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RedHill (RDHL) COVID Pneumonia Drug Meets Study Goal, Stock Up

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RedHill Biopharma’s (RDHL - Free Report) shares were up 11.7% on Monday, after the company announced positive new data from the phase II/III study evaluating its oral COVID-19 drug, opaganib, in hospitalized patients with severe COVID-19 pneumonia.

Data from the study demonstrated that oral opaganib led to a statistically significant reduction in mortality by 62% compared to treatment with placebo. The study also met its primary endpoint of reaching room air at a 21% efficacy benefit when treated with opaganib over placebo. Patients treated with opaganib showed a median time of 10 days to hospital discharge compared with 14 days for the placebo arm, thereby saving four days.

It is to be noted that Opaganib is being developed as an oral pill candidate with dual anti-inflammatory and antiviral activity.

Shares of RedHill have plunged 39.6% so far this year against the industry’s 15.5% decline.

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The new data follows the company’s previously announced preliminary top-line data from the same study.

Per the press release, the company continues to analyze the top-line data for opaganib in the given indication, including an analysis of the potential treatment for the disease in its early stage. The company also plans to discuss the results of the study with the FDA and other health regulators for taking the necessary next steps.

Apart from COVID-19, opaganib has demonstrated anti-cancer activity and is being evaluated across multiple cancer indications. The drug has received the Orphan Drug designation from the FDA for the treatment of cholangiocarcinoma and is being evaluated in a phase IIa study. The company is also evaluating the drug in a phase II study to treat prostate cancer. Opaganib has also demonstrated a significant reduction of renal fibrosis in chronic kidney disease patients in pre-clinical studies.

Antiviral pills have been in the spotlight since last week when Merck (MRK - Free Report) and partner Ridgeback Biotherapeutics announced positive interim data from a phase III study on their oral antiviral medicine, molnupiravir.

Data from the study showed that treatment with molnupiravir reduced the risk of hospitalization or death by approximately 50% in non-hospitalized adult patients with mild or moderate COVID-19. Pfizer (PFE - Free Report) , Atea Pharmaceuticals (AVIR - Free Report) and Adamis Pharmaceuticals are also developing oral antiviral therapies for COVID-19.

Zacks Rank

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

You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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