Omeros Corporation Initiates BLA Submission for Narsoplimab for the Treatment of HSCT-TMA
Omeros Corporation (OMER)
Last omeros corporation earnings: 3/2 04:03 pm
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Source: Business Wire
– Rolling Submission of the Remaining BLA Sections Continues On Track for Scheduled Completion 1H 2020 – SEATTLE--(BUSINESS WIRE)--Omeros Corporation (Nasdaq: OMER) has submitted the first sections of the rolling submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA), a far-too-often deadly complication of stem-cell transplantation.Narsoplimab, also known as “OMS721,” is Omeros’ lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2). There currently 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 with FDA’s breakthrough therapy designation. Narsoplimab also has been granted FDA’s orphan drug designation for this indication.Last month, Omeros announced that FDA had agreed with
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News
- When Can We Expect A Profit From Omeros Corporation (NASDAQ:OMER)? [Yahoo! Finance]Yahoo! Finance
- Omeros Co. (NASDAQ: OMER) is now covered by analysts at D. Boral Capital. They set a "buy" rating and a $36.00 price target on the stock.MarketBeat
- Omeros Co. (NASDAQ: OMER) had its "hold" rating re-affirmed by analysts at Needham & Company LLC.MarketBeat
- Omeros Reports Narsoplimab TA-TMA Trial Success; Stock Surges [Yahoo! Finance]Yahoo! Finance
- Omeros’ Narsoplimab Meets its Pivotal Trial Primary Endpoint – Statistical Analysis Shows Survival Superiority Over External Control in Patients with TA-TMABusiness Wire
OMER
Earnings
- 5/15/24 - Miss
OMER
Sec Filings
- 12/19/24 - Form 8-K
- 11/13/24 - Form 10-Q
- 11/13/24 - Form 8-K
- OMER's page on the SEC website