Core Viewpoint - AnaptysBio, Inc. shares experienced a significant rally of 30.5% following positive results from a mid-stage study of its investigational candidate, rosnilimab, for moderate-to-severe rheumatoid arthritis, despite a prior 17% loss over the past four weeks [1][2]. Company Performance - AnaptysBio's stock closed at $16.15 after notable trading volume [1]. - The company is expected to report a quarterly loss of $1.61 per share, reflecting a year-over-year change of -1.3%, with anticipated revenues of $10.17 million, representing a 12.8% increase from the previous year [3]. Study Results - Rosnilimab met its primary endpoint in the phase IIb RENOIR study for rheumatoid arthritis, achieving statistical significance at one dose and numerical superiority across all doses at week 12 [2]. - The study also achieved key secondary endpoints, with the highest responses recorded at week 14, despite elevated placebo rates [2]. - Full 28-week data from the RA study is expected to be shared in Q2 2025, and top-line data for ulcerative colitis is anticipated in Q4 2025 [2]. Earnings Estimates - The consensus EPS estimate for AnaptysBio has been revised 5.4% higher over the last 30 days, indicating a positive trend that may lead to price appreciation [4]. - The stock currently holds a Zacks Rank of 2 (Buy), suggesting potential for further strength [4]. Industry Context - AnaptysBio operates within the Zacks Medical - Biomedical and Genetics industry, where another company, Pacira, has also shown strong performance with a 32.6% return over the past month [4]. - Pacira's consensus EPS estimate has increased by 4.1% to $0.85, although this reflects a year-over-year change of -4.5% [5].

AnaptysBio (ANAB) Update / Briefing February 12, 2025 08:30 AM ET Company Participants Daniel Faga - President & CEOPaul Lizzul - Chief Medical OfficerDavid Nierengarten - Managing Director - Equity ResearchAlex Thompson - Managing DirectorEmily Bodnar - Vice President of Equity ResearchEllie Merle - ED - Biotech Equity Research Conference Call Participants Joseph Thome - AnalystYasmeen Rahimi - Sr. Research AnalystDavid Risinger - Senior Managing Director & Senior Research AnalystDerek Archila - AnalystYat ...

Core Insights - AnaptysBio, Inc. announced statistically significant Week 12 data from the Phase 2b RENOIR trial for rosnilimab, a treatment for moderate-to-severe rheumatoid arthritis (RA) [1][4][9] - Rosnilimab demonstrated a favorable safety profile, with adverse event rates similar to placebo [1][12][13] Group 1: Trial Overview - The Phase 2b RENOIR trial involved 424 patients with moderate-to-severe RA, assessing the efficacy, safety, and pharmacokinetics of rosnilimab [2][4] - Patients were randomized to receive different doses of rosnilimab or placebo, with primary and secondary endpoints evaluated at Weeks 12 and 14 [3][4] Group 2: Efficacy Results - Rosnilimab achieved its primary endpoint with a mean change from baseline in DAS-28 CRP at Week 12 for all doses compared to placebo [4][7] - Key secondary endpoints, including ACR20, ACR50, and CDAI LDA, showed statistical significance at Week 12, with 69% of patients achieving CDAI LDA at Week 14 [5][7][10] Group 3: Pharmacological Activity - Translational blood biomarker data indicated a robust pharmacological effect, with a ~90% reduction in PD-1 T cells and a ~50% reduction in PD-1+ T cells observed in rosnilimab-treated patients [6][8] - The treatment resulted in a favorable T cell composition and a ~50% reduction in mean CRP levels, indicating effective inflammation control [6][8] Group 4: Safety Profile - The safety data through Week 12 showed that 48% of patients on 100mg Q4W, 45% on 400mg Q4W, and 36% on 600mg Q2W experienced any adverse events, comparable to 34% in the placebo group [12][13] - No malignancies or major adverse cardiovascular events were reported, and the incidence of serious infections was similar to placebo [13][14] Group 5: Future Outlook - Full Week 28 data and additional translational data are expected in Q2 2025, with top-line data for ulcerative colitis anticipated in Q4 2025 [7][9][20] - The company aims to address the unmet need for innovative RA therapies, highlighting the potential of rosnilimab to provide durable relief and disease modification [11][14]

SAN DIEGO, Feb. 11, 2025 (GLOBE NEWSWIRE) -- AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, will host an investor call and live webcast to review top-line data from the global Phase 2b RENOIR clinical trial of investigational rosnilimab, a depleter and agonist of PD-1+ T cells, for moderate-to-severe rheumatoid arthritis on Wednesday, Feb. 12, 2025, at 8:30am ET / 5:30am PT. A live webcast of the call will be available on the ...

