 Immunic IMUX has announced positive top-line data from its phase 2 EMPhASIS trial of lead asset, IMU-838, the companys selective oral DHODH inhibitor, in patients with relapsing-remitting multiple sclerosis RRMS. Shares are now spiking 35 in Mondays pre-market trading.The study achieved all primary and key secondary endpoints, indicating activity in RRMS patients.In particular, the study met its primary endpoint, demonstrating a statistically significant reduction in the cumulative number of combined unique active CUA magnetic resonance imaging MRI lesions up to week 24 in patients receiving 45mg of IMU-838 once daily, by 62 p0.0002, as compared to placebo.The study also met its key secondary endpoint, showing a statistically significant reduction in the cumulative number of CUA MRI lesions for the 30mg once daily dose, by 70 p0.0001, as compared to placebo.All other secondary endpoints, including those based on other MRI parameters and on clinical endpoints such as relapse events, also provided a noticeable signal and numerical benefit for the IMU-838 treatment groups, as compared to placebo.Moreover, administration of IMU-838 was observed to be safe and well-tolerated with a 42.9 rate of treatment-emergent adverse events vs 43.5 for placebo. Likewise, serious treatment-emergent adverse events were only observed in 3 out of 140 IMU-838-treated patients, and in 1 out of 69 patients on placebo.The phase 2 EMPhASIS trial was an international, multicenter, double-blind, placebo-controlled, randomized, parallel-group study, designed to assess the efficacy and safety of IMU-838 in patients with RRMS. Of the 210 patients randomized in 36 centers, 209 patients received at least one dose of IMU-838 or placebo, and 197 patients completed the blinded 24-week treatment period.Given the strength of these top-line results, we will continue to prepare a clinical phase 3 program for IMU-838 in RRMS and, after a full review of the data, anticipate providing a further update on development strategy commented Daniel Vitt, CEO of Immunic.We are also looking forward to reading out clinical data from the other ongoing phase 2 trials of IMU-838 in COVID-19, primary sclerosing cholangitis and ulcerative colitis in the upcoming months he added.Meanwhile the company announced a net loss for the three months ended June 30, 2020 of 11.5 million, or 0.90 per basic and diluted share.Shares in Immunic have exploded by 77 year-to-date, and analysts have a unanimously bullish outlook on the stock. The Strong Buy Street consensus comes with a 48 average analyst price target, indicating significant further upside potential lies ahead.According to HC Wainwright analyst Ram Selvaraju the positive top-line data of IMU-838 in RRMS could facilitate a transformative out-licensing deal. For the analyst the next key upcoming catalyst is potential interim clinical data from the CALVID-1 trial, proving the impact of IMU-838 in attenuating viral load in COVID-19-infected patients. See IMUX stock analysis on TipRanks.Related News: GW Pharma Scores New FDA Approval For CBD Drug Epidiolex Incyte, MorphoSys Win FDA Nod For Key Revenue Driver Tafasitamab Moderna Could Charge 50-60 Per Covid-19 Vaccine Course- Report More recent articles from Smarter Analyst: Eli Lilly Kicks Off Covid-19 Antibody Trial In Nursing Home Residents Nordex To Sell Wind, Solar Projects To RWE For 474 Million Nio July Car Deliveries Spike 322; Shares Up 6 In Pre-Market Varian Pops 24 In Pre-Market On 16.4B Buyout Deal; BTIG Sticks To Buy 