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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 FDA approval for JEMPERLI (dostarlimab-gxly) to treat recurrent or advanced endometrial cancer with mismatch repair deficiency. This milestone marks the first FDA approval for one of its antibodies, resulting in a $20 million milestone payment. AnaptysBio is eligible for additional milestone payments totaling $210 million and royalties ranging from 8% to 25% on global sales. The drug's approval is based on tumor response rate and durability, but continued approval may depend on confirmatory trials.
AnaptysBio, a clinical-stage biotechnology company, has appointed Oleg Nodelman to its Board of Directors. Nodelman, recognized for his expertise in biotechnology development and financing, is expected to contribute significantly to the company’s antibody discovery and development efforts. AnaptysBio specializes in first-in-class antibody product candidates addressing inflammation and immuno-oncology conditions. The company has advanced eight novel therapeutics into clinical development, leveraging its proprietary somatic hypermutation platform.
On March 8, 2021, AnaptysBio reported that its Phase 2 trial of imsidolimab for moderate-to-severe palmoplantar pustulosis (PPP) did not meet the primary endpoint of statistically significant improvement over placebo at week 16. The treatment was well tolerated, with no serious adverse events reported. AnaptysBio will not pursue further development in PPP but will advance imsidolimab in five other indications, including a Phase 3 trial in generalized pustular psoriasis (GPP) expected in mid-2021. Key results showed similar levels of improvement between treatment and placebo groups, with p-values indicating no significant differences.
AnaptysBio (Nasdaq: ANAB) reported positive topline data from its Phase 2 GALLOP trial of imsidolimab for generalized pustular psoriasis (GPP) in 2020, with Phase 3 initiation expected mid-2021. Additionally, the company is expanding imsidolimab trials into other dermatological conditions and has advanced ANB030 into Phase 1 trials. Key financial updates include a decrease in cash to $411.2 million, while collaboration revenue surged to $75 million due to milestone payments. The net income for Q4 2020 was $33.6 million, reflecting progress despite an annual net loss of $19.9 million.
AnaptysBio, a clinical-stage biotechnology company (Nasdaq: ANAB), announced that CEO Hamza Suria will present at the 39th Annual J.P. Morgan Healthcare Conference on January 14, 2021, at 9:10 a.m. ET. The virtual presentation will be available via a webcast, with a replay accessible for 30 days post-event. AnaptysBio specializes in developing first-in-class antibody product candidates targeting inflammation and immuno-oncology. Their pipeline includes treatments for rare inflammatory diseases and chronic conditions, utilizing a proprietary antibody discovery platform.
AnaptysBio, a clinical-stage biotechnology company (Nasdaq: ANAB), has announced that CEO Hamza Suria will present at the 2020 Jefferies London Virtual Healthcare Conference on November 17, 2020, at 12:35 p.m. ET. The conference will be held virtually, with a live presentation accessible on AnaptysBio’s investor website.
AnaptysBio specializes in first-in-class antibody product candidates targeting immune control mechanisms for inflammation and immuno-oncology. Their pipeline includes several innovative candidates like imsidolimab and ANB030, developed using their proprietary somatic hypermutation platform.
AnaptysBio reported promising interim results from its GALLOP Phase 2 trial of imsidolimab for treating moderate to severe Generalized Pustular Psoriasis (GPP), with a 94% reduction in skin pustules after 29 days. The company expects to engage with the FDA for a registration path in Q4 2020. Additionally, the POPLAR Phase 2 trial for palmoplantar pustulosis has been fully enrolled, and topline data is expected in Q1 2021. An amended collaboration with GlaxoSmithKline aims to enhance dostarlimab royalties, with $20 million in milestone payments anticipated for 2020.
AnaptysBio, a clinical-stage biotechnology company, announced an amendment to its collaboration agreement with GlaxoSmithKline (GSK) that significantly increases royalties on its immuno-oncology drug, dostarlimab. The royalty rates will now range from 8% to 25% of global net sales, with an anticipated FDA approval for endometrial cancer in Q4 2020. Additionally, GSK will make a one-time cash payment of $60 million and provide a 1% royalty on Zejula™ sales starting January 2021. AnaptysBio expects $75 million in cash milestones over the next 18 months.
AnaptysBio announced positive topline data from the Phase 2 GALLOP trial of imsidolimab for treating generalized pustular psoriasis (GPP). Six out of eight patients achieved the primary endpoint of clinical improvement on Day 29, with skin pustules decreasing by 60% by Day 8 and 94% by Day 29. The company anticipates an FDA end-of-Phase 2 meeting in Q4 2020 to discuss the registration pathway. Additionally, the Phase 2 trial for palmoplantar pustulosis will provide top-line data in Q1 2021, as will the initiation of a global registry for GPP and PPP patients.
AnaptysBio, a clinical-stage biotechnology company focused on antibody development, announced that CEO Hamza Suria will present at the 2020 Cantor Global Virtual Healthcare Conference on September 17, 2020, at 12:00 p.m. ET. The presentation will be accessible online, with a replay available for 90 days post-event. AnaptysBio's pipeline includes anti-IL-36R antibody imsidolimab and anti-IL-33 antibody etokimab, targeting rare inflammatory diseases and chronic conditions. The company employs a proprietary somatic hypermutation platform for antibody discovery.
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