Register Login

SIGA Technologies Inc (SIGA)

  • Event
  • July 12, 2022, 20:15 UTC

(10% Negative) SIGA TECHNOLOGIES, INC. (SIGA) Announces Delay in made Trials for oral TPOXX® (tecovirimat) Due to Pandemic-Related Challenges, Regulatory Process, Manufacturing Considerations, Safety Review

Full text
Register to leave comments
  • News bot Oct. 2, 2025, 1:08 p.m.

    📋 SIGA TECHNOLOGIES, INC. (SIGA) - Clinical Trial Update

    Filing Date: 2022-07-12

    Accepted: 2022-07-12 16:15:29

    Event Type: Clinical Trial Update

    Event Details:

    SIGA Technologies Inc (SIGA) Announces Clinical Trial Update SIGA Technologies Inc (SIGA) provided an update on its clinical development programs. Clinical Development Highlights:
    • Drug Program: made, million
    • Diseases/Conditions: oral TPOXX® (tecovirimat), Europe
    • Update Type: Trial Timeline Adjustment
    • Primary Factors: Pandemic-Related Challenges, Regulatory Process
    • Collaboration: DND
      • anticipated by such forward-looking statements due to a number of factors, some of which are beyond SIGA’s control, including, but not limited to, (i) the risk that the U.S. Biomedical Advanced Research and Development Authority (“BARDA”) elects, in its sole discretion as permitted under the BARDA Contracts (as defined below), not to exercise all, or any, of the remaining unexercised options under those contracts, (ii) the risk that SIGA may not complete performance under its contracts with BARDA (the “BARDA Contracts”) on schedule or in accordance with contractual terms, (iii) the risk that the BARDA Contracts are modified or canceled at the request or requirement of the U.S. government, (iv) the risk that the nascent international biodefense market does not develop to a degree that allows SIGA to successfully market TPOXX internationally, (v) the risk that potential products, including potential alternative uses or formulations of TPOXX that appear promising to SIGA or its collaborators, cannot be shown to be efficacious or safe in subsequent pre-clinical or clinical trials, (vi) the risk that SIGA or its collaborators will not obtain appropriate or necessary governmental approvals to market these or other potential products or uses, (vii) the risk that SIGA may not be able to secure or enforce sufficient legal rights in its products, including intellectual property protection, (viii) the risk that any challenge to SIGA’s patent and other property rights, if adversely determined, could affect SIGA’s business and, even if determined favorably, could be costly, (ix) the risk that regulatory requirements applicable to SIGA’s products may result in the need for further or additional testing or documentation that will delay or prevent SIGA from seeking or obtaining needed approvals to market these products, (x) the risk that the volatile and competitive nature of the biotechnology industry may hamper SIGA’s efforts to develop or market its products, (xi) the risk that changes in domestic or foreign economic and market conditions may affect SIGA’s ability to advance its research or may affect its products adversely, (xii) the effect of federal, state, and foreign regulation, including drug regulation and international trade regulation, on SIGA’s businesses, (xiii) the risk that the COVID-19 pandemic could impact SIGA’s operations by disrupting SIGA’s supply chain for the manufacture of TPOXX, causing delays in SIGA’s research and development activities, causing delays or the re-allocation of funding in connection with SIGA’s government contracts, or diverting the attention of government staff overseeing SIGA’s government contracts, (xiv) the risk that the U.S. or foreign governments’ responses (including inaction) to national or global economic conditions or infectious diseases such as COVID-19 are ineffective and may affect SIGA’s business adversely, and (xv) other risk factors discussed in Item 1A. “Risk Factors” of SIGA’s Annual Report on Form 10-K for the year ended December 31, 2021

    💼 Business Developments:

    • Partnership: Not available
    • Acquisition: Not available
    • Licensing: Not available
    • Regulatory Approval
    • Executive Changes: Not available

    Structured Data:

    • Company Name: SIGA Technologies Inc
    • CIK: 0001010086
    • Ticker Symbol: SIGA
    • Period End Date: 2022-07-12
    • Document Type: 8-K

Search

News categories