Company Overview - Immix Biopharma, Inc. is a clinical-stage biopharmaceutical company focused on developing cell therapies for AL Amyloidosis and other serious diseases [7] - The lead candidate is NXC-201, a sterically-optimized BCMA-targeted CAR-T cell therapy [4][7] - NXC-201 has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA and Orphan Drug Designation (ODD) from both the FDA and EMA [4][8] Clinical Trials - The NEXICART-2 trial is an ongoing single-arm multi-site U.S. Phase 1/2 clinical trial evaluating NXC-201 in relapsed/refractory AL Amyloidosis, expected to enroll 40 patients with preserved heart function [3] - The primary endpoint of the Phase 1 portion is safety, while the Phase 2 portion focuses on efficacy [3] - Initial data from an ex-U.S. study, NEXICART-1, has shown high complete response rates in relapsed/refractory AL Amyloidosis [4] Market Insights - The U.S. prevalence of relapsed/refractory AL Amyloidosis is estimated to grow at 12% per year, reaching approximately 33,277 patients in 2024 [6] - The amyloidosis market was valued at $3.6 billion in 2017 and is projected to reach $6 billion by 2025 [6] Upcoming Events - Phase 1/2 interim readout data from the NEXICART-2 trial will be presented at the 2025 American Society of Clinical Oncology Annual Meeting in Chicago on June 3, 2025 [1][2] - The presentation will be led by Dr. Heather Landau, Director of the Amyloidosis Program at Memorial Sloan-Kettering Cancer Center [1]

Company Overview - Immix Biopharma, Inc. is a clinical-stage biopharmaceutical company focused on developing cell therapies for AL Amyloidosis and other serious diseases [8] - The lead candidate is NXC-201, a sterically-optimized BCMA-targeted CAR-T cell therapy [5][8] - NXC-201 has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA and Orphan Drug Designation (ODD) from both the FDA and EMA [5][9] Clinical Trials - The ongoing NEXICART-2 trial (NCT06097832) is a single-arm multi-site Phase 1/2 clinical trial evaluating NXC-201 in relapsed/refractory AL Amyloidosis [4] - The trial aims to enroll 40 patients with preserved heart function who have not previously received BCMA-targeted therapy [4] - The primary endpoint for Phase 1 is safety, while for Phase 2 it is efficacy [4] Upcoming Presentation - Interim readout data from the NEXICART-2 trial will be presented at the 2025 American Society of Clinical Oncology Annual Meeting (ASCO 2025) in Chicago [2] - The presentation is scheduled for June 3, 2025, and will be led by Dr. Heather Landau from Memorial Sloan-Kettering Cancer Center [2][3] Market Insights - The U.S. prevalence of relapsed/refractory AL Amyloidosis is estimated to grow at 12% per year, reaching approximately 33,277 patients in 2024 [7] - The amyloidosis market was valued at $3.6 billion in 2017 and is projected to reach $6 billion by 2025 [7]

Wa'el Hashad Wa'el Hashad, CEO, Longeveron MIAMI, April 22, 2025 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions, today announced that the Company’s CEO, Wa’el Hashad, issued the following letter to Longeveron shareholders. Dear Fellow Shareholders, Twenty twenty-four was a year of execution for Longeveron. We made significant progress advancing Longeve ...

Core Insights - FibroBiologics, Inc. is a clinical-stage biotechnology company focused on developing therapeutics and potential cures for chronic diseases using fibroblast cells and materials [1][3] - The company holds over 240 patents issued and pending, covering various clinical pathways including wound healing, multiple sclerosis, disc degeneration, psoriasis, orthopedics, human longevity, and cancer [3] - Hamid Khoja, Ph.D., the Chief Scientific Officer, will present at The Cell & Gene Meeting On The Mediterranean in Rome, highlighting a fibroblast cell-based therapeutic approach targeting chronic inflammation-mediated diseases [1][2] Company Overview - FibroBiologics is based in Houston and represents a new generation of medical advancements in cell therapy and tissue regeneration [3] - The company is actively engaged in the development of a pipeline of treatments aimed at chronic diseases, leveraging its extensive patent portfolio [3] Conference Details - The presentation titled "Restoring Immune system homeostasis using a fibroblast cell-based therapeutic targeting three chronic inflammation-mediated diseases" will take place on April 16, 2025, at 9:00 AM CEST [2] - The event is a significant gathering for the Advanced Therapy Medicinal Products community from Europe and beyond [1][2]

Core Insights - FibroBiologics, Inc. is a clinical-stage biotechnology company focused on developing therapeutics for chronic diseases using fibroblast cells and materials [1][3] - The company holds over 240 patents issued and pending, covering various clinical pathways including wound healing, multiple sclerosis, and cancer [3] - Hamid Khoja, Ph.D., the Chief Scientific Officer, will present at The Cell & Gene Meeting On The Mediterranean, highlighting a fibroblast cell-based therapeutic approach [1][2] Company Overview - FibroBiologics is based in Houston and is engaged in the development of a pipeline of treatments aimed at chronic diseases [3] - The company represents advancements in cell therapy and tissue regeneration, with a focus on innovative medical solutions [3] Conference Details - The presentation titled "Restoring Immune system homeostasis using a fibroblast cell-based therapeutic targeting three chronic inflammation-mediated diseases" will take place on April 16, 2025, at 9:00 AM CEST [2] - The event is a significant gathering for the Advanced Therapy Medicinal Products community in Europe [1][2]

Company Overview - MaxCyte, Inc. is a leading company focused on cell engineering, providing platform technologies to advance the discovery, development, and commercialization of next-generation cell therapeutics [1][3] - The company has over 25 years of expertise in building best-in-class platforms and innovating solutions for the cell therapy market [3] Financial Results Announcement - MaxCyte will release its financial results for the first quarter of 2025 after the U.S. market closes on May 7, 2025 [1] - A conference call to discuss these financial results will be hosted by company management at 4:30 p.m. Eastern Time on the same day [1] Conference Call Registration - Investors interested in the conference call must register online, with a recommendation to do so at least a day in advance [2] - A live and archived webcast of the event will be available on the MaxCyte website [2]

HOUSTON, April 08, 2025 (GLOBE NEWSWIRE) -- FibroBiologics, Inc. (NASDAQ:FBLG) ("FibroBiologics") , a clinical-stage biotechnology company with 240+ patents issued and pending for the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, today announced the opening of a new laboratory facility that will expand the company's ability to pioneer additional candidates for chronic disease-focused indications leveraging its novel fibroblast-based ...

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]

Moderate Alzheimer’s disease (AD) patients in the trial received the highest dose of troculeucel to date at 6 billion cells per treatment. After 12 months of treatment, both patients who completed 17 doses improved from moderate to mild AD within just 3 months. One patient stabilized at their improved score, while the other patient continued to show ongoing improvement. Clinical development of troculeucel is ongoing and will be evaluated for safety and efficacy in the randomized, placebo-controlled Phase 2a ...