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OMER

Omeros

$18.49

0.49 (2.72%)

09:27
09/11/19
09/11
09:27
09/11/19
09:27

Omeros announces FDA confirms schedule for rolling review of narsoplimab BLA

Omeros announced that the FDA agreed with the company's proposed schedule for the rolling review of the Biologics License Application, or BLA, for narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy, or HSCT-TMA. Consistent with the agreed schedule, the company is on track to submit the BLA's first sections, which will include the nonclinical and clinical pharmacology data, in the first half of next quarter. Under its rolling review process, FDA can review components of a marketing application as they are submitted rather than requiring all components to be received prior to initiating review, allowing faster review of the application. The BLA for narsoplimab, because of the drug's breakthrough therapy designation from FDA for the treatment of HSCT-TMA, is also eligible for priority review, which shortens the standard FDA review cycle by four months.

OMER Omeros
$18.49

0.49 (2.72%)

10/15/18
HCWC
10/15/18
NO CHANGE
Target $34
HCWC
Buy
Omeros selloff on data brings attractive entry point, say H.C. Wainwright
Data released earlier this month from a Phase 2 trial of OMS721, Omeros's most advanced clinical candidate, appear to have created some confusion in the market as the company's share price has fallen roughly 50% since the announcement, H.C. Wainwright analyst Raghuram Selvaraju tells investors in a research note. The selloff is unwarranted, says the analyst, who reiterates a Buy rating on the shares with a $34 price target. He points out that the data were from a small trial that was not designed to deliver statistical significance or definitive evidence of efficacy. Further, the "data itself were encouraging, not discouraging, and there certainly was no evidence of any safety concern or toxicity issue that would have jeopardized OMS721's future development," Selvaraju writes.
05/06/19
CANT
05/06/19
INITIATION
CANT
Overweight
Omeros initiated with an Overweight at Cantor Fitzgerald
Cantor Fitzgerald initiated Omeros with an Outperform and $26 price target.
05/06/19
CANT
05/06/19
INITIATION
Target $26
CANT
Overweight
Omeros initiated with an Overweight at Cantor Fitzgerald
Cantor Fitzgerald analyst Brandon Folkes initiated coverage of Omeros with an Overweight rating and $26 price target. The analyst believes investors can be rewarded from current levels through the company's pipeline alone. As such, the risk/reward is to the upside, "creating a compelling investment opportunity," Folkes tells investors in a research note.
05/06/19
05/06/19
INITIATION

Fly Intel: Top five analyst initiations
Catch up on today's top five analyst initiations with this list compiled by The Fly: 1. PagerDuty (PD) initiated with an Overweight at Piper Jaffray, with a Neutral at BTIG, with an Outperform at William Blair, with an Overweight at JPMorgan, with a Sector Weight at KeyBanc, with an Equal Weight at Morgan Stanley and with a Sector Perform at RBC Capital. 2. Tufin (TUFN) initiated with a Buy at Jefferies, with an Overweight at Piper Jaffray, with a Market Perform at William Blair, with a Hold at Stifel, with an Outperform at Oppenheimer, with an Overweight at JPMorgan and with an Overweight at Barclay. 3. Aclaris Therapeutics (ACRS) initiated with an Outperform at SVB Leerink. 4. Jumia Technologies (JMIA) initiated with a Neutral at Citi and with a Sector Perform at RBC Capital. 5. Omeros (OMER) initiated with an Overweight at Cantor Fitzgerald. This list is just a portion of The Fly's full analyst coverage. To see The Fly's full Street Research coverage, click here.

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