Eiger BioPharmaceuticals, Inc (NASDAQ:EIGR)

Eiger BioPharmaceuticals, Inc. (NASDAQ:EIGR), a commercial-stage biotech business, reported on Tuesday that the FDA is unsure about the regulatory path for the COVID-19 therapeutic peginterferon lambda. As a result, the stock sank by 21% in pre-market trading.

The announcement follows a discussion between the firm and the regulatory body addressing the Phase 3 TOGETHER trial for peginterferon lambda, which is intended to support its emergency use authorization (EUA). Following the discussion, the FDA expressed doubt about the company’s ability to fulfill the conditions for an EUA filing for peginterferon lambda.

But even if the company intends to advance the candidate in COVID-19, EIGR is still in discussions with the FDA about its intentions to evaluate any new data from the TOGETHER trial to support an EUA. Read more about the TOGETHER study’s data, which showed, among other things, that a single subcutaneous Lambda injection reduced the probability of hospitalizations and ER visits lasting longer than six hours by 50%.

The FDA and the Phase 3 TOGETHER trial of peginterferon lambda for COVID-19 cooperated and exchanged a great deal of pre-EUA material. However, the FDA has stated that it is not yet able to establish if the requirements for submitting an application and receiving a EUA are likely to be met.

FDA has stated that it will take into account any fresh data and information from the TOGETHER study to support an EUA as well as the company’s future intentions for peginterferon lambda for COVID-19 research. Eiger is still in contact with the FDA and will continue to do so while also giving the organization any new information it thinks could help with an EUA.

Peginterferon Lambda Information

Peginterferon lambda is the investigational late-stage, first-in-class type III interferon (IFN) that activates immunological responses that are essential for the development of host protection during viral infections and has been well-tolerated in human investigations.

Peginterferon lambda is to be given as a single subcutaneous injection, allowing it to be prescribed and given at the first indication of infection or at the first awareness of exposure, potentially assisting patients in avoiding serious sickness that can result in hospitalization and death.

About the TOGETHER Study

TOGETHER is A multi-center, randomized, placebo-controlled, adaptive platform Phase 3 research that assesses therapeutics in COVID-19 patients who have just received a high-risk, non-hospitalized diagnosis. 11 different treatment drugs have been tested in TOGETHER, the biggest placebo-controlled study of COVID-19 patients who are not hospitalized. As the second largest study of a COVID-19 drug to date compared peginterferon lambda against a placebo.

On Eiger

Eiger is a biopharmaceutical company in the commercial stage that specializes in the creation of ground-breaking treatments for critical diseases such as hepatitis delta virus (HDV). Two first-in-class medicines that target crucial host processes involved in viral replication are part of the Eiger HDV platform and are currently in Phase 3. All five Eiger rare disease programs—lonafarnib and peginterferon lambda for HDV, Zokinvy for progeria, and avexitide for both congenital hyperinsulinism and post-bariatric hypoglycemia—have received FDA Breakthrough Therapy designation.

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