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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 (NASDAQ: ANAB) announced significant positive results from its Phase 2b RENOIR trial of rosnilimab for moderate-to-severe rheumatoid arthritis (RA). The 424-patient global trial achieved its primary endpoint with statistical significance across all rosnilimab doses versus placebo at Week 12.
Key highlights include:
- 69% of rosnilimab-treated patients achieved CDAI low disease activity at Week 14
- Demonstrated highest ever reported responses on key secondary endpoints
- Showed sustained efficacy through Week 28
- Safe and well-tolerated with adverse event rates similar to placebo
The trial evaluated three dosing regimens: 100mg every four weeks, 400mg every four weeks, and 600mg every two weeks. The drug showed robust pharmacological activity with ~90% reduction in PD-1high T cells and ~50% reduction in CRP levels. Full Week 28 data expected in Q2 2025, with Phase 2 ulcerative colitis data anticipated in Q4 2025.
AnaptysBio (ANAB) has announced it will host an investor call and live webcast on February 12, 2025, at 8:30 AM ET to present top-line data from its global Phase 2b RENOIR clinical trial. The trial evaluates rosnilimab, a PD-1+ T cells depleter and agonist, for the treatment of moderate-to-severe rheumatoid arthritis. The data will be released through a morning press release and discussed during the webcast, which will be accessible via the company's investor relations website. A replay will remain available for at least 30 days after the event.
AnaptysBio (NASDAQ: ANAB), a clinical-stage biotechnology company specializing in innovative immunology therapeutics, has announced its participation in the upcoming Guggenheim SMID Cap Biotech Conference. Daniel Faga, the company's president and chief executive officer, will deliver a presentation on Wednesday, February 5, 2025, at 1:00 PM ET / 10:00 AM PT.
Interested parties can access a live webcast of the presentation through the investor section of the Anaptys website at http://ir.anaptysbio.com/events. The presentation recording will remain available for replay for a minimum of 30 days after the event.
Vanda Pharmaceuticals (VNDA) and AnaptysBio announced an exclusive global license agreement for imsidolimab, an IL-36R antagonist that has completed two Phase 3 trials for Generalized Pustular Psoriasis (GPP). Under the agreement, Vanda will pay $15 million upfront ($10M payment plus $5M for drug supply) and will receive exclusive global rights to develop, manufacture, and commercialize imsidolimab.
The drug has successfully completed GEMINI-1 and GEMINI-2 global Phase 3 trials for GPP, a rare skin disorder affecting between 1.76 and 124 patients per million people worldwide. Vanda plans to prepare BLA and MAA applications for US and EU markets in 2025. AnaptysBio is eligible for up to $35 million in future regulatory and sales milestones, plus a 10% royalty on net sales.
AnaptysBio (ANAB), a clinical-stage biotechnology company specializing in innovative immunology therapeutics, has announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference. Daniel Faga, the company's president and chief executive officer, will deliver a presentation on Tuesday, January 14, 2025, at 4:30 PM PT / 7:30 PM ET.
The presentation will be accessible via live webcast through the investor section of the Anaptys website. Interested parties can access the webcast at http://ir.anaptysbio.com/events, and a replay will remain available for a minimum of 30 days after the event.
AnaptysBio (ANAB) announced that its Phase 2b ARISE-AD trial of ANB032, a BTLA agonist, failed to meet primary and secondary endpoints in treating moderate-to-severe atopic dermatitis. The study involved 201 patients across multiple countries, testing different dosing regimens against placebo. Despite ANB032 showing good tolerability with no safety concerns, the company will discontinue further investment in this asset.
The company will now focus on its remaining autoimmune portfolio, including rosnilimab, with Phase 2b rheumatoid arthritis data expected in February 2025 and Phase 2 ulcerative colitis data in Q1 2026. AnaptysBio maintains a strong financial position with approximately $415 million in cash by year-end 2024, extending their runway through 2027.
AnaptysBio (ANAB) has announced its participation in four major healthcare investor conferences during November and December 2024. The company's president and CEO Daniel Faga, along with senior management, will participate in fireside chats and one-on-one investor meetings at Guggenheim's Healthcare Innovation Conference (Nov. 13), Stifel Healthcare Conference (Nov. 19), Piper Sandler Healthcare Conference (Dec. 3), and Evercore HealthCONx Conference (Dec. 4). Live webcasts will be available on the company's investor website with replays accessible for 30 days after the events.
AnaptysBio reported Q3 2024 financial results and business updates. The company anticipates top-line Phase 2b data for ANB032 in atopic dermatitis in December 2024 and for rosnilimab in rheumatoid arthritis in February 2025. Cash position stands at $458.0 million, with runway through year-end 2026. Q3 collaboration revenue increased to $30.0 million, while net loss was $32.9 million ($1.14 per share). R&D expenses rose to $42.2 million, primarily due to development costs for key pipeline programs. The company initiated a Phase 1 trial for ANB033 and plans to out-license imsidolimab in 2024.
AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on innovative immunology therapeutics, has announced its participation in three upcoming investor conferences in September 2024:
1. 2024 Wells Fargo Healthcare Conference in Boston, MA on Sept. 5 at 10:15am ET
2. Stifel 2024 Virtual Immunology and Inflammation Summit on Sept. 17 at 1:30pm ET
3. 2024 Cantor Fitzgerald Global Healthcare Conference in New York, NY on Sept. 18 at 9:45am ET
The company's president and CEO, Daniel Faga, and/or other senior management team members will participate in fireside chats and one-on-one investor meetings. Live webcasts of the fireside chats will be available on the Anaptys website, with replays accessible for at least 30 days after the events.
AnaptysBio (ANAB) has announced the pricing of an underwritten offering of 2,750,498 shares of common stock at $36.50 per share, a 10% premium to the previous closing price. The offering, led by EcoR1 Capital with participation from existing and new investors including Sanofi, is expected to raise approximately $100 million in gross proceeds. The funds will primarily be used to accelerate Phase 3 trials for ANB032 (BTLA agonist) in atopic dermatitis and rosnilimab (PD-1 agonist) in rheumatoid arthritis and ulcerative colitis. The offering is set to close around August 15, 2024, subject to customary conditions. TD Cowen, Leerink Partners, Piper Sandler, and Guggenheim Securities are acting as joint book-running managers for the offering.
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