|Over a week ago|
Fly Intel: Pre-market Movers » 09:0205/1405/14/20
INO, ALLO, IMUX, WIX, ETRN, EQM, XCUR, NCLH, SSYS, CSCO, SDC, I, MGNX
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Fly Intel: After-Hours Movers » 19:0405/1305/13/20
KNSA, ARVN, SDC, JACK, VRTU, ONEM, PANL, FCAU, MA, IMGN, ALLO, IMUX, OII, FLO, CSCO, RVLV, BRP, JAKK, RKDA
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Immunic up 45% afterhours following ph.2 trial of IMU-838 approval in Germany 16:3005/1305/13/20
Immunic's Phase 2 trial in COVID-19 approved in Germany » 16:0605/1305/13/20
Immunic has received…
Immunic has received first regulatory approval from Germany's BfArM - Bundesinstitut fur Arzneimittel und Medizinprodukte - to initiate a phase 2 clinical trial of its selective oral DHODH inhibitor, IMU-838, in coronavirus disease 2019. The CALVID-1 study is a prospective, phase 2 clinical trial in approximately 230 patients with moderate COVID-19, designed to evaluate efficacy, safety and tolerability of IMU-838. Dosing of the first patient is expected to occur later this month. Top-line data is expected to be available later this year. IMU-838 had successfully demonstrated preclinical activity against severe acute respiratory syndrome coronavirus 2 - SARS-CoV-2 -. Specifically, IMU-838 was observed to inhibit replication of clinical isolates of SARS-CoV-2 associated with COVID-19. IMU-838 has already been tested in about 650 individuals. The aim of the CALVID-1 trial is to investigate IMU-838 as an oral treatment option for COVID-19 and to enable the use of IMU-838 as a treatment for current and potential future pandemic threats. Inclusion criteria are hospitalized adult patients with a confirmed SARS-CoV-2 infection fulfilling clinical status category 3 or 4. The primary endpoint will be the proportion of patients free of invasive ventilation throughout the entire study period. Secondary endpoints include duration of hospitalization, duration of intensive care unit treatment, 28-day all-cause mortality, time to clinical improvement and viral titer reduction. If clinical activity of IMU-838 is confirmed by the Independent Data Monitoring Committee, an expansion of this trial into a confirmatory phase 3 trial could be recommended.
Fly Intel: Top five analyst initiations » 10:1005/1105/11/20
EIX, BAND, IMUX, FRPT, ABBV
Catch up on today's…
Catch up on today's top five analyst initiations with this list compiled by The Fly: 1. Edison International (EIX) initiated with an Overweight at KeyBanc. 2. Bandwidth (BAND) initiated with an Outperform at William Blair. 3. Immunic (IMUX) initiated with a Buy, $45 price target at H.C. Wainwright. 4. Freshpet (FRPT) initiated with a Neutral at Citi. 5. AbbVie (ABBV) resumed with an Overweight at Morgan Stanley. This list is just a portion of The Fly's analyst coverage. To see The Fly's full Street Research coverage, click here.
Immunic initiated with a Buy, $45 price target at H.C. Wainwright » 07:2505/1105/11/20
H.C. Wainwright analyst…
H.C. Wainwright analyst Raghuram Selvaraju initiated coverage of Immunic with a Buy rating and $45 price target. Immunic is an emerging biotech company with a lead asset, IMU-838, in Phase 2 testing across three autoimmune indications: relapsing-remitting multiple sclerosis, inflammatory bowel disease and primary sclerosing cholangitis, Selvaraju tells investors in a research note. The analyst views IMU-838 as a "substantially de-risked asset," noting it is based on a predecessor molecule, vidofludimus, which previously went through extensive clinical testing and was dosed in over 300 human subjects. Superior safety and tolerability of IMU-838 should permit it to gain traction in other autoimmune and inflammatory conditions as well, contends Selvaraju, who sees "substantial near-term value-driving catalysts."
