Eterna Therapeutics (ERNA) said Tuesday it is on track to initiate its first-in-human ovarian cancer trial in H2 2026.
The company said it recently concluded a pre-investigational new drug application meeting with the US Food and Drug Administration, with feedback from the agency setting a pathway for submitting an investigational new drug application.
Eterna said that following the meeting, it has boosted key operational activities, with tech transfer already underway.
The company said it is currently progressing ERNA-101 therapy for ovarian cancer and ERNA-201 for autoimmune disease.
Ernexa Therapeutics shares were down 4% in recent Tuesday premarket activity.