- The European Commission granted orphan drug status to RedHill Biopharma Ltd's RDHL RHB-2041 for nontuberculous mycobacteria (NTM) disease.
- NTM is a lung disease caused by ubiquitous environmental bacteria in soil and natural and engineered water systems.
- The move follows a positive opinion recommendation by the European Medicines Agency's (EMA) Committee for Orphan Medicinal Products.
- The EMA grants Orphan status to treatments that affect not more than five in 10,000 people in the European Union). Orphan Designation provides free protocol assistance), potential reductions in fees and eligibility for ten years post-launch market exclusivity.
- A U.S. Phase 3 study is ongoing to evaluate the efficacy and safety of RHB-204 in adults with pulmonary NTM.
- The company is advancing discussions with prospective partners for RHB-204 across multiple territories.
- RHB-204 was granted FDA Fast Track and Orphan Drug Designation. RHB-204 is also covered by U.S. patents which extend patent protection until 2029, and a pending U.S. patent application which, if allowed, could extend RHB-204 patent protection until 2041.
- Price Action: RDHL shares are up 4.14% at $1.02 on the last check Wednesday.
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