Omeros Corporation Provides Update on Progress Toward BLA Resubmission [Yahoo! Finance]
Omeros Corporation (OMER)
Last omeros corporation earnings: 3/2 04:03 pm
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Source: Yahoo! Finance
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 BLA, the company plans to finalize and resubmit the BLA as soon as possible. As previously disclosed, as part of a September 2024 m
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News
- Omeros Corporation Provides Update on Progress Toward BLA ResubmissionBusiness Wire
- Omeros Co. (NASDAQ: OMER) was upgraded by analysts at StockNews.com from a "sell" rating to a "hold" rating.MarketBeat
- Omeros Co. (NASDAQ: OMER) was upgraded by analysts at RODMAN&RENSHAW to a "strong-buy" rating.MarketBeat
- Omeros Co. (NASDAQ: OMER) had its "neutral" rating re-affirmed by analysts at Cantor Fitzgerald.MarketBeat
- Omeros Co. (NASDAQ: OMER) had its "hold" rating re-affirmed by analysts at Needham & Company LLC.MarketBeat
OMER
Earnings
- 5/15/24 - Miss
OMER
Sec Filings
- 11/13/24 - Form 10-Q
- 11/13/24 - Form 8-K
- OMER's page on the SEC website