Exela Technologies (XELA) FDA Approvals

Exela Technologies' Drug in the FDA Approval Process

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

Ulixacaltamide FDA Regulatory Events

Ulixacaltamide is a drug developed by Exela Technologies for the following indication: Designed to block abnormal neuronal burst firing in the Cerebello-Thalamo-Cortical (CTC) circuit correlated with tremor activity. 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.

Positive Results - October 16,2025

Phase 3

• Drug: Ulixacaltamide
• Announced Date: October 16, 2025
• Indication: Designed to block abnormal neuronal burst firing in the Cerebello-Thalamo-Cortical (CTC) circuit correlated with tremor activity.

Praxis Precision Medicines, Inc. announced positive topline results for the Phase 3 Essential3 program of ulixacaltamide in essential tremor (ET).

Praxis Precision Medicines announced positive topline results from its Phase 3 Essential3 program testing ulixacaltamide in adults with essential tremor (ET). The program enrolled over 700 patients in two decentralized U.S. studies.

In the 12-week, double-blind parallel-group Study 1, ulixacaltamide led to a 4.3-point mean improvement in the Modified Activities of Daily Living 11 at Week 8 (p < 0.0001). All key secondary measures—rate of disease improvement, Patient Global Impression of Change, and Clinical Global Impression of Severity—also showed highly significant benefits (p < 0.001). Study 2 met its primary endpoint for maintenance of effect versus placebo (p = 0.0369) and its first key secondary endpoint for improvement rate (p = 0.0042).

Ulixacaltamide was generally well tolerated, with no drug-related serious adverse events. Praxis submitted a pre-NDA meeting request to the FDA and will host an investor call on October 16 to discuss these results. If approved, ulixacaltamide could become the first targeted therapy to help ET patients improve daily function.

Exela Technologies FDA Events - Frequently Asked Questions

Has Exela Technologies received FDA approval?

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

What drugs has Exela Technologies submitted to the FDA?

In the past two years, Exela Technologies (XELA) has reported FDA regulatory activity for Ulixacaltamide.

What is the most recent FDA event for Exela Technologies?

The most recent FDA-related event for Exela Technologies occurred on October 16, 2025, involving Ulixacaltamide. The update was categorized as "Positive Results," with the company reporting: "Praxis Precision Medicines, Inc. announced positive topline results for the Phase 3 Essential3 program of ulixacaltamide in essential tremor (ET)."

What conditions do Exela Technologies' current drugs treat?

Currently, Exela Technologies has one therapy (Ulixacaltamide) targeting the following condition: Designed to block abnormal neuronal burst firing in the Cerebello-Thalamo-Cortical (CTC) circuit correlated with tremor activity..