APEX Part A met all primary and key secondary endpoints and exceeded trial objectives, including 71.0% decrease from baseline in EASI at Week 16 APG777 demonstrated EASI-75 of 66.9% (42.5% placebo-adjusted) at Week 16, the highest topline and placebo-adjusted efficacy of any biologic in a global study Exposure-response relationship observed across multiple key endpoints; APEX Part B is testing higher exposures with readout accelerated and now anticipated mid-2026, enabling planned Phase 3 initiation in 2026 ...

APEX Part A met all primary and key secondary endpoints and exceeded trial objectives, including 71.0% decrease from baseline in EASI at Week 16 APG777 demonstrated EASI-75 of 66.9% (42.5% placebo-adjusted) at Week 16, the highest topline and placebo-adjusted efficacy of any biologic in a global study Exposure-response relationship observed across multiple key endpoints; APEX Part B is testing higher exposures with readout accelerated and now anticipated mid-2026, enabling planned Phase 3 initiation in 2026 ...

Company Overview - Apogee Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing novel biologics for inflammatory and immunology (I&I) markets, targeting conditions such as atopic dermatitis (AD), asthma, eosinophilic esophagitis (EoE), and chronic obstructive pulmonary disease (COPD) [3] - The company aims to overcome limitations of existing therapies by utilizing advanced antibody engineering to optimize properties like half-life, with a focus on achieving best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies [3] Upcoming Events - Apogee Therapeutics will report Part A 16-week data from the Phase 2 APEX trial of its lead program APG777 on July 7, 2025, followed by a conference call and webcast at 8:00 a.m. ET to discuss the results [1][2] Product Pipeline - APG777 is the most advanced program of Apogee, initially developed for the treatment of atopic dermatitis, which is identified as the largest and one of the least penetrated I&I markets [3] - The company has four validated targets in its portfolio, indicating a broad pipeline and depth of expertise aimed at delivering value and meaningful benefits to patients underserved by current standard care [3]

Key Takeaways AbbVie is acquiring Capstan Therapeutics for up to $2.1B to expand its immunology portfolio. The acquisition adds CPTX2309, a phase I in vivo CAR-T therapy for autoimmune diseases, to AbbVie's pipeline. Capstan's CellSeeker tLNP platform enables RNA delivery to engineer specific cell types inside the body.AbbVie (ABBV) announced that it has entered into a definitive agreement to acquire privately held biotech, Capstan Therapeutics, for up to $2.1 billion in cash.The impending acquisition wil ...

Phase 1b study supports proof-of-concept in DOK7 congenital myasthenic syndromes Decision informed by favorable safety profile and consistent functional improvement over time across multiple efficacy measures Advancing ARGX-119 further validates strong track record of Immunology Innovation Program (IIP), argenx's collaborative discovery model June 30, 2025, 7:00 AM CET Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people ...

Corporate Presentation May 2025 1 FLS This presentation contains forward-looking statements within the meaning of applicable securities laws and regulations including, but not limited to, statements regarding: the expected timing of receipt of topline results from the navenibart ALPHA-ORBIT Phase 3 trial; the goals and objectives of the ALPHA-ORBIT Phase 3 trial and the ORBIT-EXPANSE long-term trial, including that they are designed to support registration of Q3M and Q6M navenibart administration; the expec ...

Apellis Pharmaceuticals (APLS) FY 2025 Conference June 11, 2025 10:40 AM ET Speaker0 Good morning, everyone. Thank you so much for joining us. I'm Salveen Richter, Biotechnology Analyst at Goldman Sachs, and I'm really pleased to have with us today the Apellis team. Sitting next to me is Cedric Francois, CEO, Co Founder and President. Next to him is David Achleson, Head of Global Commercial and then Tim Sullivan, CFO. To start here, before we dive into specifics, can you just provide us a snapshot of your b ...

