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Immunic Gets FDA Allowance for Phase II Coronavirus Study
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Immunic, Inc. (IMUX - Free Report) 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 - Free Report) , Ligand Pharmaceuticals Inc. (LGND - Free Report) and Akcea Therapeutics, Inc. , 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.
Breakout Biotech Stocks with Triple-Digit Profit Potential
The biotech sector is projected to surge beyond $775 billion by 2024 as scientists develop treatments for thousands of diseases. They’re also finding ways to edit the human genome to literally erase our vulnerability to these diseases.
Zacks has just released Century of Biology: 7 Biotech Stocks to Buy Right Now to help investors profit from 7 stocks poised for outperformance. Our recent biotech recommendations have produced gains of +50%, +83% and +164% in as little as 2 months. The stocks in this report could perform even better.
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Immunic Gets FDA Allowance for Phase II Coronavirus Study
Immunic, Inc. (IMUX - Free Report) 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 - Free Report) , Ligand Pharmaceuticals Inc. (LGND - Free Report) and Akcea Therapeutics, Inc. , 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.
Breakout Biotech Stocks with Triple-Digit Profit Potential
The biotech sector is projected to surge beyond $775 billion by 2024 as scientists develop treatments for thousands of diseases. They’re also finding ways to edit the human genome to literally erase our vulnerability to these diseases.
Zacks has just released Century of Biology: 7 Biotech Stocks to Buy Right Now to help investors profit from 7 stocks poised for outperformance. Our recent biotech recommendations have produced gains of +50%, +83% and +164% in as little as 2 months. The stocks in this report could perform even better.
See these 7 breakthrough stocks now>>