US stock futures flounder amid tech weakness, Fed caution
NEW YORK - Immunic, Inc. (NASDAQ: IMUX), a biotech firm specializing in treatments for chronic inflammatory and autoimmune diseases with a market capitalization of $123 million, unveiled positive phase 2 trial results for its drug candidate vidofludimus calcium in progressive multiple sclerosis (PMS) patients. The company, whose stock has surged over 28% year-to-date according to InvestingPro data, announced these findings today, alongside a webcast to discuss the data.
The CALLIPER trial involved 467 PMS patients, revealing a 20% reduction in the risk of disability worsening over 24 weeks compared to a placebo. Notably, patients with primary progressive multiple sclerosis (PPMS) exhibited a 30% risk reduction, while those with non-active secondary progressive multiple sclerosis (naSPMS) showed a 15% decrease. InvestingPro analysis shows the company maintains a strong balance sheet with more cash than debt, though it’s currently burning through cash reserves as it advances its clinical programs.
Vidofludimus calcium also demonstrated a 29% risk reduction in patients without inflammatory lesions at baseline, indicating its potential neuroprotective effects through Nurr1 activation. Moreover, the drug reduced the annualized rate of thalamic brain volume loss by 20%, a significant marker associated with clinical disability progression in PMS.
Safety and tolerability profiles from previous trials were confirmed, with no new safety signals detected. The occurrence of adverse events was comparable between the vidofludimus calcium group and the placebo group.
Immunic’s CEO, Daniel Vitt, Ph.D., expressed optimism about the drug’s efficacy, particularly in the PPMS population, and indicated plans to discuss next steps with healthcare authorities. Chief Medical Officer Andreas Muehler, M.D., M.B.A., highlighted the drug’s unique mode of action and its potential as a neuroprotective treatment for MS.
The CALLIPER trial was a double-blind, placebo-controlled study conducted across North America and Europe. The full data set is still under analysis and will be presented at upcoming scientific meetings. Immunic is also conducting ongoing phase 3 trials for vidofludimus calcium in relapsing multiple sclerosis, expected to be completed in 2026.
The company emphasizes the need for effective therapies for MS, particularly for PPMS and naSPMS, where treatment options are limited. This press release statement outlines the potential of vidofludimus calcium as a novel treatment for PMS, based on the encouraging results from the phase 2 CALLIPER trial. With analyst price targets ranging from $5 to $28 and an overall Financial Health score of "Fair" from InvestingPro, investors can access comprehensive analysis and 8 additional ProTips about IMUX through the platform’s detailed research reports.
In other recent news, Immunic, Inc. has announced a registered direct offering of its common stock, aiming to raise approximately $5.1 million. This offering, led by Aberdeen Investments, involves the sale of 5,666,667 shares at $0.90 each and is expected to close soon, subject to customary conditions. The funds are intended to support clinical trials and general corporate purposes. Additionally, William Blair has initiated coverage on Immunic with an Outperform rating, citing the potential of its RMS therapy, vidofludimus calcium, and its promising safety profile. This is further complemented by H.C. Wainwright maintaining a Buy rating and a $10 price target, emphasizing the potential impact of Immunic’s IMU-856 on GLP-1 levels, which could be significant for obesity management. The Phase 1b findings of IMU-856 have shown a dose-dependent increase in GLP-1 levels and a reduction in body weight gain in preclinical studies. Immunic is preparing for further clinical testing of IMU-856, which remains investigational and unapproved by regulatory authorities. These developments highlight Immunic’s ongoing efforts in advancing its treatment pipeline for chronic inflammatory and autoimmune diseases.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.