Omeros Corporation OMER announced that the FDA has extended the review period of a biologics license application (“BLA”) for its lead MASP-2 inhibitor, narsoplimab, by three months. The BLA is seeking approval for narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA).
As a result, the regulatory body will now announce its decision on Oct 17, 2021, instead of the previously anticipated Jul 17, 2021. The extension of the review period is due to additional time required by the FDA for the review.
Shares of Omeros were down 10.7% on Thursday following the announcement of the news. However, the stock has increased 6% so far this year compared with the industry’s rise of 2.4%.
We remind investors, that in January 2021, the BLA for narsoplimab in HSCT-TMA was accepted for filing under the FDA’s Priority Review program.
Per the press release, the company has submitted a response to an FDA information request, which is part of the ongoing BLA Priority Review. The regulatory body classified the response as a major amendment which will require additional time to review.
Currently there is no approved treatment available for HSCT-TMA. Narsoplimab is the first candidate submitted to the FDA for approval for the given indication. Narsoplimab already enjoys a Breakthrough Therapy and Orphan designations to treat HSCT-TMA.
If approved for HSCT-TMA, narsoplimab can lend a big boost to the company’s growth prospects in the days ahead.
We note that narsoplimab is also being evaluated in several late-stage studies for other complement-mediated disorders, including IgA nephropathy, atypical hemolytic uremic syndrome and COVID-19. The candidate also enjoys an Orphan and Breakthrough Therapy designation to treat IgA nephropathy.
Zacks Rank & Stocks to Consider
Omeros currently carries a Zacks Rank #4 (Sell).
Better-ranked stocks in the healthcare sector include Athenex, Inc. ATNX, Avid Bioservices, Inc. CDMO and Adaptive Biotechnologies Corporation ADPT, all carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Athenex’s loss per share estimates have narrowed 21.8% for 2021 and 23.2% for 2022 over the past 60 days.
Avid Bioservices’ earnings estimates have been revised 80% upward for 2021 and 53.8% upward for 2022 over the past 60 days. The stock has soared 74.1% year to date.
Adaptive Biotechnologies’ loss per share estimates have narrowed 11.7% for 2021 and 2.3% for 2022 over the past 60 days.
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