공시 • Jun 15

Spyre Therapeutics, Inc. Announces Positive Initial 12-Week Induction Topline Data from Part A of Phase 2 SKYLINE Trial of SPY002 for Treatment Of Moderately-to-Severely Active Ulcerative Colitis

Spyre Therapeutics, Inc. announced positive initial 12-week induction topline data from Part A of the Phase 2 SKYLINE trial of SPY002 for the treatment of moderately-to-severely active ulcerative colitis. SPY002 met its primary endpoint with a statistically significant reduction of 10.7 points (p<0.0001) from baseline at Week 12 in Robarts Histopathology Index (RHI) score. Secondary endpoints included clinical remission by modified Mayo Score of 33% and endoscopic improvement of 42%. SPY002 was well tolerated with a safety profile consistent with the TL1A class. Initial 12-week findings from SKYLINE Part A demonstrated that SPY002 met all key objectives. The study population consisted of 35% advanced therapy-exposed participants with a mean disease duration of 7.0 years, a mean baseline Robarts Histopathology Index (RHI) score of 16.9 8.5 (SD), a mean modified Mayo Score (mMS) of 6.9 1.0 (SD), and 56% of whom had a baseline endoscopy score of 3. SPY002 achieved the primary endpoint, demonstrating a statistically significant 10.7-point reduction in RHI score (p<0.0001), robust rates of clinical remission and endoscopic improvement, and a meaningful change in mMS, results that are among the highest reported in ulcerative colitis. Endpoint (Week 12): SPY002. Change in RHI from baseline: -10.7. Primary endpoint: (p<0.0001). Clinical remission rate: 33%. Endoscopic improvement rate: 42%. Change in modified Mayo Score: -3.7. SPY002 was well tolerated with a safety profile consistent with the TL1A class. There were twenty subjects with treatment-emergent adverse events (TEAEs) during the induction treatment period. Two serious adverse events (SAEs) were reported, both deemed not drug-related. One case was for hospitalization for exacerbation of ulcerative colitis, the other case was for worsening of heart failure in a subject with a history of heart failure. The most common adverse events (AEs) (occurring in 2 patients) were arthralgia (n=2), hypertension (n=3), nausea (n=2), ulcerative colitis (n=2), and viral respiratory tract infection (n=2). SPY002 (n=48): Subjects with any AE (n, %): 20 (41.7%). Severe (Grade 3) AE: 2 (4.2%)1,2. Drug-related AE: 3 (6.3%)3. AE leading to drug discontinuation: 2 (4.2%)2,4. SAE: 2 (4.2%)1,2. Drug-related SAE: 0. AEs of special interest: 0. Death: 0. 1Hospitalization for exacerbation of ulcerative colitis in one subject, deemed not drug-related. 2Hospitalization for worsening heart failure in one subject with history of heart failure and atrial fibrillation, who was subsequently diagnosed with worsening of aortic stenosis; deemed not drug-related. 3One case each of nausea, hypertension, and arthralgia. 4Exacerbation of ulcerative colitis, deemed not drug-related. SKYLINE is a two-part induction and maintenance platform trial of SPY001, SPY002, SPY003, as well as pairwise combinations thereof (six investigational agents total) in patients with moderately-to-severely active ulcerative colitis. Part A is an open-label assessment of the safety and efficacy of a single dose level of each investigational monotherapy, and Part B is a randomized and placebo-controlled assessment of the safety and efficacy of investigational monotherapies (two dose levels) and combinations. SPY002 is an extended half-life investigational antibody targeting TL1A, an upstream cytokine implicated in chronic inflammation and fibrosis in inflammatory bowel disease. Initial 12-week findings from SKYLINE Part A demonstrated that SPY002 met all key objectives. The study population consisted of 35% advanced therapy-exposed participants with a mean disease duration of 7.0 years, a mean baseline RHI score of 16.9 8.5 (SD), a mean modified Mayo Score of 6.9 1.0 (SD), and 56% of whom had a baseline endoscopy score of 3. Efficacy: SPY002 achieved the primary endpoint, demonstrating a statistically significant 10.7-point reduction in RHI score (p<0.0001), robust rates of clinical remission and endoscopic improvement, and a meaningful change in mMS, results that are among the highest reported in ulcerative colitis. Endpoint (Week 12): SPY002. Change in RHI from baseline: -10.7. Primary endpoint: (p<0.0001). Clinical remission rate: 33%. Endoscopic improvement rate: 42%. Change in modified Mayo Score: -3.7. Safety: SPY002 was well tolerated with a safety profile consistent with the TL1A class. There were twenty subjects with treatment-emergent adverse events (TEAEs) during the induction treatment period. Two serious adverse events (SAEs) were reported, both deemed not drug-related. One case was for hospitalization for exacerbation of ulcerative colitis, the other case was for worsening of heart failure in a subject with a history of heart failure. The most common adverse events (AEs) (occurring in 2 patients) were arthralgia (n=2), hypertension (n=3), nausea (n=2), ulcerative colitis (n=2), and viral respiratory tract infection (n=2). SPY002 (n=48): Subjects with any AE (n, %): 20 (41.7%). Severe (Grade 3) AE: 2 (4.2%)1,2. Drug-related AE: 3 (6.3%)3. AE leading to drug discontinuation: 2 (4.2%)2,4. SAE: 2 (4.2%)1,2. Drug-related SAE: 0. AEs of special interest: 0. Death: 0. 1Hospitalization for exacerbation of ulcerative colitis in one subject, deemed not drug-related. 2Hospitalization for worsening heart failure in one subject with history of heart failure and atrial fibrillation, who was subsequently diagnosed with worsening of aortic stenosis deemed not drug-related. 3One case each of nausea, hypertension, and arthralgia. 4Exacerbation of ulcerative colitis, deemed not drug-related.