Immunic down 2.5% after reporting Q1 results 06:4605/0805/08/20
Immunic reports Q1 EPS (79c), consensus (95c) » 06:4505/0805/08/20
"The global coronavirus disease 2019 (COVID-19) pandemic has led to a period of intense, additional focus for Immunic, as we quickly recognized the potential of our lead asset, selective oral DHODH inhibitor, IMU-838, as a possible therapeutic for the treatment of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections, given its already well-recognized, broad-spectrum antiviral effects," stated Daniel Vitt, Ph.D., CEO and President of Immunic. "After performing preclinical testing, we recently announced that, in cellular assays, IMU-838 successfully demonstrated antiviral activity against SARS-CoV-2 at blood concentrations which are well below those associated with IMU-838 dosing regimens studied in our ongoing and previous clinical trials. Based on these positive results, we are preparing a phase 2 clinical development program for IMU-838 as a potential treatment for this devastating disease." Dr. Vitt continued, "On the heels of this encouraging preclinical data, we were able to bolster our financial position with a successful $15.0 million financing. As a result, we expect to be well funded through key, near-term milestones including top-line data from both our phase 2 trial of IMU-838 for relapsing-remitting multiple sclerosis, or RRMS, expected in the third quarter of this year, as well as results from the investigator-sponsored phase 2 trial for IMU-838 in primary sclerosing cholangitis, or PSC, expected in early 2021."
|Over a month ago|
Fly Intel: Pre-market Movers » 08:5804/2204/22/20
IMUX, MNK, EXPE, T, DAL, KMB, DGX, TER, CMG, BIIB, NFLX, IBKR, IRBT
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Immunic reports IMU-838 demonstrates activity against SARS-CoV-2 » 07:5704/2204/22/20
Last night, Immunic…
Last night, Immunic reported that its lead asset, IMU-838, a selective oral DHODH inhibitor, has demonstrated preclinical activity against severe acute respiratory syndrome coronavirus 2, or SARS-CoV-2. More specifically, IMU-838 was observed to inhibit replication of clinical isolates of SARS-CoV-2 associated with COVID-19. In cellular assays, IMU-838 demonstrated this antiviral activity at concentrations which are well below the blood concentrations associated with IMU-838 dosing regimens studied in ongoing and previous clinical trials. These results have encouraged Immunic to prepare a clinical development program for IMU-838 as a potential treatment option for patients with COVID-19 and potential other, future viral pandemics. IMU-838 is already being investigated in ongoing phase 2 clinical trials in patients with relapsing-remitting multiple sclerosis, ulcerative colitis and primary sclerosing cholangitis. Although the drug is being studied in these ongoing trials primarily for its anti-inflammatory effect, one of IMU-838's postulated benefits is a host-based antiviral effect, which may be important in these indications to potentially prevent virus reactivations known to occur with other immunomodulatory therapies. In support, IMU-838's antiviral activity has previously been demonstrated in vitro against human immunodeficiency virus, or HIV, hepatitis C virus, or HCV, human cytomegalovirus, or hCMV, Arenavirus and Influenza A virus. Given what is known about the natural course of the disease, IMU-838's combination of antiviral activity against the highly pathogenic SARS-CoV-2 and a selective immunomodulatory effect against highly activated immune cells may be a promising profile for the treatment of COVID-19. The company said IMU-838 has an attractive pharmacokinetic, safety and tolerability profile and, to date, has already been tested in about 650 individuals. Management noted that Immunic is collaborating with several regulatory agencies and other institutions in the United States and in Europe to define and accelerate the development path for IMU-838 in COVID-19. The aim is to investigate IMU-838 as an oral treatment option for COVID-19 and to enable the use of IMU-838 in treating current and potential future pandemic threats. Immunic intends to initiate a prospective, multicenter, randomized, placebo-controlled, double-blind phase 2 clinical trial in patients with moderate COVID-19 disease and clinical symptoms, in order to evaluate efficacy, safety and tolerability. The plan is to test IMU-838 versus placebo on the background of investigator's choice of standard-of-care therapy used in both treatment arms. Adequate drug supply exists to begin clinical testing in COVID-19 very soon.