Spyre Therapeutics presents promising Phase 1 data for SPY002 in IBD at UEGW Congress, highlighting safety and dosing advantages.
Quiver AI Summary
Spyre Therapeutics, Inc., a biotechnology company specializing in treatments for Inflammatory Bowel Disease (IBD) and other immune-related conditions, announced new scientific findings at the UEGW Congress regarding their investigational drug SPY002. Preliminary results from a Phase 1 study show that SPY002, a novel anti-TL1A agent, is well tolerated and supports extended dosing intervals, potentially allowing for quarterly or biannual administration. Additionally, preclinical data for combination therapies involving different agents demonstrated improved efficacy in mouse models compared to single therapies, which supports the company's ongoing Phase 2 SKYLINE-UC study. The findings emphasize Spyre's commitment to innovative treatments for IBD and will be presented during the Congress.
Potential Positives
- Spyre Therapeutics presented promising follow-up data from its Phase 1 study of SPY002, indicating it is well tolerated and supports a potentially convenient dosing schedule of either quarterly or twice-yearly regimens.
- The company reported new preclinical data showing that its combination therapies demonstrate superior efficacy compared to monotherapy, which may enhance the potential effectiveness of their pipeline products.
- The ongoing SKYLINE-UC Phase 2 study provides further validation for Spyre's innovative approach to treating Inflammatory Bowel Disease, suggesting a strong pipeline for future therapies.
Potential Negatives
- Press release heavily relies on forward-looking statements, indicating uncertainty and potential risks related to the efficacy and safety profile of their product SPY002, which may affect investor confidence.
- Company acknowledges that there may be consistency issues between interim data and final data, which could reflect poorly on the reliability of their results.
- Mentions potential regulatory disagreements could impact clinical trial processes, introducing further risks to the development timeline of their product candidates.
FAQ
What is Spyre Therapeutics known for?
Spyre Therapeutics is a biotechnology company focused on antibody engineering and treatments for Inflammatory Bowel Disease (IBD) and immune-mediated diseases.
What results were presented at the UEGW Congress?
The results from a Phase 1 study of SPY002 indicate it is well tolerated and supports potential quarterly or semi-annual dosing.
What is the significance of SPY002?
SPY002 is a candidate for becoming a best-in-class therapy for IBD, showing promise in efficacy and dosing convenience.
What combination therapies were discussed in the findings?
The study highlighted combination programs of α4β7 + TL1A, α4β7 + IL-23, and TL1A + IL-23 demonstrating superior efficacy in preclinical models.
Who can I contact for more information about Spyre Therapeutics?
For investor inquiries, contact Eric McIntyre at Spyre Therapeutics. For media inquiries, reach out to Josie Butler at 1AB.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$SYRE Insider Trading Activity
$SYRE insiders have traded $SYRE stock on the open market 1 times in the past 6 months. Of those trades, 0 have been purchases and 1 have been sales.
Here’s a breakdown of recent trading of $SYRE stock by insiders over the last 6 months:
- SCOTT L BURROWS (Chief Financial Officer) sold 18,428 shares for an estimated $299,639
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$SYRE Hedge Fund Activity
We have seen 80 institutional investors add shares of $SYRE stock to their portfolio, and 42 decrease their positions in their most recent quarter.
Here are some of the largest recent moves:
- TANG CAPITAL MANAGEMENT LLC added 1,150,000 shares (+56.1%) to their portfolio in Q2 2025, for an estimated $17,215,500
- JANUS HENDERSON GROUP PLC removed 1,028,410 shares (-98.8%) from their portfolio in Q2 2025, for an estimated $15,395,297
- PERCEPTIVE ADVISORS LLC removed 783,827 shares (-33.9%) from their portfolio in Q2 2025, for an estimated $11,733,890
- PRICE T ROWE ASSOCIATES INC /MD/ added 681,939 shares (+274.4%) to their portfolio in Q2 2025, for an estimated $10,208,626
- DRIEHAUS CAPITAL MANAGEMENT LLC removed 631,722 shares (-23.2%) from their portfolio in Q2 2025, for an estimated $9,456,878
- BAKER BROS. ADVISORS LP added 626,703 shares (+inf%) to their portfolio in Q2 2025, for an estimated $9,381,743
- DEERFIELD MANAGEMENT COMPANY, L.P. added 613,665 shares (+inf%) to their portfolio in Q2 2025, for an estimated $9,186,565
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$SYRE Analyst Ratings
Wall Street analysts have issued reports on $SYRE in the last several months. We have seen 1 firms issue buy ratings on the stock, and 0 firms issue sell ratings.
Here are some recent analyst ratings:
- Deutsche Bank issued a "Buy" rating on 09/26/2025
To track analyst ratings and price targets for $SYRE, check out Quiver Quantitative's $SYRE forecast page.
$SYRE Price Targets
Multiple analysts have issued price targets for $SYRE recently. We have seen 2 analysts offer price targets for $SYRE in the last 6 months, with a median target of $56.5.
