL

United Airlines

$66.70 /

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H&R Block upgraded to Buy from Hold at Standpoint Research » 14:35
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Eagle Materials upgraded to Buy from Hold at Standpoint Research » 14:35
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Goodyear Tire upgraded to Buy from Hold at Standpoint Research » 14:35
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AIG upgraded to Buy from Hold at Standpoint Research » 14:35
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Options
TJX put volume heavy and directionally bearish » 14:35
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UPS upgraded to Buy from Hold at Standpoint Research » 14:35
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UPS

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-2.13 (-2.27%)

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Periodicals
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Recommendations
PDUFA date extension 'actually a good sign' for Zogenix, says Piper Sandler » 14:31
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Zogenix

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Hot Stocks
LivaNova jumps after Reorg says Medtronic buyout talks in early stage » 14:29
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LIVN

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$64.31 /

+1.61 (+2.57%)

, MDT

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Shares of LivaNova (LIVN)…

Shares of LivaNova (LIVN) rallied after Reorg, according to Bloomberg, reported that Medtronic is in early stage buyout talks with the company. Medtronic was pitched recently on acquiring LivaNova and the proposal has gained traction, Reorg said, Bloomberg reported. Shares of LivaNova are up 8%, or $5.02, to $67.72 following the report.

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Epic Games to skip GDC 2020 amid coronavirus concerns » 14:28
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Periodicals
LivaNova buyout gained traction at Medtronic, talks early, Reorg says  14:25
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+1.72 (+2.74%)

, MDT

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Reported by Bloomberg.

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Options
BNY Mellon call volume above normal and directionally bullish » 14:25
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BK

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Bullish option flow…

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Periodicals
Medtronic pitched LivaNova buyout recently, Reorg says, Bloomberg reports  14:24
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LIVN

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$64.42 /

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Recommendations
JMP reiterates $191 price target on Esperion after second FDA approval » 14:20
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JMP Securities analyst…

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Technical Analysis
NASDAQ market internals summary » 14:17
02/27/20
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$NSD

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$0.00 /

+ (+0.00%)

Volume is above average…

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Recommendations
Loop Capital keeps $15 target on L Brands after 'disappointing' guidance » 14:16
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LB

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+0.35 (+1.54%)

Loop Capital analyst…

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Technical Analysis
NYSE market internals summary » 14:16
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$NYE

NYSE Market Internals

$0.00 /

+ (+0.00%)

Volume is above average…

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Periodicals
FCC to fine mobile carriers for failing to safeguard users' data, WSJ says » 14:15
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, S

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$9.41 /

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In recent weeks, the…

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