On track for 6 proof-of-concept readouts in 2026 across the SKYLINE and SKYWAY Phase 2 trials Part A readouts from SKYLINE platform trial in ulcerative colitis ("UC") expected to begin in the second quarter, with enrollment continuing ahead of schedule Enrollment on track in Phase 2 SKYWAY basket trial evaluating TL1A inhibition in rheumatoid arthritis ("RA"), psoriatic arthritis ("PsA"), and axial spondyloarthritis ("axSpA"), with fourth quarter readouts expected in each sub-study Strengthened the balance ...

WALTHAM, Mass., Feb. 18, 2026 (GLOBE NEWSWIRE) -- Spyre Therapeutics, Inc. (NASDAQ: SYRE), a clinical-stage biotechnology company pioneering long-acting antibodies and antibody combinations to redefine the standard of care for inflammatory bowel disease (“IBD”) and rheumatic diseases, today announced scientific presentations at the 21st Congress of the European Crohn’s and Colitis Organisation (ECCO), held February 18-21, 2026 in Stockholm, Sweden. “We are excited to share follow-up data out to 20 weeks fro ...

Group 1 - Spyre Therapeutics (NASDAQ:SYRE) is identified as one of the 17 biotechnology stocks with more than 50% upside potential, with a projected median 1-year price target of $57.86, indicating an upside of over 66% [1] - The company has received coverage from 7 analysts, all of whom have assigned Buy ratings, reflecting a strongly bullish consensus sentiment [1] - As of January 22, 2026, Spyre Therapeutics plans to prioritize six proof-of-concept (POC) readouts, with the SKYLINE ulcerative colitis trial completing SPY001 enrollment ahead of schedule, and the SKYWAY basket trial on track for fourth-quarter readouts in 2026 [2] Group 2 - Financially, Spyre Therapeutics reported $783 million in pro forma cash, cash equivalents, and marketable securities as of September 30, 2025, providing a runway through the second half of 2028 [2] - The company is a clinical-stage biotechnology firm focused on developing advanced antibody therapeutics for inflammatory bowel disease (IBD), including conditions such as ulcerative colitis and Crohn's disease [3] - Spyre's current pipeline includes multiple candidates: SPY001, SPY002, SPY003, and various combination therapies [3]

Core Viewpoint - Spyre Therapeutics, Inc. (NASDAQ:SYRE) is recognized as one of the top stocks to buy, with strong buy ratings from multiple analysts and significant growth potential in its pipeline for treating inflammatory bowel disease (IBD) [1][2][4]. Group 1: Analyst Ratings and Price Targets - Wells Fargo has reiterated a Buy rating on SYRE with a price target of $40 [1]. - Mizuho initiated coverage with an Outperform rating and a price target of $53, highlighting the potential of the company's anti-monoclonal antibodies for IBD [2]. - Wall Street analysts have a consensus Strong Buy rating with an average one-year price target of $56.67, indicating a potential upside of 72.77% [4]. Group 2: Clinical Trials and Drug Development - Spyre Therapeutics reported positive results from its Phase 1 trial of SPY003, an extended half-life antibody for IBD, showing a half-life of nearly 85 days across 59 participants [3]. - The company is focused on developing treatments for inflammatory bowel and rheumatic diseases, which positions it well for future growth [5]. Group 3: Financial Performance - The company's shares have increased by over 69% in the last three months, driven by positive trial results and favorable analyst updates [5]. - The third-quarter results showed a significant reduction in net loss, decreasing from $69 million in the previous year to $11.2 million [5]. Group 4: Future Projections - Mizuho projects that Spyre Therapeutics' global sales could reach $1.7 billion by 2035, indicating strong long-term growth potential [4].

Core Insights - Spyre Therapeutics, Inc. (NASDAQ:SYRE) announced positive interim Phase 1 results for its novel Anti-IL-23 antibody, SPY003, which is being tested for inflammatory bowel disease and rheumatic diseases [1][2] - The drug demonstrated a half-life of approximately 85 days, allowing for maintenance dosing every three to six months, and showed a favorable safety profile with no serious adverse events reported [2] - Analyst Julian Harrison of BTIG maintained a Buy rating on SYRE with a price target of $70, highlighting the extended half-life as a significant advancement for combination therapies [3][4] Company Overview - Spyre Therapeutics is a clinical-stage biotechnology company focused on developing antibody-based therapies for inflammatory bowel disease and other immune-related conditions [4] - The company has a unique capability to combine multiple monoclonal antibodies into a single treatment, enhancing its therapeutic offerings [4] - Financially, Spyre Therapeutics is well-positioned with a substantial cash runway to fund operations until the second half of 2028 [4]

