Omeros Corporation Provides Update on Progress Toward BLA Resubmission
Omeros Corporation (OMER)
Last omeros corporation earnings: 3/2 04:03 pm
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Source: Business Wire
SEATTLE--(BUSINESS WIRE)--Omeros Corporation (Nasdaq: OMER) today announced an update on its progress toward planned resubmission of its biologics license application (“BLA”) for narsoplimab, the company’s first-in-class antibody targeting MASP-2, the effector enzyme of the lectin pathway of complement, in hematopoietic stem cell transplant-associated thrombotic microangiopathy (“TA-TMA”). In last week’s quarterly earnings release and associated call, Omeros stated that it was awaiting feedback from the U.S. Food and Drug Administration (“FDA”) on the company’s revised statistical analysis plan (“SAP”) for the BLA. Omeros has now received FDA’s response on the revised SAP, has no other presubmission information requests pending and is not aware of any other impediment to resubmitting the narsoplimab BLA. Following data preparation, primary endpoint and other analyses will be conducted by an independent expert statistical group. If the analytical results support resubmission of the
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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’ Narsoplimab Meets its Pivotal Trial Primary Endpoint – Statistical Analysis Shows Survival Superiority Over External Control in Patients with TA-TMABusiness Wire
- 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
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