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Vir Biotech Shuns FDA Submission Plans For GSK-Partnered COVID-19 Treatment

  • In its Q2 earnings releaseVir Biotechnology Inc (NASDAQ: VIR) and its partner GSK plc (NYSE: GSK) said that they do not plan to file a marketing application for sotrovimab for COVID-19 at this time.

  • The company also said it does not intend to pursue the US-based Phase 3 COMET-STAR prophylaxis trial, citing evolving COVID-19 landscape and FDA discussions.

  • Discussions with the FDA remain ongoing regarding the appropriate path forward for sotrovimab in the U.S.

  • Related: Why Did FDA Pull Authorization For GSK-Vir's COVID-19 Therapy? Read Here.

  • In Q2, approximately 265,000 sotrovimab doses were delivered, all outside the U.S., exceeding the expectations of approximately 100,000.

  • The companies continue to conduct in vitro testing of sotrovimab against new variants and subvariants as they emerge and plan to submit data in 2H of 2022.

  • Sotrovimab is being evaluated PROTECT-V Phase 3 prophylaxis trial sponsored by Cambridge University Hospitals National Health Service Foundation Trust. Initial data are expected in 2023.

  • It is being evaluated at a 1g dose among patients hospitalized with COVID-19 in the U.K. The timing of initial data will depend on the continued rate of enrollment.

  • The company has over $2.6 billion in cash, cash equivalents, investments, and profit-share payments to be received from GSK, expected to fund the company's ongoing operations and liabilities for up to five years.

  • Price Action: VIR shares traded 10.60% lower at $25.79 during premarket trading on the last check Wednesday.

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