Core Viewpoint - The article discusses the bullish outlook for small- and mid-cap stocks, highlighting their potential for earnings growth as the market approaches the end of the year, with expectations for a catch-up in performance compared to large-cap stocks driven by favorable market conditions and improved earnings guidance [2][3][4]. Small and Mid-Cap Stocks Outlook - Scott Chronert, Citi's U.S. equity strategist, emphasizes that small and mid-cap stocks are expected to transition from low single-digit earnings growth in 2025 to low double-digit growth in 2026 [3]. - The recent Q3 earnings reports from small-cap companies have shown raised guidance for Q4 and 2026, indicating a positive trend for these stocks [3]. - The small-cap sector is coming off a two-year period of low earnings, which sets a favorable comparison for future growth [3]. Methodology for Stock Selection - The list of the 10 hottest small-cap stocks was compiled using the Finviz Stock Screener, WSJ, Yahoo Finance, and Insider Monkey's Q2 2025 database, focusing on stocks with market capitalizations between $300 million and $2 billion that gained over 50% in the past six months [7]. - Stocks were ranked based on the number of hedge fund holders, indicating interest from institutional investors [7][8]. Featured Small-Cap Stocks - **Aveanna Healthcare Holdings Inc. (NASDAQ:AVAH)**: - Market Capitalization: $1.88 billion - 6-Month Performance: 55.36% - Revenue grew by 22.2% year-over-year to $621.9 million, exceeding analyst expectations [10][12]. - Adjusted EBITDA increased by 67.5% year-over-year to $80.1 million, with management raising full-year revenue guidance to over $2.375 billion [13][14]. - **Spyre Therapeutics, Inc. (NASDAQ:SYRE)**: - Market Capitalization: $1.81 billion - 6-Month Performance: 56.40% - Positive interim Phase 1 results for SPY003, a novel treatment for inflammatory bowel disease, were announced, showing a favorable safety profile [15][16]. - The company is well-positioned financially with a substantial cash runway to support operations until the second half of 2028 [18].

Core Insights - Spyre Therapeutics reported positive interim Phase 1 results for SPY003, a next-generation anti-IL-23 antibody, indicating a well-tolerated profile and an approximately 85-day half-life, supporting quarterly or biannual maintenance dosing [1] - The company initiated the Phase 2 SKYWAY basket study for SPY072, focusing on TL1A inhibition in rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis [1] - Spyre is on track for six proof-of-concept readouts in 2026 across the SKYLINE and SKYWAY Phase 2 trials [1] - The company strengthened its balance sheet with $316 million in gross proceeds from a public offering, resulting in $783 million in pro forma cash as of September 30, 2025, with a projected runway into the second half of 2028 [1][13] Company Overview - Spyre Therapeutics is a clinical-stage biotechnology company focused on long-acting antibodies and antibody combinations aimed at redefining the standard of care for inflammatory bowel disease and rheumatic diseases [1][16] - The company’s pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23, with a market potential exceeding $60 billion in annual revenue across its indications [2][3] Development Pipeline - The company is advancing multiple investigational antibodies, including SPY001, SPY002, SPY003, and SPY072, targeting validated mechanisms for the treatment of inflammatory bowel disease and rheumatic diseases [4][10][11] - SPY001 targets α4β7 and is designed for infrequent subcutaneous maintenance dosing, while SPY002 and SPY072 are anti-TL1A monoclonal antibodies also engineered for extended half-lives [5][6][7] - The SKYLINE Phase 2 platform trial includes SPY001, SPY002, and SPY003, with Part A focusing on safety and preliminary efficacy, and Part B planned for randomized assessments [10] Financial Performance - As of September 30, 2025, Spyre reported cash, cash equivalents, and marketable securities totaling $486.2 million, with pro forma cash reflecting $782.7 million after a recent public offering [13] - Research and development expenses for Q3 2025 were $45.2 million, slightly higher than $44.7 million in Q3 2024, driven by increased clinical trial costs [14] - The net loss for Q3 2025 was $11.2 million, a significant improvement from a net loss of $69.0 million in Q3 2024 [15][27]

