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RedHill (RDHL) Expands Opaganib Manufacturing Capacity in US

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RedHill Biopharma Ltd. (RDHL - Free Report) announced that it has entered into a partnership with two manufacturers in the United States for the large-scale manufacturing of its novel investigational candidate opaganib, also called Yeliva. With this newly-formed collaboration, the company is preparing to file potential emergency use applications in the first quarter of 2021 for the orally administered opaganib, which is being developed to treat severe COVID-19 pneumonia.

Recently, RedHill forged similar partnerships with the European and Canadian manufacturers for manufacturing opaganib.

Shares of RedHill were up 2.2% following the above-mentioned news. In fact, the stock has rallied 41% so far this year against the industry’s decrease of 4%.

price chart for RDHL


We remind investors that earlier this month, RedHill completed enrollment in the phase II study, currently investigating opaganib in patients hospitalized with severe COVID-19 pneumonia in the United States. Top-line data from the same is expected in the coming weeks.

Meanwhile, a global phase II/III study on opaganib (administered orally) for severe COVID-19 already enrolled more than 50% of the total cohort and is on track to enroll all 270 patients. Top-line data is expected in the first quarter of 2021. Following a pre-scheduled safety review, the study was unanimously recommended to be continued by an independent Data and Safety Monitoring Board (DSMB).

Notably, apart from COVID-19, opaganib is being evaluated in a phase IIa study for treating advanced cholangiocarcinoma and in a phase II study for addressing prostate cancer.

We note that, earlier in the month, FDA granted Emergency Use Authorization (EUA) to Eli Lilly’s (LLY - Free Report) antibody drug bamlanivimab (LY-CoV555) as a monotherapy for treating the recently-diagnosed mild-to-moderate COVID-19 illness in patients who are at high risk of progressing to severe COVID-19 or hospitalization. The FDA also granted an EUA to Lilly and Incyte’s (INCY - Free Report) rheumatoid arthritis drug Olumiant (baricitinib) in combination with Veklury (remdesivir) in the same month for treating hospitalized patients with COVID-19 infection.

Also, the FDA gave an EUA to Regeneron’s (REGN - Free Report) antibody cocktail therapy, casirivimab and imdevimab administered together (REGN-COV2) for the treatment of mild-to-moderate 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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