- The shares of commercial-stage biotech Eiger BioPharmaceuticals, Inc. ( NASDAQ: EIGR ) fell ~21% in the pre-market Tuesday after the company announced that the FDA is uncertain about the regulatory path for COVID-19 therapy peginterferon lambda.
- The update comes after the company's meeting with the regulator regarding the Phase 3 TOGETHER study for peginterferon lambda aimed at its emergency use authorization (EUA).
- Following the meeting, the FDA has indicated its uncertainty if the company can meet the requirements for a EUA submission for peginterferon lambda.
- However, EIGR remains in talks with the FDA as the regulator indicated its intention to consider any new data from the TOGETHER trial to support a EUA while the company plans to further develop the candidate in COVID-19.
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Eiger falls 21% amid uncertainty over regulatory path for COVID-19 therapy