OMER - Here's why Omeros Corp shares are down 40% on Friday morning

The U.S. FDA notified Omeros Corporation ( NASDAQ: OMER ) that it identified deficiencies in the company’s marketing application for Narsoplimab, Omeros disclosed in a press release this morning.

Shares of the company tanked more than 40% on Friday.

FDA refrained from divulging details of the deficiencies

Narsoplimab is a treatment for hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). Identified deficiencies, the regulator added, “preclude discussion of labelling and post-marketing requirements/commitments at this time”.

Omeros’ Biologics License Application (BLA) for Narsoplimab was accepted at the start of this year in January under the U.S. drug regulator’s “Priority Review” program.

The Food and Drug Administration refrained from divulging details of the deficiencies but said it wanted to work with Omeros to settle issues as quickly as possible. It also clarified that the review was still ongoing, and the notification should not be seen as its final verdict.

Omeros doesn’t expect a resolution by October 17th

Omeros, however, says any such resolution was unlikely to come by October 17 ^th – its target action date under the PDUFA (Prescription Drug User Fee Act). The press release read:

Omeros is evaluating potential next steps as it awaits additional information from FDA and plans to obtain FDA approval for Narsoplimab in HSCT-TMA as quickly as possible.

Narsoplimab is the pioneer candidate drug for HSCT-TMA submitted to the U.S. drug regulator for approval.

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