trending Market Intelligence /marketintelligence/en/news-insights/trending/9um3obo_wdcEd2mvIj1A0w2 content esgSubNav
In This List

Matinas granted US FDA's orphan drug designation for oral antifungal therapy

Blog

A Pharmaceutical Company Capitalizes on M&A Activity with Brokerage Research

Blog

2021 Year in Review: Highlighting Key Investment Banking Trends

Blog

Insight Weekly: US stock performance; banks' M&A risk; COVID-19 vaccine makers' earnings

Blog

Global M&A By the Numbers: Q3 2021


Matinas granted US FDA's orphan drug designation for oral antifungal therapy

Matinas BioPharma Holdings Inc. has been granted orphan drug designation for its fungicidal medication MAT2203 from the U.S. Food and Drug Administration.

SNL Image

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.