Omeros’ Narsoplimab Meets its Pivotal Trial Primary Endpoint – Statistical Analysis Shows Survival Superiority Over External Control in Patients with TA-TMA
Omeros Corporation (OMER)
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Source: Business Wire
Primary statistical analysis of overall survival compared TA-TMA patients treated with narsoplimab in its pivotal trial to a cohort of over 100 TA-TMA patients not treated with narsoplimab in an external control stem cell transplant registry; FDA-agreed analysis was conducted by an independent external statistical groupNarsoplimab-treated TA-TMA patients had an over 3-fold reduction in risk of mortality (hazard ratio = 0.32 [95% confidence interval: 0.23, 0.44]; p Omeros is preparing and will resubmit a BLA to FDA for narsoplimab to become the first approved therapeutic for TA-TMA, a life-threatening complication of hematopoietic stem cell transplantation SEATTLE--(BUSINESS WIRE)--Omeros Corporation (Nasdaq: OMER) today announced that an independent statistical group has completed the primary statistical analysis agreed with the FDA for narsoplimab, Omeros’ first-in-class monoclonal antibody inhibiting the lectin pathway of complement, in the treatment of hematopoietic stem cell tr
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News
- 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 Corporation Announces Presentation of Positive Zaltenibart Data at ASH Annual Meeting [Yahoo! Finance]Yahoo! Finance
- Omeros Corporation Announces Presentation of Positive Zaltenibart Data at ASH Annual MeetingBusiness Wire
- Omeros Corporation Announces Upcoming Presentations at ASH Annual MeetingBusiness Wire
OMER
Earnings
- 5/15/24 - Miss
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- 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