SPY001 was well tolerated with a favorable safety profile consistent with the anti-α4β7 class SPY001 pharmacokinetics exceeded expectations with a ~4-fold increase relative to vedolizumab, supporting potential Q6M maintenance dosing with a single subcutaneous (SC) injection Planned Phase 2 induction regimen targets drug concentrations in quartile 4 of vedolizumab's exposure-response relationship, which has the potential to increase or accelerate efficacy Single, lowest dose of SPY001 led to complete saturation of α4β7 receptors through Week 12 (longest follow-up available for pharmacodynamic data) Company plans to initiate a platform Phase 2 trial in mid-2025 that will include SPY001, follow

WALTHAM, Mass., Nov. 11, 2024 /PRNewswire/ -- Spyre Therapeutics, Inc. (NASDAQ:SYRE) (the "Company" or "Spyre"), a clinical-stage biotechnology company utilizing best-in-class antibody engineering, rational therapeutic combinations, and precision medicine approaches to target improved efficacy and convenience in the treatment of inflammatory bowel disease ("IBD"), today announced it will report interim results from the Phase 1 SPY001 healthy volunteer trial on Tuesday, November 12, 2024. Following the announcement, the Company will host a conference call and webcast at 8:00am ET to discuss the results. To access the live and archived webcast, please visit the Investor Relations page of Spyre

WALTHAM, Mass., March 7, 2025 /PRNewswire/ -- Spyre Therapeutics, Inc. (NASDAQ:SYRE) (the "Company" or "Spyre"), a clinical-stage biotechnology company utilizing best-in-class antibody engineering, dose optimization and rational therapeutic combinations to target improved efficacy and convenience in the treatment of IBD and other immune-mediated diseases, today announced that Spyre's independent Compensation Committee of the Board of Directors approved the grant of stock options to purchase 132,200 shares of common stock of Spyre to five non-executive employees as equity inducement awards under the Spyre Therapeutics, Inc. 2018 Equity Inducement Plan, as amended (the "2018 Plan"). The stock

Reported positive interim pharmacokinetic ("PK") and safety data in Phase 1 trial of SPY001 in November 2024 and strengthened the balance sheet with a $230 million public offering Continued execution towards expected milestones across portfolio, with interim Phase 1 data readouts for SPY002 and SPY003 on-track for the second quarter and second half of 2025, respectively Remain on track for initiation of Phase 2 platform trial in ulcerative colitis ("UC") in mid-2025 with SPY001 (α4β7), followed by SPY002 (TL1A), SPY003 (IL-23), and combinations thereof, with initial monotherapy results expected in 2026 Announced indication expansion into rheumatoid arthritis ("RA") with SPY002, with expected

WALTHAM, Mass., Feb. 25, 2025 /PRNewswire/ -- 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 that management will participate in the following upcoming investor conferences: Event: TD Cowen 45th Annual Healthcare ConferenceFormat: Fireside chat and 1x1 meetingsDate/Time: Tuesday, March 4, 2025 at 3:10pm ETLocation: Boston, MA Event: Jefferies Biotech on the Beach SummitFormat: 1x1 meetingsDate: Tuesday, March 11, 2025Location: Miami, FL Live audio webca

WALTHAM, Mass., Feb. 19, 2025 /PRNewswire/ -- Spyre Therapeutics, Inc. (NASDAQ:SYRE) (the "Company" or "Spyre"), 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 a poster presentation at the 20th Congress of the European Crohn's and Colitis Organisation (ECCO), held February 19-22, 2025, in Berlin, Germany, showing that combined inhibition of α4β7 integrin and TL1A cytokine is superior to either monotherapy in mouse models of colitis and coadministration demonstrates no drug-drug effects on exp

