Business
Ernexa Therapeutics Successfully Completes Key Manufacturing and IND Preparation Milestones for ERNA-101 Toward First-in-Human Clinical Development
Company remains on track for anticipated IND filing in Q3 2026, marking a transformative step toward becoming a clinical-stage biotechnology companyCAMBRIDGE, Mass., May 27, 2026 (GLOBE NEWSWIRE) -- Ernexa Therapeutics (Nasdaq: ERNA), an industry innovator developing novel cell therapies for the treatment of advanced cancer and autoimmune disease, today announced significant progress in the development of ERNA-101, the company’s lead therapeutic candidate, achieving multiple critical milestones
About this update from Ernexa Therapeutics Inc.
[{"type":"image","alt":"Ernexa Therapeutics Inc.","displaySize":"","headline":null,"caption":"Ernexa Therapeutics Inc.","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":166,"url":"https://media.zenfs.com/en/globenewswire.com/5060d0692cdc61118022bf7e5069f69d"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/rPkfplzjWf7QJtOONs839w--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTIzMg--/https://media.zenfs.com/en/globenewswire.com/5060d0692cdc61118022bf7e5069f69d","width":300,"height":166},"resize_sm":{"url":"https://s.yimg.com/ny/api/res/1.2/rPkfplzjWf7QJtOONs839w--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTIzMg--/https://media.zenfs.com/en/globenewswire.com/5060d0692cdc61118022bf7e5069f69d","width":300,"height":166}},"lazy":false},{"type":"text","content":"Company remains on track for anticipated IND filing in Q3 2026, marking a transformative step toward becoming a clinical-stage biotechnology company","length":148,"tagName":"p"},{"type":"text","content":"CAMBRIDGE, Mass., May 27, 2026 (GLOBE NEWSWIRE) -- Ernexa Therapeutics (Nasdaq: ERNA), an industry innovator developing novel cell therapies for the treatment of advanced cancer and autoimmune disease, today announced significant progress in the development of ERNA-101, the company’s lead therapeutic candidate, achieving multiple critical milestones that position the program for a planned Investigational New Drug (IND) submission in the third quarter of 2026 and the anticipated initiation of its first-in-human clinical study.","length":531,"tagName":"p"},{"type":"text","content":"The company has successfully completed process development activities for the ERNA-101 manufacturing process and has now transitioned into Good Manufacturing Practice (GMP) manufacturing in preparation for clinical development. In parallel, technology transfer activities for ERNA-101 are actively underway, representing another major operational milestone supporting the planned IND submission timeline.","length":404,"tagName":"p"},{"type":"text","content":"“These achievements represent a defining moment for Ernexa Therapeutics,” said Sanjeev Luther, CEO of Ernexa Therapeutics. “Completing process development and advancing into GMP manufacturing are critical steps toward IND clearance and the launch of our first-in-human clinical study for ERNA-101. We are executing against our development strategy with urgency a...