Celularity (CELU) FDA Approvals

Celularity's Drug in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by Celularity (CELU). Over the past two years, Celularity has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as PDA-002. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

PDA-002 FDA Regulatory Events

PDA-002 is a drug developed by Celularity for the following indication: For treating Facioscapulohumeral Muscular Dystrophy (FSHD). 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.

Publication - October 14,2025

Phase 2

• Drug: PDA-002
• Announced Date: October 14, 2025
• Indication: For treating Facioscapulohumeral Muscular Dystrophy (FSHD).

Celularity Inc. announced the publication of its Phase 2 study titled "Human Placenta-Derived Cells (PDA-002) in Diabetic Foot Ulcer Patients With and Without Peripheral Artery Disease: A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial," in the International Wound Journal.

Celularity Inc. announced the publication of its Phase 2 study of PDA-002 in diabetic foot ulcer patients with and without peripheral artery disease (PAD) in the International Wound Journal. This trial tested the safety and effectiveness of PDA-002, a placenta-derived cell therapy, in complex wounds among diabetic patients.

The study enrolled 159 adults across 35 U.S. sites. Participants received two intramuscular doses of PDA-002 at three dose levels or placebo. The main goal was complete wound closure within three months with healing lasting at least four more weeks. In PAD patients, the lowest dose (3 × 10^6 cells) achieved a 38.5% closure rate versus 22.6% with placebo. Treated patients healed faster, had fewer cases of gangrene and infections, and had no serious side effects over two years. These findings support further trials to confirm PDA-002 as a novel regenerative therapy for hard-to-treat diabetic ulcers.

Celularity FDA Events - Frequently Asked Questions

Has Celularity received FDA approval?

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

What drugs has Celularity submitted to the FDA?

In the past two years, Celularity (CELU) has reported FDA regulatory activity for PDA-002.

What is the most recent FDA event for Celularity?

The most recent FDA-related event for Celularity occurred on October 14, 2025, involving PDA-002. The update was categorized as "Publication," with the company reporting: "Celularity Inc. announced the publication of its Phase 2 study titled "Human Placenta-Derived Cells (PDA-002) in Diabetic Foot Ulcer Patients With and Without Peripheral Artery Disease: A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial," in the International Wound Journal."

What conditions do Celularity's current drugs treat?

Currently, Celularity has one therapy (PDA-002) targeting the following condition: For treating Facioscapulohumeral Muscular Dystrophy (FSHD)..