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- Biophytis SA (NASDAQ:BPTS) has announced that patient recruitment in the U.S., paused in May while waiting for results of the Interim Analysis 2, has restarted.
- The Data Monitoring Committee (DMC) had recommended in September from the Interim Analysis 2 the continuation of the COVA study unmodified with Sarconeos (BIO101) for COVID-19.
- The COVA study has enrolled 216 patients hospitalized with severe pneumonia from COVID-19 infection in 35 U.S., Brazil, France, and Belgium centers.
- In addition, five new clinical centers are expected to rapidly start recruiting patients in Brazil and the U.S., over a total target of 15 additional clinical centers.
- The end of recruitment and final results of the COVA study is expected during Q1 of 2022.
- FDA Emergency Use Authorization in the U.S. and Conditional Marketing Authorization in Europe for Sarconeos (BIO101) for COVID-19 could be obtained as early as in Q2 of 2022.
- Price Action: BPTS shares are up 9.12% at $6.10 during the market session on the last check Monday.
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