Matinas BioPharma Plans To Meet With FDA In Q1 To Finalize Phase 3 Protocol For MAT2203

(RTTNews) - Matinas BioPharma Holdings, Inc. announced receipt of written feedback from FDA on its proposed revised protocol for a Phase 3 study of MAT2203 in patients with invasive aspergillosis with limited or no treatment options. The company noted that the preliminary written comments move it closer to alignment with FDA on the design of a single Phase 3 registration trial for the approval of MAT2203. At the FDA's invitation, the company is planning a meeting early in the first quarter of 2024 to discuss and finalize the Phase 3 protocol.

Jerome Jabbour, CEO of Matinas, said: "The latest feedback from FDA has moved us closer to agreement, and we believe accepting the FDA's invitation for a meeting in early 2024 will be the final step in achieving full alignment with FDA."

Shares of Matinas BioPharma are up 3% in pre-market trade on Thursday.

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