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AnaptysBio, Inc. (Nasdaq: ANAB) is a clinical-stage biotechnology company dedicated to developing innovative immunology therapeutics to address unmet medical needs. Founded in 2005, AnaptysBio leverages its proprietary SHM-XEL platform to generate high-affinity therapeutic antibodies by harnessing the natural process of somatic hypermutation (SHM) under controlled conditions. The SHM-XEL platform mimics key features of the human immune system and overcomes the limitations of prior antibody technologies.
Headquartered in San Diego, AnaptysBio is focused on creating a robust pipeline of novel therapeutic antibody candidates targeting autoimmune, inflammatory, and oncology indications. The company boasts a portfolio that includes clinical-stage immune cell modulators such as rosnilimab (PD-1 agonist) and ANB032 (BTLA agonist), both in Phase 2 trials for rheumatoid arthritis (RA), ulcerative colitis (UC), and atopic dermatitis (AD).
AnaptysBio has shown significant progress in its clinical programs. Notably, the company reported positive top-line results from its global Phase 3 GEMINI-1 and GEMINI-2 trials evaluating imsidolimab (IL-36R mAb) for generalized pustular psoriasis (GPP). The results demonstrated rapid clearance of GPP symptoms with a single intravenous dose followed by effective maintenance with monthly subcutaneous doses.
Financially, AnaptysBio is on solid ground, reiterating a cash runway through year-end 2026 with expected year-end 2023 cash and investments of $400 to $410 million. The company's strategic collaborations, including its partnership with GSK for Jemperli (dostarlimab-gxly), provide additional financial support and validation of their therapeutic candidates' commercial potential.
Recently, AnaptysBio announced an exclusive license agreement with Centessa Pharmaceuticals for a BDCA2 modulator portfolio, including ANB101, further expanding its pipeline. The company plans to submit investigational new drug (IND) applications for ANB033 (anti-CD122 antagonist) and ANB101 in 2024.
With a commitment to patient-centric innovation and a strategic approach to partnerships and financial management, AnaptysBio continues to advance its mission of delivering transformative therapies to improve patients' lives globally.
AnaptysBio announced that the Phase 3 RUBY trial of JEMPERLI plus chemotherapy met its primary endpoint, significantly improving progression-free survival (PFS) in patients with advanced or recurrent endometrial cancer. The trial's favorable results for the dMMR/MSI-H subgroup could drive substantial royalties for AnaptysBio. Regulatory submissions are expected in early 2023, with GSK planning to publish full results soon. JEMPERLI, developed by AnaptysBio, is a PD-1-blocking antibody indicated for specific endometrial cancer cases.
AnaptysBio, a clinical-stage biotechnology firm, announced that CEO Dan Faga will participate in a fireside chat at the Guggenheim 4th Annual Immunology and Neurology Conference on November 14, 2022. The session is scheduled for 1:00 p.m. ET. Additionally, the senior management team will conduct investor meetings at the Jefferies London Healthcare Conference on November 16, 2022. An audio webcast of the event will be available on AnaptysBio's investor website and can be replayed for 30 days post-event.
AnaptysBio reported its Q3 2022 operating results, highlighting key developments in its immune cell modulator pipeline. The company anticipates top-line data for its anti-PD-1 agonist, Rosnilimab, in Q1 2023, and has progressed its anti-BTLA agonist, ANB032, towards a Phase 2 trial with IND submission expected in Q4 2022. The company sold its Zejula royalty interest for up to $45 million. Despite having $590 million in cash, AnaptysBio faced a net loss of $33.5 million, a significant increase from last year, attributed to rising general and administrative expenses.
AnaptysBio announced positive results from the PERLA Phase 2 trial, comparing JEMPERLI against Keytruda in metastatic non-squamous lung cancer, achieving its primary endpoint of objective response rate (ORR). Additionally, the COSTAR trial, evaluating JEMPERLI in combination with cobolimab, met its pre-specified efficacy and safety criteria, allowing progression to Phase 3. AnaptysBio expects to receive a $5 million milestone payment from GSK upon dosing the first patient in the Phase 3 COSTAR trial. JEMPERLI is being developed for various advanced cancers, while cobolimab is an investigational TIM-3 antagonist.
AnaptysBio, a clinical-stage biotechnology company, announced the sale of its royalty interest in Zejula to DRI Healthcare Trust for up to $45 million. The company received an upfront payment of $35 million for a 1% royalty on global net sales, which is effectively 0.5% due to third-party royalties. AnaptysBio stands to gain an additional $10 million contingent upon FDA approval of Zejula for endometrial cancer, expected by December 31, 2025. This sale supports their focus on innovative immunology therapeutics.
AnaptysBio announced disappointing results from its HARP Phase 2 trial of imsidolimab, an anti-IL-36 receptor antagonist for hidradenitis suppurativa, which showed no significant efficacy over placebo in primary and key secondary endpoints. The company will discontinue this clinical development but continues to enroll patients in the GEMINI-1 Phase 3 trial for generalized pustular psoriasis (GPP), with top-line data expected in Q4 2023. AnaptysBio plans to outlicense imsidolimab prior to FDA approval and shift focus to its immune cell modulator pipeline, including two checkpoint agonists, rosnilimab and ANB032.
AnaptysBio (ANAB) reported Q2 2022 results, highlighting an operating cash position of $572.1 million, with anticipated net cash burn estimated at $90-$100 million for 2022.
Collaboration revenue fell significantly to $1.2 million compared to $30 million a year prior. Research and development expenses decreased to $20.8 million, while general and administrative costs increased to $8.2 million due to personnel changes. The company posted a net loss of $32.6 million for Q2, with a net loss per share of $1.15, up from a $0.4 million loss in Q2 2021.
AnaptysBio, a clinical-stage biotechnology firm, is set to participate in a fireside chat at the Wedbush PacGrow Healthcare Virtual Conference on August 10, 2022, at 3:30 p.m. ET. CEO Dan Faga and CMO Paul Lizzul will represent the company. The presentation will be available via live audio webcast on AnaptysBio's investor website, with a replay accessible for 90 days post-event. AnaptysBio specializes in immunology therapeutics, with a focus on developing innovative treatments for inflammatory diseases, leveraging its proprietary antibody discovery platform.
AnaptysBio, a clinical-stage biotechnology company (Nasdaq: ANAB), announced that CEO Dan Faga and CMO Paul Lizzul will speak at the Jefferies Healthcare Conference on June 8, 2022, at 10:00 a.m. ET. A live audio webcast will be accessible on their investor website, with a replay available for 90 days.
The company develops first-in-class antibodies targeting inflammation and immuno-oncology. Their pipeline includes imsidolimab for dermatological conditions and rosnilimab for alopecia areata, among others, utilizing their proprietary somatic hypermutation platform for antibody discovery.
AnaptysBio reported its Q1 2022 financial results with cash reserves at approximately $596.8 million. The company anticipates key trial data releases: the GEMINI-1 Phase 3 trial for imsidolimab in generalized pustular psoriasis by Q4 2023, and top-line results from the HARP Phase 2 trial for hidradenitis suppurativa in Q3 2022. A decrease in collaboration revenue to $1.0 million was noted, down from $11.2 million in Q1 2021. R&D expenses decreased to $22.5 million, while G&A expenses surged to $10.2 million due to one-time costs. The net loss was $36.3 million, reflecting a per-share loss of $1.31.
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