Core Insights - Spyre Therapeutics announced positive interim Phase 1 results for SPY003, an investigational extended half-life antibody targeting IL-23, which supports its potential for quarterly or biannual maintenance dosing [1][2][8] Group 1: Clinical Trial Results - SPY003 demonstrated a favorable safety profile in a Phase 1 trial with 59 healthy adult participants, showing it was well tolerated across all dose levels [3][5] - The trial included various dosing cohorts, with the most common treatment-emergent adverse event being headache, and no serious adverse events reported [3][4] - SPY003 exhibited a half-life of approximately 85 days, significantly longer than risankizumab, indicating potential for less frequent dosing [5][8] Group 2: Future Development Plans - The positive results from the Phase 1 trial will allow SPY003 to advance to the ongoing Part A of the SKYLINE Phase 2 platform trial [1][2] - The SKYLINE and SKYWAY trials are expected to yield six proof-of-concept readouts by 2026, further validating the efficacy and safety of SPY003 [1][2] Group 3: Company Overview - Spyre Therapeutics is focused on developing long-acting antibodies and antibody combinations to improve treatment standards for inflammatory bowel disease (IBD) and rheumatic diseases [9] - The company’s pipeline includes investigational therapies targeting α4β7, TL1A, and IL-23, aiming to create a comprehensive IBD portfolio [2][9]

Core Insights - Spyre Therapeutics reported positive interim Phase 1 results for two next-generation TL1A antibodies, indicating they were well-tolerated and supported quarterly or biannual dosing with full TL1A engagement for up to 20 weeks [1][2] - The company initiated the Phase 2 SKYLINE-UC platform study to evaluate three optimized monotherapies and three potentially paradigm-changing combinations for ulcerative colitis [1][3] - Spyre is on track to begin the Phase 2 SKYWAY-RD basket study for TL1A inhibition in rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis in Q3 2025 [1][10] - The company has a strong cash position of $526.6 million as of June 30, 2025, with an expected runway into the second half of 2028 [1][11] Development Pipeline Overview - Spyre's approach combines advanced antibody engineering, dose optimization, and rational therapeutic combinations to enhance efficacy and convenience in treating inflammatory bowel disease (IBD) and other immune-mediated diseases [3][15] - IBD affects approximately 2.4 million individuals in the U.S., while rheumatoid arthritis (RA), psoriatic arthritis (PsA), and axial spondyloarthritis (axSpA) affect over 1.5 million and nearly 3 million individuals, respectively [3][4] Financial Performance - Research and Development (R&D) expenses for Q2 2025 totaled $40.1 million, up from $32.6 million in Q2 2024, primarily due to increased clinical trial expenses [12] - General and Administrative (G&A) expenses were $11.8 million for Q2 2025, slightly higher than $11.5 million in Q2 2024 [12] - The net loss for Q2 2025 was $36.7 million, compared to a net loss of $38.8 million in Q2 2024, including non-cash stock-based compensation expenses [14][24]

Clinical Trial Updates - SPY002 and SPY072 met Phase 1 objectives, and the company plans to advance both into Phase 2[18] - The company is launching SKYLINE-UC, a Phase 2 platform study in ulcerative colitis evaluating three monotherapies and three combinations[11, 58] - The company is unveiling SKYWAY-RD, a Phase 2 basket study evaluating anti-TL1A in three rheumatologic conditions[11, 75] - The company anticipates 9 proof-of-concept readouts in 2026-27 for the treatment of IBD and beyond[25, 103] SPY002 and SPY072 Phase 1 Results - In a Single Ascending Dose (SAD) study, 11 out of 40 (28%) subjects in the SPY002 group experienced at least one Treatment Emergent Adverse Event (TEAE)[36] - In a Single Ascending Dose (SAD) study, 14 out of 40 (35%) subjects in the SPY072 group experienced at least one Treatment Emergent Adverse Event (TEAE)[38] - SPY002 demonstrated an approximate 75-day half-life[40, 42] - SPY002 and SPY072 suppressed free TL1A through 20-weeks of follow-up at the lowest dose tested[43] Trial Design and Cost Efficiency - The Phase 2 platform trial in UC is expected to achieve 40% cost savings compared to individual Phase 2 studies[24] - The Phase 2 basket trial in rheumatological diseases is expected to achieve 35% cost savings compared to individual Phase 2 studies[24] Financial Runway - The company has $565 million cash with runway into the second half of 2028[103]