On Monday, H.C. Wainwright began coverage of Immunic Inc. (NASDAQ: NASDAQ:IMUX) stock by assigning a Buy rating and setting a price target of $10.00 per share. The firm's optimism is based on Immunic's comprehensive approach to treating both relapsing and progressive multiple sclerosis (MS) with its drug, vidofludimus calcium.
The positive interim analysis from the Phase 3 ENSURE trial in relapsing MS (RMS) is highlighted as a significant de-risking factor, as the trial passed its futility test and maintained its sample sizes without modification. This interim data supports the potential of vidofludimus calcium as a novel neuroprotective and anti-inflammatory therapy.
Looking ahead, a key catalyst for Immunic is the expected results from the Phase 2 CALLIPER trial in progressive MS (PMS), anticipated in April 2025. This trial focuses on the annualized rate of percent brain volume change, a primary endpoint that could demonstrate the drug's neuroprotective effects and its impact on disease progression independent of relapse activity.
The analyst points out the dual mode of action of vidofludimus calcium, which includes neuroprotection through Nurr1 activation and relapse prevention via DHODH inhibition. This combination could represent a significant advancement in MS treatment, which has traditionally focused on relapse prevention through broad immunosuppression.
Supporting the drug's potential, the completed interim biomarker analysis from the Phase 2 CALLIPER trial in PMS patients showed a reduction in neurofilament light chain (NfL), a biomarker for neuronal damage. Additionally, the analyst notes that the gastrointestinal benefits observed in clinical trials may indicate further upside for Immunic's pipeline beyond MS treatment. With these factors in mind, H.C. Wainwright has initiated coverage with a positive outlook on Immunic's stock.
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