Ernexa Therapeutics (ERNA) has upcoming FDA regulatory milestones for IL-15. The table below outlines estimated target dates and event types for these pending regulatory actions.
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-201, 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-201 FDA Regulatory Events
ERNA-201 is a drug developed by Ernexa Therapeutics for the following indication: its synthetic, allogeneic induced mesenchymal stem cell (iMSC) therapy.
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-201
- Announced Date:
- September 15, 2026
- Indication:
- its synthetic, allogeneic induced mesenchymal stem cell (iMSC) therapy
Announcement
Ernexa Therapeutics announced positive preliminary preclinical results for ERNA-201, its synthetic, allogeneic induced mesenchymal stem cell (iMSC) therapy engineered to express anti-inflammatory factors, while outlining a sharpened oncology strategy designed to accelerate the Company's transition into the clinic and expand the long-term potential of its proprietary synthetic iMSC platform.
Read Announcement
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:
- July 15, 2026
- Indication:
- In Ovarian Cancer
Announcement
Ernexa Therapeutics announced compelling new preclinical data independently validating the anti-tumor activity of its lead cell therapy candidate, ERNA-101, in combination with PD-1 checkpoint inhibition.
AI Summary
Ernexa Therapeutics said new preclinical data independently confirmed the strong anti-tumor effect of its lead cell therapy, ERNA-101, when paired with PD-1 checkpoint inhibition. In a larger study run by an independent contract research organization, the combination cleared tumors and led to long-term survival in 10 of 15 treated animals, or 67%. No complete responses or lasting survival were seen in animals given ERNA-101 alone, anti-PD-1 alone, or no treatment. The study used an immune-competent ovarian cancer model and tracked tumor growth with imaging over time. Ernexa said the results strongly support a synergistic effect between ERNA-101 and PD-1 blockade. The company said this independent validation increases confidence in the therapy as it moves toward clinical testing, with an IND filing planned for the third quarter of 2026 and a Phase 1 trial expected to begin in the fourth quarter of 2026.
Read Announcement- Drug:
- ERNA-101
- Announced Date:
- June 17, 2026
- Indication:
- In Ovarian Cancer
Announcement
Ernexa Therapeutics highlighted significant progress across manufacturing, regulatory and clinical development activities supporting ERNA-101, the Company's lead oncology candidate.
AI Summary
Ernexa Therapeutics said it has made major progress in manufacturing, regulatory, and clinical development for ERNA-101, its lead cancer drug candidate. The company has finished manufacturing process development, started GMP production, and is moving ahead with IND-enabling studies. Ernexa plans to submit its Investigational New Drug application in the third quarter of 2026.
If the review goes well, Ernexa expects to begin its first human Phase 1 study in the fourth quarter of 2026. The first trial would test ERNA-101 in platinum-resistant ovarian cancer, with first patient enrollment planned soon after. The company says these steps could help it move from a development-stage company into a clinical-stage biotech.
ERNA-101 is designed to help “cold” tumors become more visible to the immune system by delivering cytokines directly into the tumor area and boosting T cell and NK cell activity. Ernexa also said recent funding supports its near-term goals.
Read Announcement- Drug:
- ERNA-101
- Announced Date:
- June 9, 2026
- Indication:
- In Ovarian Cancer
Announcement
Ernexa Therapeutics announced the participation in a Virtual Investor KOL Connect segment featuring Ira S. Winer, MD, PhD, FACOG, Scientific Advisory Board Member at Ernexa Therapeutics, Professor in the Division of Gynecologic Oncology at Wayne State University School of Medicine and gynecologic oncologist at the Barbara Ann Karmanos Cancer Institute.
AI Summary
Ernexa Therapeutics announced a Virtual Investor KOL Connect segment featuring Scientific Advisory Board member Ira S. Winer, MD, PhD, FACOG. Dr. Winer, a professor at Wayne State University School of Medicine and gynecologic oncologist at the Barbara Ann Karmanos Cancer Institute, discussed the major unmet need in ovarian cancer and the limits of current treatments.
