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RedHill's (RDHL) RHB-204 Gets FDA Orphan Drug Designation

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RedHill Biopharma Ltd. (RDHL - Free Report) announced that the FDA has granted Orphan Drug 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. Shares of the company have surged 66% against the industry’s 5.9% decline.

Notably, the Orphan Drug designation is granted to drugs that are capable of treating rare diseases that affect less than 200,000 people in the United States. This tag also makes the company entitled to certain other benefits, including tax credits related to clinical trial expenses, an exemption from the FDA user fee and a designated period of market exclusivity following approval.The Orphan Drug designation extends the U.S. market exclusivity for RHB-204 by an additional seven years, for a potential total of 12 years upon FDA approval.

The company expects to initiate a phase III study of RHB-204 in patients with pulmonary NTM infections in the coming weeks in the United States. The study aims to 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.

Previously, RHB-204 was granted a Qualified Infectious Disease Product (QIDP) designation by the FDA, providing eligibility for fast-track development, a priority review of the new drug application (NDA) and a five-year extension of U.S. market exclusivity, if approved.

Zacks Rank and Stocks to Consider

RedHill currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the healthcare sector includeAmneal Pharmaceuticals, Inc. (AMRX - Free Report) , AcelRx Pharmaceuticals, Inc. (ACRX - Free Report) and Auris Medical Holding Ltd. , all carryinga Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Amneal’s earnings per share estimates have increased from 57 cents to 59 cents for 2020 and from 68 cents to 71 cents for 2021 over the past 90 days. Shares of the company have increased 1.4% year to date.

AcelRx’s loss per share estimates have narrowed from 58 cents to 44 cents for 2020 over the past 90 days. Shares of the company have decreased 12.3% year to date.

Auris’ loss per share estimates have narrowed from $2.55 to $1.00 for 2020 and from $4.00 to $2.15 for 2021 over the past 90 days. Shares of the company have decreased 35.2% year to date.


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