WALTHAM, Mass., Feb. 7, 2025 /PRNewswire/ -- Spyre Therapeutics, Inc. (NASDAQ:SYRE) (the "Company" or "Spyre"), a clinical-stage biotechnology company utilizing best-in-class antibody engineering, rational therapeutic combinations, and precision medicine approaches to target improved efficacy and convenience in the treatment of IBD and other immune-mediated diseases, today announced that Spyre's independent Compensation Committee of the Board of Directors approved the grant of stock options to purchase 35,000 shares of common stock of Spyre to three non-executive employees as equity inducement awards under the Spyre Therapeutics, Inc. 2018 Equity Inducement Plan, as amended (the "2018 Plan")

Phase 1 interim results expected for SPY002, two distinct extended half-life TL1A antibodies, in 2Q2025 Phase 1 interim results expected for SPY003, an extended half-life IL-23 antibody, in 2H2025 Phase 2 platform trial in ulcerative colitis (UC) remains on track for initiation in mid-2025 with SPY001 (α4β7), followed by SPY002 (TL1A), SPY003 (IL-23), and combinations thereof, with initial results expected in 2026 Announces indication expansion into rheumatoid arthritis (RA) with SPY002; Phase 2 RA trial initiation anticipated in mid-2025 with topline results in 2026 Strong balance sheet with preliminary cash, cash equivalents, and marketable securities balance of over $600M as of December

WALTHAM, Mass., Jan. 3, 2025 /PRNewswire/ -- Spyre Therapeutics, Inc. (NASDAQ:SYRE) (the "Company" or "Spyre"), a clinical-stage biotechnology company utilizing best-in-class antibody engineering, rational therapeutic combinations, and precision medicine approaches to target improved efficacy and convenience in the treatment of Inflammatory Bowel Disease ("IBD"), today announced that Spyre's independent Compensation Committee of the Board of Directors approved the grant of stock options to purchase 21,000 shares of common stock of Spyre to one non-executive employee as an equity inducement award under the Spyre Therapeutics, Inc. 2018 Equity Inducement Plan, as amended (the "2018 Plan"). The

WALTHAM, Mass., Dec. 18, 2024 /PRNewswire/ -- Spyre Therapeutics, Inc. (NASDAQ:SYRE), a clinical-stage biotechnology company utilizing best-in-class antibody engineering, rational therapeutic combinations, and precision medicine approaches to target improved efficacy and convenience in the treatment of Inflammatory Bowel Disease ("IBD"), today announced Spyre has been added to the Nasdaq Biotechnology Index (NASDAQ:NBI), effective prior to market open, Monday, December 23, 2024. The NBI is designed to track the performance of a set of securities listed on The Nasdaq Stock Market® that are classified as either biotechnology or pharmaceutical according to the Industry Classification Benchmark.

WALTHAM, Mass., Dec. 2, 2024 /PRNewswire/ -- Spyre Therapeutics, Inc. (NASDAQ:SYRE) (the "Company" or "Spyre"), a clinical-stage biotechnology company utilizing best-in-class antibody engineering, rational therapeutic combinations, and precision medicine approaches to target improved efficacy and convenience in the treatment of Inflammatory Bowel Disease ("IBD"), today announced that Spyre's independent Compensation Committee of the Board of Directors approved the grant of stock options to purchase an aggregate of 45,000 shares of common stock of Spyre to three non-executive employees as equity inducement awards under the Spyre Therapeutics, Inc. 2018 Equity Inducement Plan, as amended (the

Spyre is concurrently advancing two anti-TL1A molecules into first-in-human studies Preclinical data for both SPY002 molecules demonstrate picomolar potency and potential for quarterly or twice-yearly dosing, suggesting opportunity for improved efficacy and convenience over first-generation anti-TL1As which are dosed every two to four weeks Interim pharmacokinetic, pharmacodynamic, and safety data from healthy volunteers for both SPY002 molecules anticipated in the second quarter of 2025 Spyre expects to introduce SPY002 to its planned Phase 2 study in ulcerative colitis exploring quarterly monotherapies and combinations; the Company also intends to initiate a proof-of-concept Phase 2 study

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Wedbush initiated coverage of Spyre Therapeutics with a rating of Outperform and set a new price target of $45.00

Evercore ISI initiated coverage of Spyre Therapeutics with a rating of Outperform

Robert W. Baird initiated coverage of Spyre Therapeutics with a rating of Outperform and set a new price target of $50.00

