Liminatus Pharma (LIMN) FDA Events

Liminatus Pharma's Drug in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by Liminatus Pharma (LIMN). Over the past two years, Liminatus Pharma has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as IBA101. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

IBA101 FDA Regulatory Events

IBA101 is a drug developed by Liminatus Pharma for the following indication: next-generation CD47 antibody. 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.

Provided Update - June 24,2025

• Drug: IBA101
• Announced Date: June 24, 2025
• Indication: next-generation CD47 antibody

Liminatus announced that it has been preparing to redefine the immune-oncology landscape with IBA101, a novel CD47 checkpoint inhibitor engineered to eliminate the anemia and thrombocytopenia that halted earlier candidates.

Liminatus Pharma is preparing to redefine the immune-oncology landscape with its novel CD47 checkpoint inhibitor, IBA101. Unlike earlier candidates, IBA101 is engineered to avoid side effects such as anemia and thrombocytopenia by sparing red blood cells and platelets. This is achieved through precise epitope selection and Fc engineering, allowing for higher dosing levels and potentially a more effective anti‑tumor response. Preclinical studies in non‑human primates have shown promising safety, with no significant reductions in hemoglobin or platelet counts. By blocking the “don’t‑eat‑me” signal on tumor cells, IBA101 reactivates the body’s immune clearance system, which may lead to more robust immune responses against cancer. Liminatus’ progress marks an important step toward safer and more potent immunotherapy, with upcoming clinical trials planned in both the United States and Korea.

Liminatus Pharma FDA Events - Frequently Asked Questions

Has Liminatus Pharma received FDA approval?

As of now, Liminatus Pharma (LIMN) has not received any FDA approvals for its therapy in the last two years.

What drugs has Liminatus Pharma submitted to the FDA?

In the past two years, Liminatus Pharma (LIMN) has reported FDA regulatory activity for IBA101.

What is the most recent FDA event for Liminatus Pharma?

The most recent FDA-related event for Liminatus Pharma occurred on June 24, 2025, involving IBA101. The update was categorized as "Provided Update," with the company reporting: "Liminatus announced that it has been preparing to redefine the immune-oncology landscape with IBA101, a novel CD47 checkpoint inhibitor engineered to eliminate the anemia and thrombocytopenia that halted earlier candidates."

What conditions do Liminatus Pharma's current drugs treat?

Currently, Liminatus Pharma has one therapy (IBA101) targeting the following condition: next-generation CD47 antibody.