공시 • Nov 12

Spyre Therapeutics, Inc. Announces Positive Interim Phase 1 Data from its First-In-Human Trial of SPY001

Spyre Therapeutics, Inc. announced positive interim Phase 1 data from its first-in-human trial of SPY001, an investigational novel, extended half-life monoclonal antibody targeting a4ß7. SPY001 was well tolerated with pharmacokinetic (PK) data demonstrating a half-life of >90 days and pharmacodynamic (PD) data demonstrating complete target engagement at all time points available. Interim results from the trial, with data as of October 30, 2024, exceeded the Company's expectations and support the potential for SPY001 to become a next-generation anti-a4ß7 therapy and backbone for paradigm-changing combination therapies in IBD. The PK and PD results support optimized Phase 2 dosing including increased induction exposures with the potential to improve or accelerate efficacy compared to other anti-a4ß7 treatments and maintenance dosing on a potential Q3M and Q6M frequency via a single subcutaneous injection. Across single doses of up to 1000 mg and multiple doses of up to 600 mg, SPY001 was well-tolerated with no serious adverse events reported and all adverse events being mild in severity. Based on these data, and subject to regulatory feedback, the Company plans to initiate a Phase 2 platform trial in mid-2025 that will ultimately include SPY001, SPY002 (TL1A), SPY003 (IL-23) and combinations thereof, providing three optimized monotherapy readouts and three potentially paradigm-changing combination readouts under an efficient single master protocol. Key SPY001 Phase 1 Interim Findings: The SPY001 Phase 1 trial is a first-in-human, randomized, double-blind, placebo-controlled trial designed to evaluate safety and PK of SPY001 in healthy volunteers. To date, the trial has enrolled 56 healthy adult participants into five single-ascending dose (SAD) and two multiple-ascending dose (MAD) cohorts. Doses of SPY001 evaluated in the trial included single doses of 100 mg SC, 300 mg SC, 600 mg SC, 1,000 mg SC, and 1,000 mg IV and multiple doses of 300 mg SC and 600 mg IV. Findings from the interim SAD and MAD portions of the Phase 1 trial are as follows: Safety – well-tolerated across all dose groups: Single doses of SPY001 up to 1,000 mg and multiple doses of 600 mg were well tolerated with a favorable safety profile consistent with existing third-party data of the anti-a4ß7 class. The most common (i.e., occurring in more than one subject) treatment-emergent adverse events (TEAEs) were headache and nasopharyngitis. There were no Grade 2 or above TEAEs or serious adverse events ("SAEs"). No AEs led to trial discontinuation. PK – meaningfully differentiated profile relative to vedolizumab: Half-life estimate is >90 days in the 300mg SC cohort and >100 days in the 600mg SC cohort, approx. 4-fold greater than vedolizumab's 25-day human half-life. SPY001 half-life supports potential for maintenance dosing via a single subcutaneous injection on a Q3M and Q6M basis using a high-concentration, citrate-free formulation. Dose-proportionality and limited intrasubject variability observed across key parameters (e.g., Cmax, AUC), support planned Phase 2 induction dosing to evaluate exposures of SPY001 in 4th quartile of vedolizumab's exposures to potentially achieve greater clinical remission rates and/or more rapid clinical effect. No apparent impact of anti-drug antibodies observed on pharmacokinetic exposures. PD – complete saturation of a4ß7 receptor occupancy to latest time point available: Single 300 mg dose of SPY001 saturated a4ß7 receptor occupancy up to Day 57 (longest follow-up available with pharmacodynamic data). Exploratory immunophenotyping in progress, expected to be shared at upcoming academic conferences. Spyre expects to share data from additional cohorts and longer follow-up from existing cohorts at future medical meetings. Platform Phase 2 trial in Ulcerative Colitis: Pending regulatory feedback, Spyre plans to advance SPY001 into a double-blind, randomized, placebo-controlled, Phase 2 platform trial with a master protocol in patients with moderately-to-severely active ulcerative colitis. The platform trial is designed to efficiently evaluate each of Spyre's monotherapy and combination therapies against a common placebo control. The trial is also intended to evaluate the contribution of each monotherapy component to the safety and efficacy of Spyre's combination therapies. This Phase 2 ulcerative colitis trial is expected to initiate in mid-2025 with SPY001 and placebo arms, with SPY002, SPY003, and combination arms to be added following clinical data, nonclinical data, and regulatory feedback. The trial is expected to enroll approximately 500 subjects across treatment arms and consist of a 12-week, placebo-controlled induction period followed by a 38-week maintenance period. Updated portfolio guidance for maintenance dosing: Given the PK results of SPY001, the Company is updating its guidance for maintenance dosing across the portfolio to Q3M-Q6M for monotherapies and combinations. Updated guidance highlights Spyre's unique ability to target a product profile with potentially best-in-indication efficacy and convenience.

