- Eiger BioPharmaceuticals, Inc. ( NASDAQ: EIGR ), a biotech focused on rare and ultra-rare diseases, slipped ~20% pre-market Wednesday after announcing it would not seek an emergency use authorization (EUA) application in the U.S. for COVID-19 therapy peginterferon lambda.
- The decision followed a pre-EUA meeting the company had requested from the FDA. The agency denied the request citing issues in an investigator-sponsored trial designed to assess different therapeutic agents, including peginterferon, in non-hospitalized patients with mild-to-moderate COVID-19.
- FDA has determined that “any authorization request based on these data is unlikely to meet the statutory criteria for issuance of an EUA in the current context of the pandemic,” the company said.
- Instead, the agency has suggested that EIGR consider requesting an end-of-Phase 2 meeting to run a company-sponsored pivotal trial targeted at a Biologics License Application (BLA).
- EIGR is weighing the next steps, including strategic options to advance peginterferon lambda for respiratory viral agents, including COVID-19.
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Eiger sheds ~20% on abandonment of EUA request for COVID therapy