Upcoming FDA Events for Exela Technologies
Exela Technologies (XELA) has upcoming FDA regulatory milestones for Ulixacaltamide. The table below outlines estimated target dates and event types for these pending regulatory actions.
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 Timeline and 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:
- April 14, 2026
- Target Action Date:
- January 29, 2027
- 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 that FDA assigned PDUFA target action date of January 29, 2027
AI Summary
Praxis Precision Medicines announced that the FDA has set a PDUFA target action date of January 29, 2027, for its candidate ulixacaltamide. The company said the agency does not expect to hold an advisory committee meeting in connection with the review. This date is when the FDA aims to complete its review and issue a decision on approval.
Ulixacaltamide is being developed to treat essential tremor. It is a small molecule that selectively blocks T-type calcium channels to reduce abnormal burst firing in the cerebello-thalamo-cortical circuit, which is linked to tremor activity. Praxis describes the drug as a therapy designed specifically for people living with essential tremor.
Praxis’ CEO Marcio Souza said the announcement moves the company closer to delivering a therapy for patients, and that Praxis will continue working with the FDA through the review while preparing for a potential commercial launch.
Read Announcement- Drug:
- Ulixacaltamide
- Announced Date:
- April 14, 2026
- 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 that the U.S. Food and Drug Administration (FDA) has accepted for review its New Drug Application (NDA) for ulixacaltamide HCl for the treatment of essential tremor (ET) in adults.
AI Summary
Praxis Precision Medicines announced the U.S. Food and Drug Administration has accepted for review its New Drug Application for ulixacaltamide HCl to treat essential tremor in adults. The FDA set a PDUFA target action date of January 29, 2027, and does not expect to hold an advisory committee meeting as part of the review.
Praxis said the company will continue working with the FDA through the review process while preparing for a potential commercial launch. Company leadership described the acceptance as an important step toward offering a therapy developed specifically for people with essential tremor.
Ulixacaltamide is a selective small molecule designed to inhibit T-type calcium channels and reduce abnormal neuronal burst firing in the cerebello-thalamo-cortical circuit linked to tremor. Praxis is advancing this program as a key part of its small molecule CNS development efforts.
Read Announcement- Drug:
- Ulixacaltamide
- Announced Date:
- April 13, 2026
- 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 it will present expanded analyses from the Phase 3 Essential3 program of ulixacaltamide in essential tremor, alongside new data from its advancing CNS pipeline, at the 2026 AAN Annual Meeting, taking place April 18–22, 2026, in Chicago, Illinois.
AI Summary
Praxis Precision Medicines will present expanded analyses from the Phase 3 Essential3 program of ulixacaltamide in essential tremor, along with new data from its advancing CNS pipeline, at the 2026 AAN Annual Meeting in Chicago (April 18–22). The Essential3 data have been selected for a plenary presentation, highlighting topline and durability findings.
The company plans 15 scientific presentations at AAN, including a plenary on Essential3, three oral presentations and 12 posters. Praxis will host an in‑booth speaker showcase at Booth #2324 to review the Phase 3 results and enable scientific exchange on essential tremor and related CNS programs.
Essential tremor affects roughly 7 million people in the U.S. Ulixacaltamide is a selective small molecule T‑type calcium channel inhibitor designed to reduce abnormal neuronal burst firing linked to tremor, and the Essential3 analyses aim to show meaningful improvements in daily function and maintenance of response.
Read Announcement- Drug:
- Ulixacaltamide
- Announced Date:
- December 29, 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 that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for ulixacaltamide, a differentiated and highly selective small molecule inhibitor of T-type calcium channels, for the treatment of patients with essential tremor (ET).
AI Summary
Praxis Precision Medicines announced that the U.S. Food and Drug Administration granted Breakthrough Therapy Designation (BTD) to ulixacaltamide, a differentiated, highly selective small‑molecule inhibitor of T‑type calcium channels, for the treatment of essential tremor (ET). The BTD was based on positive topline results from the Essential3 Phase 3 program, which included two pivotal studies that showed meaningful effects on tremor‑related endpoints.
BTD is meant to accelerate development and review for therapies addressing serious conditions when early clinical evidence suggests a substantial improvement over available treatments. Ulixacaltamide is designed to block abnormal neuronal burst firing in the cerebello‑thalamo‑cortical circuit linked to tremor. With limited approved options and many patients inadequately controlled, the designation highlights the drug’s potential to meet a significant unmet need in ET care.
Read Announcement- 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 April 14, 2026, involving Ulixacaltamide. The update was categorized as "FDA Accepted," with the company reporting: "Praxis Precision Medicines, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for review its New Drug Application (NDA) for ulixacaltamide HCl for the treatment of essential tremor (ET) in adults."
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..
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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
FDA progress for NASDAQ:XELA last updated on 4/14/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data.
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