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Bionovo Announces Third Quarter 2010 Highlights and Financial Results
Date:11/11/2010

EMERYVILLE, Calif., Nov. 11, 2010 /PRNewswire-FirstCall/ -- Bionovo, Inc. (Nasdaq: BNVI), a pharmaceutical company focused on the discovery and development of safe and effective treatments for women's health and cancer, today announced third quarter highlights and financial results for the three months ended September 30, 2010. The company also announced that it had positively concluded a key regulatory meeting with the U.S. Food and Drug Administration (FDA) and was proceeding with preparations for pivotal testing of Menerba, the company's drug candidate for menopausal hot flashes.

"We now have a clear path forward from the FDA and the EMA, with approved CMC packages and complete clinical development plans. We are moving forward with Menerba as expeditiously as possible," said Isaac Cohen, Bionovo's Chairman and Chief Executive Officer. "This gives us, and any potential partner, the last piece in the regulatory puzzle."

Over the past quarter, the company accomplished the following:Key Events To Date

  • The Company held an anticipated meeting with the U.S. Food and Drug Administration (FDA) on the clinical development plan for Menerba in the U.S. Earlier, the Company had a meeting with the FDA regarding Menerba's Chemistry, Manufacturing and Controls (CMC) package, wherein the FDA approved Menerba's CMC plan. "With agreements on both the clinical development and the CMC requirements, with both the FDA and the EMA, we are confident we can now satisfy the regulatory requirements for bringing Menerba to market," said Dr. Isaac Cohen.


  • The Company received notification that it had two projects approved for funding at the maximum level under the Qualifying Therapeutic Discovery Project Credit ("QTDP")  program.  Bionovo expects to receive the maximum level allowable under the program for its Menerba
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  • SOURCE Bionovo, Inc.
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    Related medicine technology :

    1. Bionovo, Inc. to Announce Third Quarter Fiscal Year 2010 Financial Results on Thursday, November 11, 2010
    2. Bionovo Announces Publication Describing Potential Estrogen Receptor Modulating Drugs for Treating Menopausal Conditions
    3. Bionovo to Raise $3 Million Through Registered Direct Offering
    4. Bionovo to Present at the JMP Securities Healthcare Conference
    5. Bionovo to Present at Cambria Capital Investor Meeting
    6. Bionovo Receives Positive Guidance from FDA on Menerba®
    7. Bionovo Announces Reverse Stock Split
    8. Bionovo Announces Publication Describing Menerbas Effect on Neural Pathways Related to Temperature Regulation
    9. Bionovo to Advance Menerba to Phase 3 Clinical Testing in Europe
    10. Bionovo, Inc. to Announce Second Quarter Fiscal Year 2010 Financial Results on Wednesday, August 4, 2010
    11. Bionovo Announces a $15 Million At-The-Market Firm Commitment Financing Agreement
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