Wells Fargo upgraded Spyre Therapeutics from Equal Weight to Overweight and set a new price target of $35.00 from $12.00 previously

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Continued execution towards expected milestones across portfolio, with SPY001 on-track for interim Phase 1 data by year-end 2024, and SPY002 on-track for initiation of first-in-human trials in the fourth quarter of 2024 Presented new data on SPY003, a potential best-in-class half-life extended anti-IL-23 antibody, demonstrating robust preclinical potency and a greater than three-fold increase in non-human primate half-life compared to risankizumab  Accelerated expected initiation of first-in-human trial for SPY003 to the first quarter of 2025 $414 million of cash, cash equivalents, and marketable securities as of September 30, 2024, with expected runway well into 2027, through multiple clini

WALTHAM, Mass., Oct. 1, 2024 /PRNewswire/ -- Spyre Therapeutics, Inc. (NASDAQ:SYRE) (the "Company" or "Spyre"), a clinical-stage biotechnology company utilizing best-in-class antibody engineering, rational therapeutic combinations, and precision medicine approaches to target improved efficacy and convenience in the treatment of inflammatory bowel disease ("IBD"), today announced the appointment of Sheldon Sloan, M.D., M. Bioethics, as Chief Medical Officer. Dr. Sloan brings more than 25 years of experience in both large pharmaceutical and small biotech companies with an extensive track record of program leadership in the field of Inflammation and Immunology. This includes more than 15 years

Initiated dosing in Phase 1 trial of SPY001, an anti-α4β7 antibody engineered for infrequent, subcutaneous maintenance dosing, with interim proof-of-concept data on track for year-end 2024 SPY002, an anti-TL1A antibody program designed for enhanced potency to both TL1A monomers and trimers, and extended half-life compared to existing molecules, remains on track to begin first-in-human trials in the second half of 2024 Nominated a development candidate for SPY003, a highly potent anti-IL-23 antibody with an extended half-life compared to existing molecules, with expectations to begin a first-in-human trial in the first half of 2025 $426 million of cash, cash equivalents, marketable securities

WALTHAM, Mass., May 15, 2024 /PRNewswire/ -- Spyre Therapeutics, Inc. (NASDAQ:SYRE) (the "Company" or "Spyre"), a development-stage biotechnology company advancing best-in-class antibody engineering, rational therapeutic combinations, and precision medicine approaches for the treatment of Inflammatory Bowel Disease ("IBD"), today announced the appointment of Sandra Milligan, M.D., J.D., President of Aspira Women's Health, to its Board of Directors. "With a distinguished career spanning leadership roles at large and small biopharmaceutical companies, Dr. Milligan brings deep expertise in clinical development and regulatory affairs, including within IBD, that will be invaluable as we execute o

SPY001, an anti-α4β7 antibody engineered for infrequent, subcutaneous dosing successfully completed a 28-day GLP toxicity study and remains on track to begin first-in-human studies in the second quarter of 2024, with interim proof-of-concept data expected year-end 2024 SPY002, an anti-TL1A antibody designed for enhanced potency to both TL1A monomers and trimers, and extended half-life compared to existing molecules, remains on track to begin first-in-human studies in the second half of 2024 Raised $180 million in a March 2024 private placement equity financing with participation from new and existing investors $485 million of cash, cash equivalents, marketable securities, and restricted cash

Announced corporate name change to Spyre Therapeutics; appointment of Cameron Turtle, DPhil, as Chief Executive Officer; and began trading on Nasdaq under the symbol "SYRE" SPY001, an anti-α4β7 antibody engineered for infrequent, subcutaneous dosing, demonstrated an updated half-life of 22 days, a greater than three-fold increase relative to vedolizumab in non-human primate pharmacokinetic data recently presented at ECCO; remains on track to begin first-in-human studies in the first half of 2024, with interim proof-of-concept data expected year-end 2024 SPY002, an anti-TL1A antibody designed for enhanced potency to both TL1A monomers and trimers, and extended half-life compared to existing m

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