- A committee of the European Medicines Agency (EMA) recommended granting orphan medicinal product designation to Matinas BioPharma's ( NYSE: MTNB ) MAT2203 to treat a type of fungal infection called cryptococcosis.
- The EMA's Committee for Orphan Medicinal Products had issued the positive positive opinion.
- The company said it is preparing to evaluate MAT2203 in a phase 3 trial to treat patients with cryptococcal meningitis — an infection caused by a fungus known as Cryptococcosis neoformans.
- In the EU, the orphan drug status is given to therapies aimed at treating or preventing a serious or life-threatening disease which affects not more than five in 10K people in the EU. The designation has benefits, including 10 years of market exclusivity for the product, if approved.
- MAT2203 has already received the U.S. FDA's orphan, qualified infectious disease product (QIDP) and fast track designations to treat cryptococcosis, and three other uses: treat invasive candidiasis, invasive aspergillosis, and to prevent invasive fungal infections due to immunosuppressive therapy, according to the company's July 25 press release.
- MTNB +4.59% to $0.90 premarket July 25
For further details see:
Matinas stock rises as MAT2203 gets EMA panel nod for orphan drug status