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Immunic Gets FDA Allowance for Phase II Coronavirus Study

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Immunic, Inc. IMUX announced that it has received allowance from the FDA to initiate a phase II study on its oral DHODH inhibitor IMU-838 for treating coronavirus disease (COVID-19).

The CALVID-1 study will evaluate the safety, efficacy and tolerability of IMU-838 in patients with moderate COVID-19 at centers across the United States. Top-line data from the same is expected later in 2020.

Per the press release, CALVID-1 is a prospective, randomized, placebo-controlled, double-blind study, which received regulatory allowance from the German health authority in May. Subsequently, it also received regulatory allowances from other European countries involved in the above-mentioned study.

Shares of Immunic have rallied 32% so far this year compared with the industry’s increase of 7.9%.


Notably, IMU-838 is a next-generation, oral selective immune modulator that inhibits the intracellular metabolism of activated immune cells by blocking the enzyme DHODH.

In April 2020, Immunic announced that IMU-838 successfully demonstrated preclinical activity against SARS-CoV-2, the virus that causes the deadly COVID-19.

This apart, IMU-838 is being evaluated in other phase II studies for treating relapsing-remitting multiple sclerosis and ulcerative colitis. An additional phase II study on IMU-838 is being considered for Crohn’s disease.

Meanwhile, Immunic’s collaboration partner, the Mayo Clinic, is also evaluating IMU-838 in an investigator-sponsored proof-of-concept clinical study for patients with primary sclerosing cholangitis.

Zacks Rank & Other Stocks to Consider

Immunic currently carries a Zacks Rank #2 (Buy). Other top-ranked stocks in the biotech sector include NuCana PLC NCNA, Ligand Pharmaceuticals Inc. LGND and Akcea Therapeutics, Inc. AKCA, all sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

NuCana’s loss per share estimates have narrowed 17% for 2020 and 18.1% for 2020 over the past 60 days.

Ligand’s earnings estimates have been revised 7.2% upward for 2020 and 10% for 2021 over the past 60 days. The stock has increased 18.6% year to date.

Akcea Therapeutics’ loss per share estimates have narrowed 33.8% for 2020 and 24.8% for 2020 over the past 60 days.

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Click to get this free report Ligand Pharmaceuticals Incorporated (LGND) : Free Stock Analysis Report Akcea Therapeutics, Inc. (AKCA) : Free Stock Analysis Report NuCana PLC Sponsored ADR (NCNA) : Free Stock Analysis Report Immunic, Inc. (IMUX) : Free Stock Analysis Report To read this article on Zacks.com click here. Zacks Investment Research