Omeros Corporation Streamlines Path to Biologics License Application for OMS721 in HSCT-TMA Following Meeting with FDA
Omeros Corporation (OMER)
Last omeros corporation earnings: 3/2 04:03 pm
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Source: Business Wire
Patient Data from Existing Single-Arm Study Will Form the Basis for BLA; No Historical Control Required SEATTLE--(BUSINESS WIRE)-- Omeros Corporation (Nasdaq: OMER) today announced that, based on a recent meeting with the U.S. Food and Drug Administration (FDA), the company has streamlined the required work and further advanced its preparations for its Biologics License Application (BLA) for OMS721 in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). OMS721 holds FDA’s breakthrough therapy designation as well as orphan drug designations from FDA and the European Medicines Agency (EMA) for HSCT-TMA. OMS721 is the company’s Phase 3 human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the lectin pathway of the complement system. Agreements reached during the recent FDA meeting are t
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News
- Omeros Corporation to Announce Fourth Quarter and Year-End Financial Results on April 1, 2024Business Wire
- Omeros Co. (NASDAQ: OMER) was downgraded by analysts at StockNews.com from a "hold" rating to a "sell" rating.MarketBeat
- Omeros Corporation Announces Upcoming Presentation Detailing Narsoplimab Compassionate Use in Nine Patients with Hematopoietic Stem Cell Transplant-associated Thrombotic Microangiopathy [Yahoo! Finance]Yahoo! Finance
- Omeros Corporation Announces Upcoming Presentation Detailing Narsoplimab Compassionate Use in Nine Patients with Hematopoietic Stem Cell Transplant-associated Thrombotic MicroangiopathyBusiness Wire
- Omeros Co. (NASDAQ: OMER) was upgraded by analysts at StockNews.com from a "sell" rating to a "hold" rating.MarketBeat
OMER
Earnings
- 11/9/23 - Beat
OMER
Sec Filings
- 3/27/24 - Form SC
- 2/14/24 - Form SC
- 2/13/24 - Form SC
- OMER's page on the SEC website