Matinas BioPharma Holdings Inc. has been granted orphan drug designation for its fungicidal medication MAT2203 from the U.S. Food and Drug Administration.
![]() |
MAT2203 is an oral therapy under development to treat cryptococcosis, a life-threatening infection that typically occurs in the lungs of immuno-compromised people. The infection is caused by inhaling soil contaminated by a certain fungi. Matinas' oral therapy is a version of amphotericin B and targets infected tissues without the toxicity typically seen with this potent antifungal drug when iinjected.
Bedminster, N.J.-based Matinas said MAT2203 previously received qualified infectious disease product and fast-track designations from the U.S. regulator for three additional indications related to invasive fungal infections. With an orphan drug designation and qualified infectious disease product label for cryptococcosis, MAT2203 could be eligible for up to 12 years of market exclusivity.
The FDA grants orphan drug designations to therapies under development to treat diseases that affect fewer than 200,000 patients in the U.S. Drug developers can be eligible for up to seven years of market exclusivity if the drug is ultimately approved, plus certain tax credits, clinical trial design assistance and other perks.

