• Connect with us
    • Information
      • About Us
      • Contact Us
      • Careers
      • Partnerships
      • Advertise With Us
      • Authors
      • Browse Topics
      • Events
      • Disclaimer
      • Privacy Policy
    • NORTH AMERICA EDITION
      Australia
      North America
      World
    Login
    Investing News NetworkYour trusted source for investing success
    • NORTH AMERICA EDITION
      North America
      Australia
      World
    • My INN
    Videos
    Companies
    Press Releases
    Private Placements
    SUBSCRIBE
    • Reports & Guides
      • Market Outlook Reports
      • Investing Guides
    • Button
    Resource
    • Precious Metals
    • Battery Metals
    • Base Metals
    • Energy
    • Critical Metals
    Tech
    Life Science
    Life Science Market
    Life Science News
    Life Science Stocks
    • Life Science Market
    • Life Science News
    • Life Science Stocks

    Spectrum Pharmaceuticals Shares Plummet After Receiving Complete Response Letter from FDA

    Morag Mcgreevey
    Oct. 23, 2015 12:14PM PST
    Life Science Investing News

    Spectrum Pharmaceuticals (NASDAQ:SPPI) stock dropped over 20%, after the company announced that it received a Complete Response Letter from the the US Food and Drug Administration relating to its EVOMELA injection drug.

    Spectrum Pharmaceuticals (NASDAQ:SPPI) stock dropped over 20%, after the company announced that it received a Complete Response Letter from the the US Food and Drug Administration relating to its EVOMELA injection drug.
    According to a press release:

    Shares in Spectrum Pharmaceuticals (“Spectrum” or the “Company”) (NASDAQ: SPPI) have plunged over 20% today after the company announced that it received a Complete Response Letter from the United States Food and Drug Administration (“FDA”) related to the company’s EVOMELA injection drug. An FDA Complete Response Letter informs companies that the FDA cannot approve a new drug application as submitted.
    In the months prior to today’s news, the Company and its officers made numerous statements about EVOMELA, including statements reflecting the company’s belief that the pending application before the FDA would be successful, and that EVOMELA would contribute to Spectrum’s revenue in late 2015. As such, the FDA’s Complete Response Letter came as a complete surprise to investors.
    Block & Leviton LLP is investigating the Company and certain of its officers and directors to learn the facts behind the company’s EVOMELA application, its statements about the drug’s approval process, and the FDA’s subsequent rejection of the company’s new drug application. The firm is also investigating whether any insiders at Spectrum profited from alleged misstatements made about EVOMELA in the weeks and months prior to today’s announcement.

    Click here to read the full press release.

     

    new drug applicationunited statesfood and drug administrationresponse letter
    The Conversation (0)

    Go Deeper

    AI Powered
    Medical pills branded with Canadian flag.

    Canadian Pharma Stocks: 5 Biggest Companies

    Scientist with petri dish.

    Pharma Market Forecast: Top Trends for Pharma in 2025

    Latest News

    Outlook Reports

    Resource
    • Precious Metals
      • Gold
      • Silver
    • Battery Metals
      • Lithium
      • Cobalt
      • Graphite
    • Energy
      • Uranium
      • Oil and Gas
    • Base Metals
      • Copper
      • Nickel
      • Zinc
    • Critical Metals
      • Rare Earths
    • Industrial Metals
    • Agriculture
    Tech
      • Artificial Intelligence
      • Cybersecurity
      • Gaming
      • Cleantech
      • Emerging Tech
    Life Science
      • Biotech
      • Cannabis
      • Psychedelics
      • Pharmaceuticals

    Featured Stocks

    More featured stocks

    Browse Companies

    Resource
    • Precious Metals
    • Battery Metals
    • Energy
    • Base Metals
    • Critical Metals
    Tech
    Life Science
    MARKETS
    COMMODITIES
    CURRENCIES
    ×