Summary of Biogen Thematic Pipeline Seminar on Rare Kidney Disease Company and Industry Overview - **Company**: Biogen - **Industry**: Rare Kidney Disease and Nephrology Core Points and Arguments 1. **Focus on Falzartamab**: The seminar centers on Biogen's drug falzartamab and its potential across multiple nephrology indications, particularly in rare kidney diseases [3][4] 2. **Restructuring for Growth**: Biogen has restructured its business through the "fit for growth" program, leading to the launch of four disease-modifying treatments in the past two years, which now contribute significantly to total revenue [5][6] 3. **Pipeline Diversification**: The company has critically reviewed its development assets, resulting in a more diversified and promising pipeline, particularly in immunology and nephrology [6][7] 4. **Immunology Expansion**: The acquisition of Hibio has accelerated Biogen's expansion into immunology, with three phase three studies in rare nephrology indications currently being initiated [7][8] 5. **Unique Mechanism of Action**: Falzartamab targets CD38, which is believed to be effective in treating antibody-mediated diseases by depleting cells that produce autoantibodies, potentially offering a differentiated safety profile [15][16] 6. **Clinical Data for AMR**: In a phase two study for antibody-mediated rejection (AMR), over 80% of patients showed resolution of AMR features on biopsy, compared to 20% in the placebo group, indicating falzartamab's potential as a breakthrough therapy [27][28] 7. **High Unmet Need in AMR**: AMR is a leading cause of kidney transplant failure, with no approved treatments currently available, highlighting the significant opportunity for falzartamab [21][22] 8. **Cost Implications**: The cost to treat AMR is approximately $160,000 per year, emphasizing the economic burden and the need for effective therapies [23] 9. **Phase Three Study for AMR**: The TRANSCEND phase three study will enroll around 120 kidney transplant recipients with late AMR, with results expected in 2027 [30][31] 10. **IgA Nephropathy (IGAN)**: IGAN is the most common type of primary glomerulonephritis, and falzartamab has shown promise in reducing proteinuria and maintaining kidney function over time [53][60] 11. **Phase Three Study for IGAN**: The PREVAIL phase three study is underway, with data expected in 2029, focusing on the change in proteinuria and eGFR [61][62] 12. **Primary Membranous Nephropathy (PMN)**: PMN is characterized by severe antibody-mediated disease with no approved treatments, and falzartamab has shown robust reductions in anti-PLA2R antibodies in clinical studies [83][89] 13. **Phase Three Study for PMN**: The PROMINENT phase three study is set to confirm the efficacy of falzartamab in moderate to high-risk patients with PMN, with results expected in 2029 [90][91] Other Important but Possibly Overlooked Content 1. **Commercial Potential**: Each of the three indications (AMR, IGAN, PMN) presents significant commercial potential, despite varying patient populations and market sizes [110][111] 2. **Chronic Dosing Considerations**: The potential for chronic dosing in AMR and the need for ongoing treatment in PMN and IGAN are critical factors in the commercialization strategy [111][112] 3. **Future Opportunities**: Biogen is exploring additional indications for falzartamab, including lupus nephritis, with a phase one study expected to provide data by 2026 [114][115] This summary encapsulates the key points discussed during the Biogen thematic pipeline seminar, focusing on the company's strategic direction, clinical advancements, and the potential impact of falzartamab in treating rare kidney diseases.

Kymera Therapeutics (KYMR) FY Conference June 10, 2025 03:20 PM ET Speaker0 Hi, Speaker1 everyone. Good afternoon. Thanks so much for joining us. I'm Andrea Newkirk, one of the biotech analysts here at GS. And I'm really pleased to be joined by Nella Manolfe, founder, president, and CEO of Chimera. Thanks so much. Speaker0 Thanks for having us. Speaker1 Yeah, of course. So maybe before we dig into the data that you just presented last week for your STAT6 program, I thought maybe we could start with a overvi ...

Company to host webcast on Thursday, June 12 at 6:00 pm ETHAMPTON, N.J., June 10, 2025 (GLOBE NEWSWIRE) -- Celldex (NASDAQ:CLDX) announced today that data from the Company’s Phase 2 study of barzolvolimab in chronic spontaneous urticaria will be presented at the EAACI Congress 2025 being held in Glasgow, Scotland. Abstracts will be available on the meeting website Thursday, June 12th at 6:01 pm ET/ Friday, June 13th at 12:01 am CEST. Celldex will host a webcast on Thursday, June 12th at 6:00 pm ET to discus ...