Shares of Spyre Therapeutics SYRE have surged 73% over the past month after the company reported encouraging data from a mid-stage study evaluating its investigational anti-α4β7 drug, SPY001, in patients with moderate-to-severe ulcerative colitis (UC).
The drug met the primary endpoint, delivering a statistically significant 9.2-point reduction in the Robarts Histopathology Index (RHI) — a key measure of tissue-level inflammation in UC — after 12 weeks of treatment. Data from the study showed that treatment with the drug achieved a 40% clinical remission rate and a 51% endoscopic improvement rate.
In addition to strong efficacy, SPY001 demonstrated a favorable safety profile that was consistent with the α4β7 class. Spyre reported that six participants experienced treatment-emergent adverse events, including one serious adverse event that was not considered drug-related. The most common side-effect was back pain.
These results come from Part A of the SKYLINE study, which is evaluating Spyre’s anti-TL1A antibody SPY002 and anti-IL-23 antibody SPY003. While Part A is an open-label phase assessing each drug individually, Part B will be a randomized, placebo-controlled stage evaluating different doses and combinations of these therapies.
Initial data from the SPY002 and SPY003 cohorts in Part A of the SKYLINE study are expected in mid-2026 and the third quarter of 2026, respectively.
What Makes SYRE’s Results So Special?
SPY001 targets the same α4β7 integrin pathway as Takeda Pharmaceutical’s TAK blockbuster drug Entyvio (vedolizumab), a well-established therapy in UC. Spyre has designed its drug with an extended half-life and optimized dosing, which may enable higher drug exposure and potentially less frequent maintenance dosing than the TAK drug, improving both efficacy and patient convenience.
This differentiated profile likely contributed to the recent surge in SYRE shares. Year to date, the stock has rallied 123% compared with the industry’s 1% growth.
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The company highlighted that SPY001’s efficacy compares favorably not only within the α4β7 class but against therapies across other mechanisms. In a conference call, management claimed that the efficacy data reported in the SKYLINE study were higher than those reported for either combination component in Johnson & Johnson’s JNJ mid-stage VEGA study.
This J&J study evaluated the IL-23 inhibitor Tremfya (guselkumab) and anti-TNF therapy Simponi (golimumab) as induction therapy in UC patients, aiming to improve outcomes by targeting multiple inflammatory pathways simultaneously.
Spyre Therapeutics, Inc. Price
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SYRE’s Zacks Rank
Spyre currently has a Zacks Rank #4 (Sell).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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