$25 Million Funded at Close to Refinance Existing Debt and Extend Maturity Additional Borrowing Capacity Provides Minimally Dilutive Growth Capital CARLSBAD, Calif., April 28, 2025 (GLOBE NEWSWIRE) -- Exagen Inc. (Nasdaq: XGN), a leading provider of autoimmune testing solutions, today announced it has entered into an agreement with Perceptive Advisors LLC for a term loan credit facility of up to $75 million, with $25 million funded at closing to retire an existing debt facility and strengthen the balance sh ...

Core Viewpoint - The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of VYVGART® (efgartigimod alfa) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) in adult patients, marking a significant advancement in treatment options for this rare autoimmune disease [1][4]. Company Overview - argenx SE is a global immunology company focused on developing innovative treatments for severe autoimmune diseases, aiming to address significant unmet medical needs [2][9]. - The company has developed VYVGART, the first targeted IgG Fc-antibody fragment for CIDP, which, if approved, would be the first novel treatment for CIDP in Europe in over 30 years [2][5]. Clinical Trial Insights - The CHMP recommendation is based on positive results from the ADHERE clinical trial, which is the largest study of CIDP patients to date, involving 322 participants [3][5]. - In the ADHERE trial, 66.5% of patients treated with VYVGART showed clinical improvement, with a primary endpoint met demonstrating a 61% reduction in the risk of relapse compared to placebo [3][5]. - The trial also indicated significant functional improvements in various clinical assessment tools, with 99% of participants opting to continue in the open-label extension of the study [3][5]. Market Implications - The CHMP's positive opinion serves as a scientific recommendation for marketing authorization, with the European Commission expected to make a decision within approximately two months [4][5]. - If approved, VYVGART will be available for subcutaneous injection, providing a new treatment option for CIDP patients across all 27 EU member states, as well as Iceland, Norway, and Liechtenstein [4][5]. Disease Context - CIDP is a rare autoimmune disease affecting the peripheral nervous system, leading to symptoms such as fatigue, muscle weakness, and loss of sensation, which can significantly impair daily functioning [7]. - There are an estimated 31,413 individuals living with CIDP in the European Union, highlighting the need for effective treatment options [7].

Partnership bolsters Boehringer's autoimmune and inflammatory disease pipeline portfolio aiming to tackle areas of high unmet patient need.The agreement focuses on further research and development of a novel, first-in-class bispecific compound for T cell mediated targeted depletion of specific B cells to address autoimmune and inflammatory diseases.The candidate compound has the potential to reach patients with autoimmune diseases earlier in their treatment journey and achieve long-term disease control by r ...

Core Insights - Artiva Biotherapeutics has appointed Dr. Subhashis Banerjee as Chief Medical Officer, enhancing its development team focused on autoimmune diseases and cell therapy [1][2] - Dr. Banerjee has over 20 years of clinical development experience, previously holding significant roles at Bristol Myers Squibb and VYNE Therapeutics [1][2] - The company aims to advance its AlloNK® program for treating B-cell driven autoimmune diseases, leveraging Dr. Banerjee's expertise in regulatory approval of major therapies [2][5] Company Overview - Artiva Biotherapeutics is a clinical-stage biotechnology company dedicated to developing safe and effective cell therapies for autoimmune diseases and cancers [5][6] - The lead program, AlloNK®, is a non-genetically modified NK cell therapy designed to enhance the efficacy of monoclonal antibodies for B-cell depletion [5] - Artiva was founded in 2019 as a spin-out from GC Cell, holding exclusive rights to NK cell manufacturing technology outside of Asia, Australia, and New Zealand [5] Recent Appointments - Dr. David Moriarty has been appointed as SVP of Clinical Operations, bringing nearly 25 years of experience in clinical research related to cell therapy and autoimmune diseases [3][4] - Benjamin Dewees has joined as SVP of Regulatory Affairs, with over 25 years of experience in regulatory affairs across various therapeutic areas [9] - Feng Xu has been appointed as SVP of Biometrics, contributing over 20 years of clinical development experience, including successful global regulatory filings [9]

Core Insights - Cartesian Therapeutics announced positive 12-month efficacy and safety data from the Phase 2b trial of Descartes-08 for generalized myasthenia gravis (MG), showing sustained symptom improvement in participants [2][4][9] - Descartes-08 demonstrated a significant average reduction in MG-ADL scores, particularly in patients without prior biologic therapy, indicating its potential as a transformative treatment option [9][11] Efficacy Results - Participants treated with Descartes-08 experienced an average MG-ADL reduction of 4.8 points at Month 12, with deeper responses observed over time [7][11] - In the subgroup of participants without prior biologic therapy, the average MG-ADL reduction was 7.1 points at Month 12, with 57% maintaining minimum symptom expression [11] - 83% of evaluable participants maintained a clinically meaningful response through Month 12, defined as a reduction of at least 2 points in MG-ADL [7] Safety Profile - The safety profile of Descartes-08 was consistent with previously reported data, supporting its outpatient administration without the need for preconditioning chemotherapy [4][10] - Adverse events were mostly mild and transient, with no new adverse events reported during the 12-month follow-up [10][11] Future Development - The Phase 3 AURORA trial is on track to dose the first patient in the second quarter of 2025, with the trial design accepted by the FDA under the Special Protocol Assessment process [9][14] - Descartes-08 has received Regenerative Medicine Advanced Therapy and Orphan Drug Designations from the FDA, highlighting its potential in treating MG [9][13]

