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Spyre's Anti-IL-23 Antibody Meets Goal in Ulcerative Colitis Study
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Key Takeaways
SPY003 reduced RHI by 10.0 points and achieved 20% clinical remission in phase II UC.
Spyre's all three inflammatory bowel diseases mechanisms posted positive part A results.
Part B is enrolling patients, with top-line induction data expected in 2027 as the next major catalyst.
Spyre Therapeutics (SYRE - Free Report) announced positive top-line induction data from a mid-stage study evaluating its investigational anti-IL-23 drug, SPY003, in patients with moderate-to-severe ulcerative colitis (UC).
Key Highlights of SYRE’s Phase II SKYLINE SPY003 Study
Spyre evaluated SPY003 as monotherapy in part A of the phase II SKYLINE platform study for the UC indication. The study met its primary endpoint by demonstrating that SPY003 produced a statistically significant 10.0-point reduction from baseline in Robarts Histopathology Index (RHI), a key measure of tissue-level inflammation in UC, after 12 weeks of treatment. The therapy achieved a 20% clinical remission rate and a 30% endoscopic improvement rate, providing clinical proof-of-concept for the candidate.
In addition to strong efficacy, SPY003 showed a favorable safety profile that was consistent with the IL-23 class.
Year to date, the stock has rallied 177.2% compared with the industry’s 10.2% growth.
Image Source: Zacks Investment Research
Positive Results Across SYRE’s All 3 IBD Mechanisms
The SPY003 results were particularly important because they completed positive part A readouts of the SKYLINE study for all three mechanisms in Spyre's inflammatory bowel diseases (IBD) portfolio: α4β7, TL1A and IL-23.
Earlier in 2026, Spyre reported positive induction data for SPY001, its investigational anti-α4β7 antibody and SPY002, its anti-TL1A antibody in UC. Both candidates met their primary endpoint.
Spyre noted that the 10.0-point RHI improvement for SPY003 was broadly comparable with the 9.2-point reduction for SPY001 and 10.7-point reduction for SPY002 in patients with moderately to severely active UC, supporting the company’s strategy of developing multiple optimized mechanisms for combination treatment in IBD.
SKYLINE Part B: Next Major Catalyst
The SKYLINE phase II platform study is evaluating SPY001, SPY002 and SPY003 both as monotherapies and in pairwise combinations in patients with moderately to severely active UC.
While part A is an open-label stage designed to evaluate the individual candidates, part B is a randomized, placebo-controlled stage that will assess different doses and combinations of these therapies. With positive part A results reported, the focus now shifts toward the part B program. Part B of the study is currently enrolling patients, with top-line induction data expected in 2027. Positive data could be an important catalyst for Spyre’s IBD portfolio.
Over the past 60 days, estimates for Precigen’s 2026 bottom line have improved from a loss of 2 cents to earnings per share of 25 cents. Over the same period, earnings estimates for 2027 have risen from 25 cents to 86 cents. PGEN shares have increased 64.4% year to date.
Precigen’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 108.96%.
Over the past 60 days, estimates for AC Immune’s 2026 loss per share have narrowed from 84 cents to 60 cents. Over the same period, earnings estimates for 2027 remained unchanged at 17 cents. ACIU shares have lost 11.5% year to date.
AC Immune’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 33.25%.
Over the past 60 days, loss per share estimates for Aldeyra Therapeuticshave narrowed from 43 cents to 39 cents for 2026. Over the same period, estimates for 2027 loss per share have narrowed from 22 cents to 16 cents. ALDX shares have plunged 70.3% year to date.
Aldeyra Therapeutics’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 29.25%.
View the Zacks #1 Rank List
Image: Bigstock
Spyre's Anti-IL-23 Antibody Meets Goal in Ulcerative Colitis Study
Key Takeaways
Spyre Therapeutics (SYRE - Free Report) announced positive top-line induction data from a mid-stage study evaluating its investigational anti-IL-23 drug, SPY003, in patients with moderate-to-severe ulcerative colitis (UC).
Key Highlights of SYRE’s Phase II SKYLINE SPY003 Study
Spyre evaluated SPY003 as monotherapy in part A of the phase II SKYLINE platform study for the UC indication. The study met its primary endpoint by demonstrating that SPY003 produced a statistically significant 10.0-point reduction from baseline in Robarts Histopathology Index (RHI), a key measure of tissue-level inflammation in UC, after 12 weeks of treatment. The therapy achieved a 20% clinical remission rate and a 30% endoscopic improvement rate, providing clinical proof-of-concept for the candidate.
In addition to strong efficacy, SPY003 showed a favorable safety profile that was consistent with the IL-23 class.
Year to date, the stock has rallied 177.2% compared with the industry’s 10.2% growth.
Image Source: Zacks Investment Research
Positive Results Across SYRE’s All 3 IBD Mechanisms
The SPY003 results were particularly important because they completed positive part A readouts of the SKYLINE study for all three mechanisms in Spyre's inflammatory bowel diseases (IBD) portfolio: α4β7, TL1A and IL-23.
Earlier in 2026, Spyre reported positive induction data for SPY001, its investigational anti-α4β7 antibody and SPY002, its anti-TL1A antibody in UC. Both candidates met their primary endpoint.
Spyre noted that the 10.0-point RHI improvement for SPY003 was broadly comparable with the 9.2-point reduction for SPY001 and 10.7-point reduction for SPY002 in patients with moderately to severely active UC, supporting the company’s strategy of developing multiple optimized mechanisms for combination treatment in IBD.
SKYLINE Part B: Next Major Catalyst
The SKYLINE phase II platform study is evaluating SPY001, SPY002 and SPY003 both as monotherapies and in pairwise combinations in patients with moderately to severely active UC.
While part A is an open-label stage designed to evaluate the individual candidates, part B is a randomized, placebo-controlled stage that will assess different doses and combinations of these therapies. With positive part A results reported, the focus now shifts toward the part B program. Part B of the study is currently enrolling patients, with top-line induction data expected in 2027. Positive data could be an important catalyst for Spyre’s IBD portfolio.
SYRE’s Zacks Rank & Stocks to Consider
Spyre currently has a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Precigen (PGEN - Free Report) , currently sporting a Zacks Rank #1 (Strong Buy), and AC Immune (ACIU - Free Report) and Aldeyra Therapeutics (ALDX - Free Report) , carrying a Zacks Rank #2 (Buy) each. You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Precigen’s 2026 bottom line have improved from a loss of 2 cents to earnings per share of 25 cents. Over the same period, earnings estimates for 2027 have risen from 25 cents to 86 cents. PGEN shares have increased 64.4% year to date.
Precigen’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 108.96%.
Over the past 60 days, estimates for AC Immune’s 2026 loss per share have narrowed from 84 cents to 60 cents. Over the same period, earnings estimates for 2027 remained unchanged at 17 cents. ACIU shares have lost 11.5% year to date.
AC Immune’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 33.25%.
Over the past 60 days, loss per share estimates for Aldeyra Therapeuticshave narrowed from 43 cents to 39 cents for 2026. Over the same period, estimates for 2027 loss per share have narrowed from 22 cents to 16 cents. ALDX shares have plunged 70.3% year to date.
Aldeyra Therapeutics’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 29.25%.