Shares of UNITY Biotechnology UBX crashed 28.8% yesterday, following mixed results from a mid-stage non-inferiority study of its lead candidate, intravitreal UBX1325 compared with Regeneron’s REGN Eylea (aflibercept) in diabetic macular edema (“DME”) patients.
The primary efficacy endpoint of the phase IIb ASPIRE study is demonstrating non-inferiority to Eylea, measured by mean change in Best Corrected Visual Acuity from baseline to the average of weeks 20 and 24. The study enrolled 52 DME patients with poor vision despite prior anti-VEGF treatment and was randomized equally to receive either 10 μg UBX1325 or 2 mg of REGN’s Eylea. UBX1325 is UNITY Biotechnology’s novel BCL-xL inhibitor with a unique mechanism of action.
UBX’s Phase II ASPIRE Study Results in Detail
The data readout from the mid-stage DME study demonstrated that treatment with the candidate resulted in vision gains, non-inferior to Regeneron’s Eylea, at weeks 24 and 36 in the difficult-to-treat patient population. Patients treated with UBX1325 achieved a +5.2 letter improvement in visual acuity at 24 weeks and a +5.5 letter gain at 36 weeks.
UBX1325 demonstrated statistically significant non-inferiority to Eylea at all time points up to 36 weeks, except for the average of weeks 20 and 24, where it met non-inferiority at an 88% confidence interval, just below the pre-specified 90% threshold for the primary analysis endpoint. This likely caused the stock price to crash.
Year to date, shares of UNITY Biotechnology have rallied 33.1% compared with the industry’s 5.6% growth.
Image Source: Zacks Investment Research
Additionally, UBX reported that DME patients receiving UBX1325 experienced an increase in Central Subfield Thickness (“CST”) at weeks 16 and 20. CST is an objective measurement of macular thickness.
UBX1325 generally performed better than REGN’s Eylea in patients with moderate disease severity, measured as baseline CST less than 400 microns, who made up about 60% of the ASPIRE study population. Patients who transitioned from Eylea to UBX1325 before enrollment showed the most consistent and long-lasting vision improvements.
UBX1325 has consistently shown a favorable safety and tolerability profile across multiple clinical studies, with no reported cases of intraocular inflammation, retinal artery occlusion, endophthalmitis or vasculitis.
UNITY Biotechnology expects to report the complete 36-week data of the remaining patients in the second quarter of 2025.
Eylea is Regeneron’s blockbuster eye disease drug, which is already approved for wet age-related macular degeneration, DME, diabetic retinopathy and retinal vein occlusion. The FDA has also approved REGN’s Eylea to treat preterm infants with retinopathy of prematurity.
UNITY Biotechnology, Inc. Price and Consensus
UNITY Biotechnology, Inc. price-consensus-chart | UNITY Biotechnology, Inc. Quote
UBX’s Zacks Rank and Other Stocks to Consider
UNITY Biotechnology currently carries a Zacks Rank #2 (Buy).
Some other top-ranked stocks from the sector are Gilead Sciences GILD and Dynavax Technologies Corporation DVAX, each carrying a Zacks Rank #2 at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 30 days, Gilead Sciences’ earnings estimate for 2025 has improved from $7.81 to $7.87 per share. During the same timeframe, the estimate for earnings per share for 2026 has improved from $8.11 to $8.27. Year to date, shares of Gilead Sciences have gained 15.6%.
GILD’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 19.47%.
In the past 30 days, estimates for Dynavax’s earnings per share have increased from 32 cents to 33 cents for 2025. During the same time, earnings per share have increased from 49 cents to 57 cents for 2026. Year to date, shares of DVAX have gained 8.4%.
DVAX’s earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 9.58%.
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
Regeneron Pharmaceuticals, Inc. (REGN) : Free Stock Analysis Report
Dynavax Technologies Corporation (DVAX) : Free Stock Analysis Report
Gilead Sciences, Inc. (GILD) : Free Stock Analysis Report
UNITY Biotechnology, Inc. (UBX) : Free Stock Analysis Report
This article originally published on Zacks Investment Research (zacks.com).
Zacks Investment Research
Comments