RedHill Biopharma Ltd (RDHL)

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RedHill's (RDHL) RHB-204 Gets FDA Fast Track Designation
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https://finance.yahoo.com/news/redhills-rdhl-rhb-204-gets-142802639.html

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

Thu, January 7, 2021, 4:28 PM GMT+2
RedHill Biopharma Ltd. RDHL announced that the FDA has granted Fast Track designation to its product candidate, RHB-204, for the treatment of nontuberculous mycobacteria (NTM) disease. Pulmonary NTM disease is a chronic and debilitating lung disease.

Please note that the company is currently evaluating the candidate in a phase III study as a first-line, oral monotherapy for pulmonary NTM disease

Notably, the FDA provides a Fast Track designation to help the development and faster review of drugs, which treat serious and unmet medical conditions. The candidate also enjoys Qualified Infectious Disease Product (QIDP) designation and Orphan Drug designation in the United States.

The QIDP designation makes the company’s potential new drug application for the candidate eligible for priority review and accelerated approval. Moreover, the Orphan Drug designation extends the U.S. market exclusivity for RHB-204 for a potential total of 12 years upon FDA approval.

Shares of Redhill have increased 35.6% in the past year against the industry’s 3.8% decline.


The late-stage study evaluating RHB-204 will enroll 125 patients, randomized at a 3:2 ratio to receive either RHB-204 or placebo. The study is planned to evaluate the safety and efficacy of RHB-204, evaluating patient-reported outcomes and sputum culture conversion (SCC) by month 6 of treatment with the candidate compared to placebo. Patients will continue to receive treatment for 12 months from SCC.

Apart from RHB-204, RedHill is also evaluating another oral drug candidate, opaganib as potential treatment for patients hospitalized with COVID-19 pneumonia, advanced cholangiocarcinoma and prostate cancer in separate clinical studies.

Earlier this month, the company announced encouraging preliminary top-line data from an exploratory phase II study evaluating it for COVID-19 pneumonia. Following 14 days of treatment with opaganib, 52.6% of patients no longer required oxygen support versus 22.2% for placebo while 89.5% of patients achieved 50% reduction in supplemental oxygen compared to 66.7% for placebo. Moreover, 73.7% of patients were discharged by day 14 in the opaganib-arm compared to 55.6% for placebo. Median total oxygen requirement over 14 days was reduced by 68% in the opaganib-arm versus 46.7% for placebo.

Meanwhile, RedHill is set to start a phase II/III study on its second coronavirus candidate, RHB-107 for addressing patients with symptomatic COVID-19 who do not require hospitalization. The FDA cleared an investigational new drug application for the study in November.


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