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Tuesday, September 21, 2021

RedHill Biopharma Ltd. (RDHL) Stock Plummets After Failure of Opaganib Trial To Meet Primary Endpoints

RedHill Biopharma Ltd. (RDHL) stock prices plummeted by 32.25% shortly after market trading commenced on September 14th, 2021. This brought the price per share down to USD$5.00 early on in the trading day.

RDHL Stock’s Opaganib Study

September 14th 2021 saw RDHL stock announce preliminary topline data from its study of opaganib. The global Phase 2/3 study enrolled 475 patients the were hospitalized with severe Covid-19 pneumonia. The data showed that the study did not meet its primary endpoint. The analysis of the study efficacy endpoints showed trends in favor of the treatment arm as compared to the placebo. This is across several endpoints, including the primary endpoint, despite not having achieved statistical significance.


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Results of the Study

Topline safety data showed good tolerability of opaganib, exhibiting balanced adverse events observed between the various study arms. The findings, in conjunction with preliminary analysis could support the potential utilization of opaganib in earlier stages of the disease. The preliminary analysis pointed to an increased benefit in a subset of patients that required less oxygen. The results were in line with the previously announce results from the U.S. Phase 2 study, as well as the previously observed antiviral activity of opaganib.

Details of RDHL Stock’s Study

The trial was a multi-center, randomized, double-blind, parallel-arm, placebo-controlled Phase 2/3 study. Subjects were randomized at a 1:1 ration to receive either opaganib or placebo in addition to the standard of care therapy. The primary endpoint of the study was the proportion of patients that were able to breathe room air without oxygen support by the end of the second week of treatment.

Scope of Opaganib

RDHL stock’s proprietary opaganib treatment is a novel small molecule investigational drug in oral pill form. The treatment has a unique dual antiviral and anti-inflammatory mechanism of action. This mechanism acts on the viral cause and inflammatory effect of Covid-19. This is facilitated by the exerting of its antiviral effect by selectively inhibiting SK2, a key enzyme produced in human cells that has been known to be recruited by the virus to support its replication.

Future Outlook for RDHL Stock

With the world hurtling towards universal immunizations, the company is poised to recover from its recent devastating blow. RDHL stock is keen to address its recent failures to capitalize on the burgeoning marketspace. Current and potential investors are hopeful that management will be able to leverage the resources at their disposal. This is hoped to facilitate significant and sustained increases in shareholder value.

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