총 주주 수익률	-3.8%
미래 배당 수익률	0%
배당 성장률	n/a
다음 배당 지급일	n/a
배당락일	n/a
주당 배당금	n/a
배당 성향	n/a

구분	배당 수익률
회사 (SYRE)	n/a
시장 하위 25% (US)	1.4%
시장 상위 25% (US)	4.2%
업계 평균 (Biotechs)	2.3%
분석가 예측 (SYRE) (최대 3년)	0%

데이터	최종 업데이트 (UTC 시간)
기업 분석	2026/07/10 07:11
종가	2026/07/10 00:00
수익	2026/03/31
연간 수익	2025/12/31

패키지	데이터	기간	미국 소스 예시 ^*
기업 재무제표	10년	손익계산서 현금흐름표 대차대조표	SEC 양식 10-K SEC 양식 10-Q
분석가 컨센서스 추정치	+3년	재무 예측 분석가 목표주가	분석가 리서치 보고서 Blue Matrix
시장 가격	30년	주가 배당, 분할 및 기타 조치	ICE 시장 데이터 SEC 양식 S-1
지분 구조	10년	주요 주주 내부자 거래	SEC 양식 4 SEC 양식 13D
경영진	10년	리더십 팀 이사회	SEC 양식 10-K SEC 양식 DEF 14A
주요 개발	10년	회사 공시	SEC 양식 8-K

분석가	기관
Colleen Kusy	Baird
Mayur Somaiya	BMO Capital Markets Equity Research
Julian Harrison	BTIG

Spyre Therapeutics 배당 및 자사주 매입

배당 기준 점검 0/6

핵심 정보

최근 배당 및 자사주 매입 업데이트

Recent updates

Spyre Therapeutics, Inc.(NasdaqGS:SYRE) dropped from Russell 2000 Value Benchmark

Spyre Therapeutics, Inc. has filed a Follow-on Equity Offering in the amount of $500 million.

Chief Financial Officer notifies of intention to sell stock

Spyre Therapeutics: A Platform Where The Combination Strategy Is The Real Asset

Insider Divestment of $400 Million Sparks Governance Questions at Spyre Therapeutics

New minor risk - Share price stability

Spyre Shares Rise as SPY002 Shows Positive Phase 2 Results in Ulcerative Colitis Trial

Spyre Therapeutics, Inc. Announces Positive Initial 12-Week Induction Topline Data from Part A of Phase 2 SKYLINE Trial of SPY002 for Treatment Of Moderately-to-Severely Active Ulcerative Colitis

Spyre Therapeutics Completes Enrollment In SKYWAY Basket Trial Evaluating SPY072 In RA, PsA, And AxSpA

Spyre Therapeutics Sets 2026 Data Readouts and Expands SPY003 License Across Indications

Spyre Therapeutics, Inc. Announces Resignation of Peter Harwin from the Board, Effective Effective May 27, 2026

New minor risk - Share price stability

Spyre Therapeutics, Inc. has completed a Follow-on Equity Offering in the amount of $403 million.

Spyre Therapeutics, Inc. has filed a Follow-on Equity Offering in the amount of $300 million.

Price target increased by 11% to US$67.43

Spyre Therapeutics, Inc., Annual General Meeting, May 27, 2026

Price target increased by 9.9% to US$64.36

Spyre Therapeutics, Inc. Announces Acceleration of Expected Topline Readout of SKYWAY Rheumatoid Arthritis Sub-study to Third Quarter 2026

CEO & Director notifies of intention to sell stock

Spyre Therapeutics, Inc. Appoints Kate Tansey Chevlen as Chief Commercial Officer

New minor risk - Share price stability

Spyre Therapeutics Announces Positive Interim Phase 1 Results for SPY003, Its Novel, Half-Life Extended Anti-IL-23 Antibody

CEO & Director notifies of intention to sell stock

New major risk - Shareholder dilution

New minor risk - Share price stability

Spyre Therapeutics, Inc. has completed a Follow-on Equity Offering in the amount of $275.000003 million.

