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.
- 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.
Announcement
Praxis Precision Medicines, Inc. announced positive topline results for the Phase 3 Essential3 program of ulixacaltamide in essential tremor (ET).
AI Summary
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.
Read Announcement
Exela Technologies FDA Events - Frequently Asked Questions
As of now, Exela Technologies (XELA) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Exela Technologies (XELA) has reported FDA regulatory activity for Ulixacaltamide.
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)."
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..
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:XELA) was last updated on 10/20/2025 by MarketBeat.com Staff