He also highlighted the challenge of treating “cold” tumors, which often do not respond well to immune therapies. The discussion covered how immune and cell therapies are evolving in solid tumors and why scalable, off-the-shelf engineered cell therapies could help make treatment easier to produce and more accessible for patients.
The segment pointed to Ernexa’s engineered allogeneic induced mesenchymal stem cell platform as a possible way to address manufacturing challenges while supporting future cancer treatment options.
Read Announcement- Drug:
- ERNA-101
- Announced Date:
- May 27, 2026
- Indication:
- In Ovarian Cancer
Announcement
Ernexa Therapeutics nnounced 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.
AI Summary
Ernexa Therapeutics said it has made important progress on ERNA-101, its lead cell therapy candidate, and is moving closer to clinical testing. The company completed process development for how ERNA-101 will be made and has now entered Good Manufacturing Practice, or GMP, manufacturing to prepare for studies in people. It also began technology transfer work, another key step that supports the plan to file an Investigational New Drug application in the third quarter of 2026.
CEO Sanjeev Luther said these milestones show the company is entering a major new phase and is becoming more ready for clinical development. ERNA-101 is designed to help the immune system recognize and attack cancer cells, with ovarian cancer as the first target. Ernexa said the work reflects growing momentum across its operations and strengthens its path toward its first human trial.
Read Announcement- Drug:
- ERNA-101
- Announced Date:
- May 6, 2026
- Indication:
- In Ovarian Cancer
Announcement
Ernexa Therapeutics announced new preclinical data demonstrating that its lead cell therapy candidate, ERNA-101, in combination with PD-1 blockade, drives complete tumor clearance and 100% long-term survival in syngeneic ovarian cancer models.
AI Summary
Ernexa Therapeutics reported preclinical data showing that ERNA-101 combined with PD-1 blockade produced complete tumor clearance by bioluminescence imaging and 100% long-term survival in syngeneic ovarian cancer models. These outcomes far exceeded those seen with either therapy alone and suggest potential curative activity. The studies also showed ERNA-101 remodels the tumor microenvironment from immunosuppressive to immune-activated, enabling strong and sustained anti-tumor immune responses.
ERNA-101 is an allogeneic induced mesenchymal stem cell (iMSC) therapy derived from iPSCs and engineered to home to tumors and secrete a fused IL-7/IL-15 cytokine directly within the tumor microenvironment. This localized cytokine delivery aims to boost immune activation while limiting systemic toxicity. Ernexa plans to advance ERNA-101 toward a first-in-human trial in advanced ovarian cancer and is continuing preclinical studies testing combinations with checkpoint inhibitors and other immuno-oncology agents.
Read Announcement- 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 Timeline and 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:
- July 7, 2026
- Target Action Date:
- Q4 2026
- Estimated Target Date Range:
- October 1, 2026 - December 31, 2026
- Indication:
- In ovarian tumors
Announcement
Teva Pharmaceutical Industries Ltd. announced plans to advance its TEV-’408, an investigational anti-interleukin-15 monoclonal antibody, into a Phase 2b study in vitiligo in the fourth quarter of 2026.
AI Summary
Teva Pharmaceutical Industries said it plans to move its experimental drug TEV-’408 into a Phase 2b vitiligo study in the fourth quarter of 2026. TEV-’408 is an anti-interleukin-15 monoclonal antibody designed to block immune activity that can damage pigment-making skin cells. The decision comes after encouraging Phase 1b results in adults with active or stable non-segmental vitiligo.
In the study, the drug was well tolerated, and no safety signals have been seen so far. By week 24, many patients showed signs of improved skin color. Nearly 75% reported better facial vitiligo, and 55% reported improvement across the body. Some patients also reached strong clinical response levels measured by VASI scores. Teva says vitiligo remains a disease with limited treatment options, especially for people with more widespread disease.
Read Announcement- 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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