Spyre Therapeutics, Inc. Doses First Patient in Pioneering Phase 2 SKYway Basket Trial of SPY072, the First Anti-TL1A Antibody Studied in Rheumatic Diseases

Chief Financial Officer recently sold US$300k worth of stock

Companies Like Spyre Therapeutics (NASDAQ:SYRE) Are In A Position To Invest In Growth

High number of new and inexperienced directors

Spyre Therapeutics, Inc. Announces Positive Interim Phase 1 Results for Two Next-Generation TL1A Antibody Programs, and Provides Clinical Development Updates Expected to Deliver 9 Phase 2 Readouts

Spyre Therapeutics, Inc. Announces Poster Presentations at Digestive Disease Week 2025 Including Up to Eight Months of Follow-Up from an Ongoing Phase 1 Trial of SPY001

Spyre Therapeutics, Inc., Annual General Meeting, May 29, 2025

Spyre Therapeutics Announces First Participant Dosed in Phase 1 Trial of Spy003, Its Novel Half-Life Extended Il-23 Antibody

Spyre Therapeutics: Targeting The Future Of IBD Treatment

Spyre Therapeutics: Different Name, Same Tune

Spyre Therapeutics Announces First Participants Dosed in Phase 1 Trials of Novel Half-Life Extended Anti-Tl1a Antibodies

Spyre Therapeutics, Inc. has completed a Follow-on Equity Offering.

Spyre Therapeutics, Inc. has filed a Follow-on Equity Offering in the amount of $200 million.

Spyre Therapeutics, Inc. Announces Positive Interim Phase 1 Data from its First-In-Human Trial of SPY001

Spyre: Extended Half-Life Tech To Become Differentiating Factor For IBD Targeting

Spyre Therapeutics Appoints Dr. Sheldon Sloan as Chief Medical Officer

Spyre Therapeutics, Inc. Announces First Participants Dose in Phase 1 Trial of SPY001

Spyre Therapeutics, Inc. Announces Board Changes

Spyre Therapeutics, Inc., Annual General Meeting, May 13, 2024

Spyre Therapeutics, Inc. announced that it expects to receive $180.005 million in funding from a group of investors

Spyre Therapeutics, Inc. Announces Board Changes

Spyre Therapeutics, Inc. announced that it has received $180 million in funding from a group of investors

Spyre Therapeutics, Inc. announced that it expects to receive $180 million in funding from a group of investors

Spyre Therapeutics, Inc.(NasdaqCM:SYRE) dropped from NASDAQ Composite Index

Aeglea BioTherapeutics, Inc. Announces Appointment of Cameron Turtle as Principal Executive Officer

Aeglea Biotherapeutics, Inc. Regains Compliance with Nasdaq Listing Rule

Aeglea Biotherapeutics Expands Executive Leadership Team with Appointment of Industry Veterans Scott Burrows and Heidy Abreu King-Jones

Immedica Pharma signed an agreement to acquire global rights to pegzilarginase from Aeglea BioTherapeutics, Inc from Aeglea BioTherapeutics, Inc. (NasdaqCM:AGLE) for $115 million.

Aeglea Biotherapeutics Receives Approval from Nasdaq of the Transfer of the Listing of Its Common Stock from Nasdaq Global Market to the Nasdaq Capital Market

High number of new directors

Aeglea BioTherapeutics, Inc. announced that it expects to receive $210.000248 million in funding from a group of investors

New major risk - Share price stability

Aeglea Biotherapeutics, Inc. Announces the Termination of Jeffrey Goldberg as Chief Executive Officer

Aeglea BioTherapeutics, Inc. Announces Executive Changes

Consensus revenue estimates increase by 48%

Price target increased by 20% to US$3.12

Consensus EPS estimates upgraded to US$0.61 loss

Price target decreased by 16% to US$2.27

No longer forecast to breakeven

Aeglea BioTherapeutics Receives Written Notice from The Nasdaq Stock Market, LLC Regarding Minimum Bid Price Requirement for Continued Listing

Aeglea Biotherapeutics, Inc. Announces Resignation of Leslie Sloan as Chief Operating Officer

Aeglea Biotherapeutics, Inc. Announces Chief Executive Officer Changes

Aeglea BioTherapeutics, Inc. Appoints Linda Neuman as Chief Medical Officer

Price target increased to US$2.70

Consensus forecasts updated

Price target increased to US$2.70

Aeglea BioTherapeutics, Inc. Provides Clinical Progress and Regulatory Update for Homocystinuria Program

Insider recently bought US$50k worth of stock

Aeglea Biotherapeutics Announces Leadership Transition