RedHill (RDHL) Down on Unsatisfactory Data From COVID-19 Study

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Shares of RedHill Biopharma Ltd. RDHL were down 32.7% on Tuesday after the company announced preliminary top-line data from the phase II/III study evaluating its COVID-19 drug, opaganib, in hospitalized patients with severe COVID-19 pneumonia. The study did not meet its primary endpoint.

The stock has plunged 38.5% so far this year compared with the industry’s decrease of 11.1%.

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An analysis of the efficacy endpoints in the above-mentioned study showed favorable trends in the opaganib arm versus placebo across multiple endpoints, including the primary endpoint. However, the study endpoints did not achieve statistical significance. The data demonstrated a good tolerability profile of opaganib.

RedHill is analyzing the data in a subset of patients requiring less oxygen to see if opaganib has the potential to show increased benefit at earlier stages of the disease.

We remind investors that, in January 2021, the company announced preliminary top-line data from a phase II study in the United States on opaganib as a potential treatment for patients hospitalized with COVID-19 pneumonia. The data showed that opaganib was safe, and demonstrated greater improvement in reducing oxygen requirement by the end of treatment at day 14.

We note that opaganib, an oral pill drug candidate with dual anti-inflammatory and antiviral activity, is currently being evaluated in a phase II/III study in hospitalized patients with COVID-19.

Earlier this month, the company announced encouraging preclinical data from an in vitro study evaluating opaganib in kidney inflammation and fibrosis. Data from the same showed that opaganib achieved efficacy in significantly reducing renal fibrosis in patients with chronic kidney disease in a well-characterized unilateral ureteral obstruction model.

Apart from opaganib, RedHill is also evaluating another orally-administered drug candidate, RHB-107, in a phase II/III study, for treating non-hospitalized symptomatic COVID-19 patients. The candidate is being developed as a potential treatment in the early course of COVID-19.

Zacks Rank & Stocks to Consider

RedHill currently carries a Zacks Rank #4 (Sell).

Some better-ranked stocks in the biotech sector include Spero Therapeutics, Inc. SPRO, vTv Therapeutics Inc. VTVT and Corvus Pharmaceuticals, Inc. CRVS, all carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Spero Therapeutics’ loss per share estimates have narrowed 8.2% for 2021 and 10.6% for 2022 over the past 60 days.

vTv Therapeutics’ loss per share estimates have narrowed 23.3% for 2021 and 2.8% for 2022 over the past 60 days.

Corvus Pharmaceuticals’ loss per share estimates have narrowed 24.4% for 2021 and 21.4% for 2022 over the past 60 days.


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