Leerink Partners analyst Faisal Khurshid said that he likes the “risk/reward” profile of Immunic’s CALLIPER trial readout, expected in April 2025. Immunic hosted a Multiple Sclerosis (MS) R&D Day on September 10, discussing the MS landscape and the potential benefits of its lead drug candidate, Vidofludimus Calcium (IMU-838), compared to peers.
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Following the conference, the analyst reiterated a Buy rating on IMUX stock with a price target of $5, which implies an attractive 229% upside potential from current levels. Khurshid is a five-star analyst on TipRanks, boasting an impressive average return per rating of 97.9% and a success rate of 78%. IMUX stock gained 2% in regular trading on September 13, following his rating.
Khurshid’s Key Takeaways from Immunic’s R&D Day
Khurshid continues to have a constructive view on the Phase 2 CALLIPER trial readout on Progressive MS. Here are his key takeaways.
- Management Reinforced Importance of IMU-838 – During the presentation, management discussed the significance of Vidofludimus Calcium’s combined power of neuroprotective, anti-inflammatory, and anti-viral properties, promising to address multiple drivers of neurodegeneration in patients suffering from MS. The management also reinforced the drug’s trial data, which supported its clinical relevance for both Progressive MS and Relapsing MS.
- Analysing Brain Volume vs. Disability Worsening Endpoints – Khurshid cited IMU-838’s two important endpoints, including brain volume data and disability worsening. Interestingly, Khurshid believes that disability worsening takes precedence over brain volume data as it will hold more relevance in the Phase 3 studies. The data readout for the CALLIPER Phase 2 trial conducted on 467 patients is due in April 2025, and brain volume is the primary endpoint for this trial.
- Futility Analysis for Phase 3 ENSURE Trial in RMS – Immunic is currently conducting the Twin Phase 3 ENSURE trials to study the efficacy, safety, and tolerability of Vidofludimus Calcium against placebo in RMS patients. The analyst expects futility analysis and sample size re-estimation results set for late 2024 to be a “non-event,” since these are placebo-controlled and blinded trials. This ultimately means that the event will have no impact on IMUX stock.
- Commercial Prospects of MS Drugs – Immunic’s newly instated President and COO Jason Tardio, who has significant experience in the commercialization of MS-related drugs, gave an impressive overview of Vidofludimus Calcium’s commercial opportunity and positioning in both PMS and RMS. Tardio particularly emphasized the drug’s best-in-class risk/benefit profile, once-daily dosage, and solid efficacy results so far as compared to other oral options. The company stressed the importance of the drug’s effect on relapse-independent progression (PIRA), a benefit that none of the approved therapies offer.
- Relevance of Biomarkers – Immunic also hosted Dr. Amit Bar-Or, a renowned MS KOL, who highlighted the highly unmet need in PMS related to the underlying progressive biology. IMU-838 has shown a positive correlation between serum NfL (neurofilament light chain) and disability outcomes. Also, he referred to the GFAP (glial fibrillary acidic protein) biomarker for predicting future disability risk in MS patients. Both these biomarkers are important studies in Immunic’s CALLIPER trial readout expected in April 2025.
Overall, Khurshid came away with positive insights into the potential commercialization of Immunic’s Vidofludimus Calcium in the treatment of PMS and RMS. He is most focused on the Phase 2 CALLIPER trial readout in April 2025, since the drug has shown significant promise in trials so far.
Is Immunic Stock a Buy?
Analysts seem to be getting more confident about Immunic’s drug pipeline, with positive readouts reported from the trials to date. With three unanimous Buy ratings, IMUX stock has a Strong Buy consensus rating on TipRanks. Also, the average Immunic price target of $13 implies 772.5% upside potential from current levels. Meanwhile, IMUX shares have gained 12% in the last six months.
This article was written in partnership with Immunic. TipRanks may be compensated for its publication.
