FDA Events for UNITY Biotechnology (UBX)
This section highlights FDA-related milestones and regulatory updates for drugs developed by UNITY Biotechnology (UBX).
Over the past two years, UNITY Biotechnology has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
UBX1325. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
UBX1325 - FDA Regulatory Timeline and Events
UBX1325 is a drug developed by UNITY Biotechnology for the following indication: Diabetic Retinopathy Eye Diseases.
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:
- UBX1325
- Announced Date:
- May 5, 2025
- Indication:
- Diabetic Retinopathy Eye Diseases
Announcement
UNITY Biotechnology, Inc announced complete 36-week results from the Phase 2b ASPIRE clinical trial of intravitreal UBX1325 in patients with diabetic macular edema (DME) who had poor vision despite prior anti-VEGF treatment.
AI Summary
UNITY Biotechnology, Inc. announced the 36-week results of its Phase 2b ASPIRE trial studying UBX1325, an investigational treatment for diabetic macular edema (DME) in patients with poor vision despite previous anti-VEGF therapies. The study demonstrated that UBX1325 achieved vision improvements that were non-inferior to those seen with aflibercept at the 36-week mark.
Importantly, results showed that UBX1325 generally outperformed aflibercept in a subgroup of patients with central subfield thickness below 400 microns, making up about 60% of the study participants. The favorable safety and tolerability profile observed adds promise for UBX1325 to be an alternative option for DME treatment through a novel mechanism of action, potentially benefiting patients who do not respond well to existing therapies.
Read Announcement- Drug:
- UBX1325
- Announced Date:
- April 23, 2025
- Indication:
- Diabetic Retinopathy Eye Diseases
Announcement
UNITY Biotechnology, Inc. announced that the peer-reviewed journal NEJM Evidence published results from the Phase 2 BEHOLD study of UBX1325 in patients with diabetic macular edema (DME).
AI Summary
UNITY Biotechnology, Inc. announced that the peer-reviewed journal NEJM Evidence published the results of the Phase 2 BEHOLD study of UBX1325 in patients with diabetic macular edema (DME). The study showed that a single 10 mcg injection of UBX1325 led to significant and lasting improvements in vision over a 48-week period. By selectively clearing senescent cells in the retina, UBX1325 appears to remodel the retinal vasculature and address the underlying inflammation that drives DME. This approach not only improved visual acuity but also demonstrated the potential for a sustained therapeutic benefit after just one treatment. The promising results support UBX1325 as a novel modality for treating retinal diseases, paving the way for further clinical trials and future treatments for patients suffering from DME.
Read Announcement- Drug:
- UBX1325
- Announced Date:
- March 23, 2025
- Estimated Event Date Range:
- March 24, 2025 - March 24, 2025
- Target Action Date:
- March 24, 2025
- Indication:
- Diabetic Retinopathy Eye Diseases
Announcement
UNITY Biotechnology to Host Virtual Investor Event to Discuss 24- and 36-Week Data from the Phase 2b ASPIRE Study of UBX1325 in Patients with Diabetic Macular Edema (DME) on March 24, 2025
AI Summary
UNITY Biotechnology will host a virtual investor event on March 24, 2025, at 8:00 AM ET to discuss important findings from the Phase 2b ASPIRE study. The event will focus on the 24- and 36-week results for UBX1325, an investigational compound being studied for diabetic macular edema (DME). UBX1325 is designed to work as a senolytic, targeting proteins that help senescent cells survive, which may offer improved long-term visual outcomes for patients. Renowned ophthalmology expert Dr. Robert Bhisitkul from UCSF will join company management during the presentation, reviewing the study data on the safety and efficacy of UBX1325 in DME patients.
Following the presentation, there will be a live question and answer session. This event provides an opportunity for investors to gain detailed insights into the potential of UBX1325 as a new treatment in retinal diseases.
Read Announcement- Drug:
- UBX1325
- Announced Date:
- April 23, 2024
- Indication:
- Diabetic Retinopathy Eye Diseases
Announcement
UNITY Biotechnology announced that the ongoing Phase 2b ASPIRE study of UBX1325 has been extended from 24 to 36 weeks to assess potentially greater durability compared to aflibercept.
AI Summary
UNITY Biotechnology has extended its Phase 2b ASPIRE study of UBX1325 from 24 weeks to 36 weeks. This move is designed to evaluate whether UBX1325 offers greater durability than aflibercept in treating diabetic macular edema (DME). The study’s extension allows researchers to assess the long-term benefits of UBX1325, which targets senescent cells, a novel approach in DME treatment. Additionally, the patient group is being increased from 40 to 50 participants to improve the study’s statistical power, ensuring more reliable results. The ASPIRE study will compare changes in visual acuity between UBX1325 and aflibercept and includes a period between weeks 24 and 36 without scheduled treatments to directly compare the durability of each treatment. Topline data will be presented in two readouts in 2025, making this study a key part of evaluating the potential benefits of UBX1325 over standard care.
Read Announcement
UNITY Biotechnology FDA Events - Frequently Asked Questions
As of now, UNITY Biotechnology (UBX) has not received any FDA approvals for its therapy in the last two years.
In the past two years, UNITY Biotechnology (UBX) has reported FDA regulatory activity for UBX1325.
The most recent FDA-related event for UNITY Biotechnology occurred on May 5, 2025, involving UBX1325. The update was categorized as "Results," with the company reporting: "UNITY Biotechnology, Inc announced complete 36-week results from the Phase 2b ASPIRE clinical trial of intravitreal UBX1325 in patients with diabetic macular edema (DME) who had poor vision despite prior anti-VEGF treatment."
Currently, UNITY Biotechnology has one therapy (UBX1325) targeting the following condition: Diabetic Retinopathy Eye Diseases.
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:UBX) was last updated on 7/12/2025 by MarketBeat.com Staff
