On Monday, H.C. Wainwright maintained its Buy rating and $8.00 price target for InflaRx NV (NASDAQ:IFRX), currently trading at $2.24, following the company's announcement on December 20 about the commencement of a Phase 2a basket study for its drug candidate INF904.
According to InvestingPro data, analysts maintain a strong bullish consensus with price targets ranging from $4.95 to $12.65, suggesting significant upside potential. InflaRx NV reported the first patient dosing in the study, which is evaluating the drug for the treatment of chronic spontaneous urticaria (CSU) and hidradenitis suppurativa (HS).
INF904, an orally available C5a receptor antagonist, is being tested for its potential as a best-in-class treatment option. The study is set to explore at least three different doses of INF904 over a four-week period. While the company's financial health score from InvestingPro is rated as 'Fair', investors should note the company holds more cash than debt on its balance sheet, with a healthy current ratio of 5.31x.
In addition to safety and pharmacokinetics (PK), the study aims to observe preliminary signs of efficacy through weekly patient visits. The research will include exploratory clinical endpoints and patient-reported outcomes tailored to each disease.
For the CSU portion of the study, 45 patients are expected to be dosed with a 1:1:1 randomization across two different doses of INF904, either 60mg or 120mg taken twice daily (BID). A third arm of the study will include 120mg BID for patients who do not respond to anti-IgE treatment. The CSU group will be evaluated using various efficacy measures such as the Urticaria Activity Score 7 (UAS7), Hives Severity Score (HSS7), and Itch Severity Score, comparing baseline scores to those at the end of week four.
The company plans to conduct responder analyses, biomarker assessments, and evaluate Patient-Reported Outcome (PRO) endpoints that focus on urticaria control and quality of life. A meaningful efficacy outcome for CSU patients is anticipated to be a change from baseline of approximately 10 or 9 in UAS7. H.C. Wainwright forecasts the launch of INF904 in 2030, with sales projected at $86 million in its first year, increasing to $225 million by 2031.
The firm reiterates its Buy rating and $8 price target for InflaRx NV. The stock has shown strong momentum with a 45.45% return over the past six months, though InvestingPro analysis indicates the company is currently trading near its Fair Value. Subscribers can access 11 additional ProTips and detailed financial metrics to better evaluate the investment opportunity.
In other recent news, InflaRx has been the focus of several key developments. Lucid (NASDAQ:LCID) Capital Markets initiated coverage on InflaRx NV with a Buy rating, highlighting the potential of vilobelimab and INF904, both under evaluation for treating various inflammatory diseases. The European Medicines Agency's Committee for Medicinal Products for Human Use has also given a positive opinion for InflaRx's drug GOHIBIC, which demonstrated a 23.9% relative reduction in 28-day all-cause mortality in a Phase 3 trial involving COVID-19 patients in intensive care units.
InflaRx reported promising results from a Phase 2b study of vilobelimab in treating hidradenitis suppurativa. Additionally, the company presented preclinical data on its novel oral C5aR inhibitor, INF904, at the European Meeting on Complement in Human Diseases. Analysts from H.C. Wainwright have maintained a Buy rating for InflaRx following the presentation of a post hoc analysis of the Phase 2b SHINE trial, which showed significant clinical efficacy endpoints.
Vilobelimab, InflaRx's investigational drug, has been selected by the Biomedical Advanced Research and Development Authority for a Phase 2 clinical study aimed at exploring new treatments for acute respiratory distress syndrome.
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