Core Insights - Cartesian Therapeutics announced positive 12-month efficacy and safety data from the Phase 2b trial of Descartes-08 for generalized myasthenia gravis (MG) [2][4] - Descartes-08 demonstrated sustained symptom improvement with an average reduction of 4.8 points in MG Activities of Daily Living (MG-ADL) at Month 12 [6][8] - The therapy showed particularly strong results in participants without prior exposure to biologic therapies, achieving an average 7.1-point reduction in MG-ADL [10] Efficacy Results - In the Phase 2b trial, participants receiving Descartes-08 experienced deep responses, with an average MG-ADL reduction of 5.5 at Month 4 and 4.8 at Month 12 [6][4] - 83% of evaluable participants maintained a clinically meaningful response through Month 12, defined as a reduction of at least 2 points in MG-ADL [6] - Among participants without prior biologic therapy, 100% maintained a clinically meaningful response through Month 12 [10] Safety Profile - Descartes-08 was well-tolerated, with no new adverse events reported during the 12-month follow-up [10] - Common side effects included transient infusion-related reactions such as fever (60%), chills (60%), headache (55%), and nausea (45%), all resolving within 24 hours [10] - No cases of cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) were reported [10] Future Developments - The Phase 3 AURORA trial is set to dose the first patient in the second quarter of 2025, following FDA agreement on the trial design [8][10] - Descartes-08 has received Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug Designations from the FDA for the treatment of MG [12][8] - The company aims to transform the treatment landscape for MG with Descartes-08, offering a safe and durable outpatient therapy option [8][10]

Kezar Life Sciences (KZR) Q4 2024 Earnings Call March 25, 2025 08:00 AM ET Company Participants Christopher Kirk - CEO & Co-FounderCraig Lammert - Associate Professor of MedicineGideon Hirschfield - ProfessorMatt Phipps - Group Head - Biotechnology Conference Call Participants Divya Rao - AnalystMaury Raycroft - Equity Research AnalystDerek Archila - AnalystMitchell Kapoor - Director, Senior Biotechnology Analyst Operator Good day, everyone. My name is Shell, and I will be your conference operator today. At ...

Nektar Therapeutics (NKTR) Q4 2024 Earnings Call March 13, 2025 01:38 AM ET Company Participants Vivian Wu - Director of Investor Relations & Corporate AffairsHoward W. Robin - CEO, President & DirectorBrian Kotzin - Interim Chief Medical OfficerJonathan Zalevsky - Senior VP & Chief Research and Development OfficerSandra Gardiner - Chief Financial OfficerJulian Harrison - Managing DirectorMayank Mamtani - Senior Managing Director Conference Call Participants Yasmeen Rahimi - Sr. Research AnalystJay Olson - ...

Core Insights - Q32 Bio Inc. announced the presentation of Phase 2a Part A results of bempikibart for alopecia areata at the 2025 AAD Annual Meeting, highlighting its potential in treating severe cases of the disease [1][2] Group 1: Clinical Trial Details - The SIGNAL-AA Phase 2a clinical trial is a randomized, placebo-controlled study evaluating bempikibart, a fully human anti-IL-7Rα antibody [1][4] - The oral presentation will take place on March 8, 2025, from 10:36 a.m. to 10:48 a.m. ET at Chapin Theater, Level II [2] Group 2: Company Overview - Q32 Bio is a clinical stage biotechnology company focused on developing biologic therapeutics aimed at restoring immune homeostasis in autoimmune and inflammatory diseases [3][4] - Bempikibart is being evaluated for its ability to re-regulate adaptive immune function by blocking IL-7 and TSLP signaling pathways, which are implicated in various autoimmune diseases [4]

Core Insights - Q32 Bio Inc. is a clinical stage biotechnology company focused on developing biologic therapeutics to restore immune homeostasis [1][2] - The company will participate in two investor conferences in March 2025, providing opportunities for engagement with investors [1] Company Overview - Q32 Bio targets potent regulators of the adaptive immune system to address autoimmune and inflammatory diseases [2] - The company is advancing bempikibart (ADX-914), a fully human anti-IL-7Rα antibody, currently in a Phase 2 program for the treatment of autoimmune diseases [3] Upcoming Events - Q32 Bio will present at the TD Cowen 45th Annual Health Care Conference on March 5, 2025, at 11:50 a.m. E.T. in Boston, MA [1] - The company will also participate in the Leerink Partners Global Healthcare Conference on March 11, 2025, with a fireside chat at 11:20 a.m. E.T. in Miami Beach, FL [1] - Webcasts of the presentations will be available on the company's website, with archived replays for 90 days [1]