Here are some recent targets:
- David Hoang from Deutsche Bank set a target price of $43.0 on 09/26/2025
- Julian Harrison from BTIG set a target price of $70.0 on 09/16/2025
Full Release
WALTHAM, Mass., Oct. 05, 2025 (GLOBE NEWSWIRE) -- Spyre Therapeutics, Inc. (NASDAQ: SYRE), a clinical-stage biotechnology company advancing best-in-class antibody engineering, dose optimization, and rational therapeutic combinations for the treatment of Inflammatory Bowel Disease (“IBD”) and other immune-mediated diseases, today announced scientific presentations at the UEGW Congress.
“We are excited to share follow-up data out to six months from our Phase 1 study of SPY002, our potential best-in-class anti-TL1A agent in development for IBD. The data continue to show SPY002 is well tolerated, has a differentiated PK profile supporting quarterly or twice-yearly dosing, and suppresses free TL1A through 24 weeks,” said Josh Friedman, M.D., Ph.D., SVP of Clinical Development at Spyre. “Additionally, we are pleased to share new preclinical data demonstrating that each of our combination programs (α4β7 + TL1A, α4β7 + IL-23, and TL1A + IL-23) exhibit superior efficacy relative to constituent monotherapies in rodent TNBS-induced colitis models, providing additional validation for our ongoing SKYLINE-UC Phase 2 study.”
The poster will be available for viewing during the UEGW Congress, and details are as follows:
Title
: Interim Phase 1 Results for SPY002, a Novel Half-Life Extended Monoclonal Antibody Targeting TL1A, Suggests a Potential for Q3M or Q6M Maintenance Dosing for Inflammatory Bowel Disease
Authors
: Y. Vugmeyster, S. Sloan, JD Lu, K. Hew, P. Patel, C. Sheldon, D. Nguyen, R. McLean, M. Huyghe, B. Connolly, B. Wang, M. Kennedy, M. Rose, E. Svejnoha, J. Friedman
Title
: Combined Inhibition of Integrin β7 and TL1A, Integrin β7 and IL-23, or TL1A and IL-23 Are Superior to Their Constituent Monotherapies in Mouse TNBS-Induced Colitis
Authors
: M. Siegel, J. Friedman, E. Lewis, D. Giles, A. Spencer
Full session details can be accessed via the UEGW program.
About Spyre Therapeutics
Spyre Therapeutics is a clinical-stage biotechnology company that aims to create next-generation inflammatory bowel disease (IBD) and other immune-mediated disease products by combining best-in-class antibody engineering, dose optimization, and rational therapeutic combinations. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23.
For more information, please visit http://spyre.com .
Forward-Looking Statements
Certain statements in this press release, other than purely historical information, may constitute "forward-looking statements" within the meaning of the federal securities laws, including for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995, concerning Spyre and other matters. These forward-looking statements include, but are not limited to, express or implied statements relating to Spyre's management team's expectations, hopes, beliefs, intentions or strategies regarding the future including, without limitation, Spyre’s ability to achieve the expected benefits or opportunities with respect to its pipeline of product candidates such as the potential efficacy, tolerability, convenience, commercial viability, dosing regimen and safety profile of SPY002 in humans, including the potential for a quarterly or twice yearly dosing profile; the potential for SPY002 to become a best-in-class therapy for IBD; the potential consistency of the SPY002 Phase 2 trial final data readouts with interim Phase 1 results; and the potential therapeutic benefits of Spyre’s product candidates as monotherapies or in combinations and their extended half-life, including the expected duration of half-life in comparison to competitor products and the potential potency, efficacy and convenience compared to today’s standard of care. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words "opportunity," "potential," "milestones," "pipeline," "can," "goal," "aim," "strategy," "target," "seek," "anticipate," "achieve," "believe," "contemplate," "continue," "could," "estimate," "expect," "intends," "may," "might," "plan," "possible," "predict," "project," "should," "will," "would," and similar expressions (including the negatives of these terms or variations of them) may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements are based on current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting Spyre will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond Spyre's control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited, uncertainties and risks arising from regulatory feedback, including potential disagreement by regulatory authorities with the Company’s interpretation of data and the Company’s clinical trials for its product candidates, including our plans for and timing of cohort initiation for combination therapy arms for the ongoing SKYLINE-UC Phase 2 platform trial across different jurisdictions; the potential for final data not being consistent with or different than the interim data reported for our programs; the potential impact of Trump Administration policies and changes in law on our business; and those uncertainties and factors described under the heading "Risk Factors," "Risk Factor Summary" and "Note about Forward-Looking Statements" in Spyre's most recent Annual Report on Form 10-K, as supplemented and updated by subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K that the Company has filed or will file with the SEC, as well as discussions of potential risks, uncertainties, and other important factors included in other filings by Spyre from time to time. Should one or more of these risks or uncertainties materialize, or should any of Spyre's assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth therein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements in this press release, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. Spyre does not undertake or accept any duty to make any updates or revisions to any forward-looking statements. This press release does not purport to summarize all of the conditions, risks and other attributes of an investment in Spyre.
For Investors:
Eric McIntyre
VP of Finance and Investor Relations
Spyre Therapeutics
[email protected]
For Media:
Josie Butler, 1AB
[email protected]