SAN DIEGO, Feb. 03, 2025 (GLOBE NEWSWIRE) -- AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, today announced that Daniel Faga, president and chief executive officer of Anaptys, will present at the Guggenheim SMID Cap Biotech Conference on Wednesday, Feb. 5, 2025 at 1:00pm ET / 10:00am PT. A live webcast of the presentation will be available on the investor section of the Anaptys website at http://ir.anaptysbio.com/events. A re ...

Imsidolimab has successfully completed two global Phase 3 studies in Generalized Pustular PsoriasisVanda expects to immediately begin preparing BLA and MAA applications for the US and EUAnaptys to receive $15 million from Vanda, comprised of a $10 million upfront payment and $5 million for existing drug supplyAnaptys to receive a 10% royalty on global net sales of imsidolimab WASHINGTON and SAN DIEGO, Feb. 03, 2025 (GLOBE NEWSWIRE) -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ:VNDA) and AnaptysBio, Inc. (An ...

Company Summary - AnaptysBio, Inc. (ANAB) is currently positioned as an intriguing investment choice due to solid earnings estimate revisions and a favorable Zacks Rank of 2 (Buy) [1][4]. - Over the past month, the current quarter earnings estimates have improved from a loss of $1.63 per share to a loss of $1.61 per share, while the current year estimates have narrowed from a loss of $6.10 per share to a loss of $6.08 per share [4]. Industry Summary - The Medical - Biomedical and Genetics industry is experiencing positive trends, reflected in its Zacks Industry Rank of 63 out of more than 250 industries, indicating a strong position compared to other segments [2]. - The overall strength of the industry suggests that rising trends may benefit multiple securities within this sector, making it an attractive area for investment [2][5].

Company Presentation - AnaptysBio Inc's president and CEO Daniel Faga will present at the 43rd Annual J P Morgan Healthcare Conference on January 14 2025 at 4 30pm PT 7 30pm ET [1] - A live webcast of the presentation will be available on the investor section of the Anaptys website with a replay available for at least 30 days following the event [2] Company Overview - AnaptysBio is a clinical-stage biotechnology company focused on innovative immunology therapeutics for autoimmune and inflammatory diseases [3] - The company's lead program rosnilimab is in Phase 2b trials for rheumatoid arthritis and Phase 2 trials for ulcerative colitis [3] - AnaptysBio's portfolio includes ANB033 in Phase 1 trials and ANB101 soon to enter clinical development [3] - The company has licensed multiple therapeutic antibodies to GSK including an anti-PD-1 antagonist and an anti-TIM-3 antagonist [3] Contact Information - Nick Montemarano Senior Director of Investor Relations and Strategic Communications can be reached at 858 732 0178 or investors@anaptysbio com [4]

Core Viewpoint - AnaptysBio, Inc. (ANAB) experienced a significant decline in share price by 32.8% following the announcement of unsuccessful results from its phase IIb study of ANB032, a BTLA agonist, leading to the discontinuation of further investment in this asset [1][2][9]. Company Performance - AnaptysBio's stock has decreased by 27.6% year-to-date, contrasting with an industry decline of 8.1% [3]. Study Details - The ARISE-AD study assessed the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of ANB032 in patients with moderate-to-severe atopic dermatitis, enrolling 201 patients with a mean baseline EASI score of 27.3 [4][5]. - Patients were randomized to receive different dosages of ANB032 or placebo over 12 weeks, but the drug did not meet the primary endpoint of achieving at least a 75% improvement in EASI score [6]. - None of the secondary endpoints were met, including EASI-90 and itch severity reduction, with higher placebo response rates observed particularly in the U.S. [7]. Safety Profile - Despite the disappointing efficacy results, ANB032 was well tolerated across all doses, with no safety signals reported [8]. Future Focus - AnaptysBio plans to shift focus to other candidates, including rosnilimab for rheumatoid arthritis and ANB033 and ANB101 in clinical development [10][11]. - The company anticipates a cash balance of approximately $415 million by the end of 2024, extending its cash runway guidance through the end of 2027 [12].

Core Insights - AnaptysBio, Inc. announced that investigational ANB032 did not meet primary and secondary endpoints in the ARISE-AD trial for moderate-to-severe atopic dermatitis [1][4] - The company will discontinue further investment in ANB032 and focus on its autoimmune portfolio [2] - ANB032 was well tolerated with no safety signals observed across all doses [6] Study Details - The ARISE-AD trial enrolled 201 patients with a mean baseline EASI score of 27.3, including both biologics naïve and experienced patients [2] - Patients were randomized to receive different dosing regimens of ANB032 or placebo for 12 weeks [3] - The primary endpoint was not met, with no significant improvement in EASI-75 or other secondary endpoints at Week 14 [4] Efficacy Observations - Absolute response rates approached the minimum target product profile, but higher placebo response rates were noted, particularly in the U.S. [5] - Despite the lack of efficacy, ANB032 was reported to be safe and well tolerated [6] Market Reaction - Following the announcement, AnaptysBio's stock price fell by 36.3%, trading at $14.72 [7]