The opinions expressed in this article are those of the writer, subject to the Publishing Guidelines. On the date of publication, Chris MacDonald did not have (either directly or indirectly) any positions in the securities mentioned in this article. While a final decision on the information under review has not yet been given, this is not a good sign.Īccordingly, it appears investors are erring on the side of caution today. 17 target date specified under the Prescription Drug User Fee Act. However, the key issue investors are pricing in is the fact that as a result of this notification, Omeros is unlikely to meet the Oct. Omeros has stated the company is awaiting next steps for this drug. Additionally, both parties are working toward resolving this issue. The company notes that the FDA approved the BLA for Narsoplimab earlier this year under the Priority Review program. Should You Buy OMER 14891.50 31.75 (0.21) Dow Jones Futures. However, the degree to which the selloff represents the true long-term impact of today’s announcement remains to be seen.Īll hope is not yet lost for Omeros’ hematopoietic stem cell transplant-associated thrombotic microangiopathy (that’s a mouthful). Indeed, today’s 40% decline represents the level of risk various biopharma stocks present. Omeros Corporation (OMER) NasdaqGM - NasdaqGM Real Time Price. Today, Omeros announced that the Food and Drug Administration (FDA) has noted deficiencies with Narsoplimab that “ preclude discussion of post-marketing requirements/commitments at this time.” In other words, the commercialization prospects and timeline for this drug remain uncertain right now.Īny company that gets this close to the final approval stage, only to have the rug pulled, is likely to see a selloff. Omeros Corporation (OMER) NasdaqGM - NasdaqGM Real Time Price.
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