FDA Events for Quince Therapeutics (QNCX)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Quince Therapeutics (QNCX).
Over the past two years, Quince Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
EryDex. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
EryDex - FDA Regulatory Timeline and Events
EryDex is a drug developed by Quince Therapeutics for the following indication: For the Treatment of Ataxia-Telangiectasia.
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:
- EryDex
- Announced Date:
- June 25, 2025
- Indication:
- For the Treatment of Ataxia-Telangiectasia
Announcement
Quince Therapeutics, Inc announced its participation at the upcoming 2025 A-T Clinical Research Conference organized by the A-T Society, a leading Ataxia-Telangiectasia (A-T) patient advocacy group based in the United Kingdom.
AI Summary
Quince Therapeutics, Inc. announced its participation in the 2025 A-T Clinical Research Conference organized by the A-T Society in the United Kingdom. The conference will take place from June 25-27, 2025, at Loughborough University and is a key event for the Ataxia-Telangiectasia (A-T) community. Leading experts will present data from Quince’s previous Phase 3 ATTeST clinical trial for eDSP, a treatment developed for A-T patients. Additionally, Quince’s management is set to discuss the progress of their pivotal Phase 3 NEAT clinical trial, which currently has 99 participants enrolled. This participation underscores Quince’s commitment to advancing research in A-T and highlights the company’s efforts to bring innovative treatment options to patients in need.
Read Announcement - Drug:
- EryDex
- Announced Date:
- March 24, 2025
- Indication:
- For the Treatment of Ataxia-Telangiectasia
Announcement
Quince Therapeutics, Inc Provides Business Update
AI Summary
Quince Therapeutics, Inc. provided a business update on its Phase 3 NEAT clinical trial for Ataxia-Telangiectasia (A-T). The study, which is being conducted under a Special Protocol Assessment with the FDA, has passed the halfway mark with over 50% enrollment—71 participants screened and 61 randomized so far. New study site activations in various geographic regions are expected to accelerate screenings and randomization, with the trial aiming to reach target enrollment by mid-2025.
The company anticipates reporting topline results in the fourth quarter of 2025, followed by an NDA submission to the FDA and an MAA submission to the EMA in 2026, assuming positive results. Quince Therapeutics currently holds $40.8 million, which is projected to fund operations through the NEAT trial’s topline results and into 2026.
Read Announcement- Drug:
- EryDex
- Announced Date:
- January 27, 2025
- Indication:
- For the Treatment of Ataxia-Telangiectasia
Announcement
Quince Therapeutics, Inc announced the online publication of safety data from patients with Ataxia-Telangiectasia (A-T) treated with EryDex for a minimum of 24 months in Frontiers in Neurology.
AI Summary
Quince Therapeutics recently published important safety data in the journal Frontiers in Neurology. The study focused on patients with Ataxia-Telangiectasia (A-T) who have been treated with EryDex for at least 24 months. EryDex works by delivering a form of dexamethasone inside a patient’s own red blood cells, which may help minimize the side effects usually seen with long-term steroid use. The findings from this extended clinical evaluation show that patients did not experience many of the severe side effects typically linked to prolonged corticosteroid treatment, such as rapid weight gain, high blood pressure, or growth problems. This publication builds on over a decade of experience with more than 6,000 doses, strengthening the safety profile of EryDex as Quince Therapeutics continues its development for treating A-T.
Read Announcement- Drug:
- EryDex
- Announced Date:
- August 15, 2024
- Indication:
- For the Treatment of Ataxia-Telangiectasia
Announcement
Quince Therapeutics, Inc announced the online publication of data in The Lancet Neurology from its Phase 3 ATTeST (Ataxia-Telangiectasia Trial with the EryDex SysTem; #IEDAT-02-2015/NCT02770807) clinical trial evaluating the safety and efficacy of its lead asset, EryDex (dexamethasone sodium phosphate encapsulated in autologous erythrocytes), for the treatment of A-T.
AI Summary
Quince Therapeutics announced the online publication of Phase 3 ATTeST trial data in The Lancet Neurology. The trial evaluated the safety and efficacy of EryDex—a formulation that encapsulates dexamethasone sodium phosphate in patients’ own red blood cells—for treating ataxia-telangiectasia (A-T), a rare pediatric disorder that causes progressive neurological decline. The study, the largest ever in A-T with 175 participants across 22 sites in 12 countries, demonstrated a favorable safety profile. Notably, none of the common corticosteroid side effects, such as high blood pressure or hyperglycemia, were observed. Additionally, the data highlighted a positive effect on neurological symptoms in children aged six to nine, a critical group that often experiences rapid clinical decline.
These encouraging results strengthen the basis for Quince’s ongoing pivotal Phase 3 NEAT trial under a U.S. FDA Special Protocol Assessment, as the company continues to pursue effective therapies for A-T.
Read Announcement- Drug:
- EryDex
- Announced Date:
- June 25, 2024
- Indication:
- For the Treatment of Ataxia-Telangiectasia
Announcement
Quince Therapeutics, Inc. announced that the first patient has been dosed in the company's Phase 3 NEAT (Neurologic Effects of EryDex on Subjects with A-T) clinical trial to evaluate the neurological effects of EryDex in patients with Ataxia-Telangiectasia (A-T).
AI Summary
Quince Therapeutics announced that the first patient has been dosed in its Phase 3 NEAT clinical trial. The study is designed to evaluate the neurological effects of EryDex in patients with Ataxia-Telangiectasia (A-T), a rare and severe condition that affects movement and other vital functions in children.
This pivotal trial is international, multi-center, randomized, double-blind, and placebo-controlled. Patients will receive six infusions of EryDex every 21 to 30 days, with the primary endpoint measured by changes in the modified International Cooperative Ataxia Rating Scale. The trial aims to determine whether EryDex can improve neurological symptoms for those living with A-T, addressing an unmet need as no approved treatments currently exist. Topline results are expected in the second half of 2025, with plans for further regulatory submissions if the study yields positive outcomes.
Read Announcement
Quince Therapeutics FDA Events - Frequently Asked Questions
As of now, Quince Therapeutics (QNCX) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Quince Therapeutics (QNCX) has reported FDA regulatory activity for EryDex.
The most recent FDA-related event for Quince Therapeutics occurred on June 25, 2025, involving EryDex. The update was categorized as "Provided Update," with the company reporting: "Quince Therapeutics, Inc announced its participation at the upcoming 2025 A-T Clinical Research Conference organized by the A-T Society, a leading Ataxia-Telangiectasia (A-T) patient advocacy group based in the United Kingdom."
Currently, Quince Therapeutics has one therapy (EryDex) targeting the following condition: For the Treatment of Ataxia-Telangiectasia.
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:QNCX) was last updated on 7/13/2025 by MarketBeat.com Staff
