This section highlights FDA-related milestones and regulatory updates for drugs developed by Ernexa Therapeutics (ERNA).
Over the past two years, Ernexa Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
ERNA-101 and IL-15. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
ERNA-101 FDA Regulatory Timeline and Events
ERNA-101 is a drug developed by Ernexa Therapeutics for the following indication: In Ovarian Cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ERNA-101
- Announced Date:
- March 31, 2026
- Indication:
- In Ovarian Cancer
Announcement
Ernexa Therapeutics today provided a business update highlighting the Company's accelerating transition toward clinical development and a series of upcoming milestones expected to serve as key value-inflection points over the next 12-18 months.
AI Summary
Ernexa Therapeutics said it is accelerating its move into clinical development and expects a string of regulatory and clinical milestones to drive value over the next 12–18 months. The company is finishing final steps to support an IND submission for its lead cell therapy, ERNA-101.
Preclinical data showed deep, durable tumor regressions when ERNA-101 was combined with PD-1 blockade in ovarian cancer. Ernexa plans an IND filing in Q3 2026 and a first-in-human study in Q4 2026 focused on platinum-resistant ovarian cancer, marking a major transition from lab to clinic.
Separately, Ernexa continues to advance ERNA-201, an engineered iMSC designed to deliver IL-10 to inflamed tissues for autoimmune diseases like rheumatoid arthritis.
Backed by a recent $10.5 million financing, the company says these upcoming milestones and its engineered iMSC platform could be key value-inflection points as it enters a pivotal execution phase.Read Announcement
- Drug:
- ERNA-101
- Announced Date:
- January 6, 2026
- Indication:
- In Ovarian Cancer
Announcement
Ernexa Therapeutics announced the successful completion of its recent Pre-Investigational New Drug Application (Pre-IND) meeting with the U.S. Food and Drug Administration (FDA).
AI Summary
Ernexa Therapeutics announced it successfully completed a Pre-IND meeting with the U.S. Food and Drug Administration. The FDA’s feedback gave strong regulatory alignment on Ernexa’s development approach and laid out a clear pathway to submit an IND and begin a first‑in‑human (FIH) trial for ovarian cancer in the second half of 2026.
After the meeting, Ernexa sped up key operations. Technology transfer—an important step to prepare for clinical manufacturing—is already underway. This work is intended to accelerate production of clinical‑grade material and drive the company toward trial readiness.
Ernexa plans to start its initial clinical work with ERNA‑101 for ovarian cancer. The company says the FDA alignment and active tech transfer position it to move quickly into human studies and advance its off‑the‑shelf cell therapy program.
Read Announcement- Drug:
- ERNA-101
- Announced Date:
- December 8, 2025
- Indication:
- In Ovarian Cancer
Announcement
Ernexa Therapeutics announced the presentation of new preclinical data on its lead cell therapy candidate, ERNA-101, at the American Society of Hematology (ASH) Annual Meeting.
AI Summary
Ernexa Therapeutics reported new preclinical data on its lead cell therapy, ERNA-101, at the ASH Annual Meeting showing its platform can quickly and durably reprogram immunosuppressive tumor microenvironments (TMEs) into pro‑inflammatory, immune‑active states. The approach uses engineered induced pluripotent stem cells (iPSCs) converted into induced mesenchymal stem cells (iMSCs) that secrete IL‑7 and IL‑15. These iMSCs produced cytokine levels roughly 20‑fold higher than prior engineered T‑cell methods, driving strong T‑cell expansion, sustained STAT5 signaling, and activation of survival pathways important for immune persistence.
In an immunocompetent ovarian cancer model, intraperitoneal delivery of IL‑7/IL‑15 iMSCs increased immune cell infiltration, shifted macrophages to a pro‑inflammatory state, prolonged survival, and converted “cold” tumors into “hot” ones that are more likely to respond to immunotherapy. Ernexa emphasizes a scalable, off‑the‑shelf allogeneic iMSC strategy and plans to advance ERNA‑101 toward first‑in‑human trials next year.Read Announcement
- Drug:
- ERNA-101
- Announced Date:
- January 14, 2025
- Indication:
- In Ovarian Cancer
Announcement
Eterna Therapeutics announced positive results from a preclinical study on the company's lead cell therapy product, ERNA-101, which is designed to activate and regulate the immune system's response to recognize and attack ovarian cancer cells.
AI Summary
Eterna Therapeutics recently announced positive preclinical results for its lead cell therapy product, ERNA-101, which is designed to activate and regulate the immune system to target ovarian cancer cells. In a proof-of-concept study, a single dose of ERNA-101 led to massive T cell infiltration in treated mice, which helped reduce tumor burden and extend survival compared to control groups.
The therapy works by transforming the tumor microenvironment from "cold" (inactive) to "hot" (active), potentially increasing the effectiveness of additional treatments like CAR-T and CAR-NK cell therapies. ERNA-101 uses induced pluripotent stem cells (iPSCs) to produce mesenchymal stem cells that secrete interleukins IL-7 and IL-15, promoting a stronger immune response directly at the tumor site. These encouraging results mark a significant milestone in the preclinical development of this innovative therapeutic approach for ovarian cancer.
Read Announcement
IL-15 FDA Regulatory Events
IL-15 is a drug developed by Ernexa Therapeutics for the following indication: In ovarian tumors.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- IL-15
- Announced Date:
- June 2, 2025
- Indication:
- In ovarian tumors
Announcement
Calidi Biotherapeutics Inc. announced the presentation of its lead RedTail platform candidate, CLD-401, at the American Society of Clinical Oncology (ASCO) Annual Meeting.
AI Summary
Calidi Biotherapeutics Inc. recently presented its lead candidate, CLD-401, at the American Society of Clinical Oncology (ASCO) Annual Meeting. This candidate is the first therapeutic from their innovative RedTail platform, which uses an engineered oncolytic virus for systemic delivery. At ASCO, new data showed that CLD-401 has a unique genetic modification where a chimeric CD55 receptor is incorporated into the viral envelope. This change helps protect the virus from rapid clearance by the body’s immune system, allowing it to circulate longer after being administered intravenously. Additionally, CLD-401 is designed to deliver an IL-15 superagonist directly into the tumor microenvironment. The IL-15 superagonist is known to activate key immune cells, such as natural killer cells and CD8+ T cells, potentially leading to a strong antitumor response.
Read Announcement- Drug:
- IL-15
- Announced Date:
- May 28, 2025
- Target Action Date:
- June 2, 2025
- Indication:
- In ovarian tumors
Announcement
Ernexa Therapeutics announced that new data will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting 2025 on June 2 in Chicago.
AI Summary
Ernexa Therapeutics announced that new research data will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting 2025, scheduled for June 2 in Chicago. The study focuses on their innovative iMSC-based immunotherapy platform, which uses induced mesenchymal stem cells engineered to secrete cytokines IL-7 and IL-15 directly within ovarian tumors.
The approach exploits these engineered cells—derived from adult skin cells—to stimulate a strong immune response by converting “cold” tumors that lack immune cells into “hot” tumors rich in T cells and macrophages. Early preclinical testing in an ovarian cancer mouse model has shown promise, including significant reductions in tumor burden and extended survival. Attendees at ASCO will have the opportunity to review the data and discuss its potential to improve treatment options for patients with challenging cancers.
Read Announcement
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