U.S. markets closed
  • S&P 500

    4,402.66
    -20.49 (-0.46%)
     
  • Dow 30

    34,792.67
    -323.73 (-0.92%)
     
  • Nasdaq

    14,780.53
    +19.24 (+0.13%)
     
  • Russell 2000

    2,198.41
    -25.17 (-1.13%)
     
  • Crude Oil

    67.95
    -2.61 (-3.70%)
     
  • Gold

    1,814.60
    +0.50 (+0.03%)
     
  • Silver

    25.44
    -0.14 (-0.54%)
     
  • EUR/USD

    1.1846
    -0.0022 (-0.19%)
     
  • 10-Yr Bond

    1.1840
    +0.0080 (+0.68%)
     
  • GBP/USD

    1.3882
    -0.0033 (-0.24%)
     
  • USD/JPY

    109.4470
    +0.3970 (+0.36%)
     
  • BTC-USD

    39,804.59
    +1,784.88 (+4.69%)
     
  • CMC Crypto 200

    979.50
    +52.73 (+5.69%)
     
  • FTSE 100

    7,123.86
    +18.14 (+0.26%)
     
  • Nikkei 225

    27,584.08
    -57.75 (-0.21%)
     

Omeros' (OMER) BLA for Narsoplimab Gets Extended Review

·3 min read

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%.

price chart for OMER
price chart for OMER


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.

More Stock News: This Is Bigger than the iPhone!

It could become the mother of all technological revolutions. Apple sold a mere 1 billion iPhones in 10 years but a new breakthrough is expected to generate more than 77 billion devices by 2025, creating a $1.3 trillion market.

Zacks has just released a Special Report that spotlights this fast-emerging phenomenon and 4 tickers for taking advantage of it. If you don't buy now, you may kick yourself in 2022.

Click here for the 4 trades >>


Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report

Omeros Corporation (OMER) : Free Stock Analysis Report

Adaptive Biotechnologies Corporation (ADPT) : Free Stock Analysis Report

Athenex, Inc. (ATNX) : Free Stock Analysis Report

Avid Bioservices, Inc. (CDMO) : Free Stock Analysis Report

To read this article on Zacks.com click here.

Zacks Investment Research