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OMER.US
id: 990, Created by , Scout

Omeros Corporation (OMER) Delay in Drug Development Case

  • In October 2021, Omeros (OMER) announced that FDA found deficiencies in Company’s license application for a drug candidate, not expected to be resolved by the legally prescribed date.
  • On it, $OMER fell 38%, losing $330M+ of shareholder value.
  • Investors may have grounds to suspect that Omeros has faulty drug development process causing regulatory setbacks, which led to their losses.
On October 1, 2021, Omeros announced that the FDA had identified deficiencies with the Company’s Biologics License Application for its drug candidate narsoplimab.
  • Omeros further announced that these deficiencies precluded discussion of labeling and post-marketing requirements/commitments at that time.
  • Omeros also stated that it didn’t expect to resolve the issues by target action date under the Prescription Drug User Fee Act (PDUFA).
On this news, $OMER fell 38% and lost over $330 million of its market capitalization, seriously damaging shareholders.

Considering all the information, investors might have grounds to suspect that Omeros failed to timely disclose company’s regulatory setbacks, which consequently led to their losses.

The case is already under investigation by at least one of the reputable law firms.
Alleged Offence
Misleading Statements
Failure to Disclose
Omissions
Suspected Party
Directors
Management
Security Type
Stocks
Trade Direction
Long
Shock Event Date
01 October 2021
Collecting participants…

Omeros Corporation

Omeros Corporation, a clinical-stage biopharmaceutical company, discovers, develops, and commercializes small-molecule and protein therapeutics, and orphan indications targeting inflammation, compl...

    Ticker
    OMER.US
    ISIN
    US6821431029
    CIK
    1285819
    Sector
    Healthcare
    Industry
    Biotechnology
    Country
    USA
    Address
    The Omeros Building, Seattle, WA, United States, 98119