IMMIX BIOPHARMA DL-,0001 Aktie

FDA RMAT designation follows positive proof-of-concept U.S. clinical data from the NXC-201 NEXICART-2 clinical trial in relapsed/refractory AL Amyloidosis RMAT designation potentially streamlines the path to market approval by allowing frequent interactions with FDA and routes to FDA Accelerated Approval and Priority Review Enrollment in NEXICART-2 study accelerating; next update planned for H1 2025 LOS ANGELES,CA, Feb. 10, 2025 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (Nasdaq: IMMX) (“ImmixBio”, “Company”, “We” or “Us”, “IMMX”), a clinical-stage biopharmaceutical company developing cell therapies for AL amyloidosis and select immune-mediated diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted RMAT designation to sterically-optimized CAR-T NXC-201 for the treatment of relapsed/refractory AL amyloidosis. As of June 2024 public information, FDA approved less than half of RMAT applications submitted to the agency during the last eight years.» Mehr auf globenewswire.com

LOS ANGELES, Jan. 07, 2025 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (Nasdaq: IMMX) (“ImmixBio”, “Company”, “We” or “Us”, “IMMX”), a clinical-stage biopharmaceutical company developing cell therapies for AL Amyloidosis and select immune-mediated diseases, today announced successful completion of the six-patient Phase 1b safety run-in segment in the U.S. NEXICART-2 study of NXC-201, an investigational CAR-T therapy, in patients relapsed/refractory (R/R) AL Amyloidosis. Achievement of this milestone is expected to accelerate enrollment across U.S. study sites beginning in January 2025.» Mehr auf globenewswire.com

All four patients treated with NXC-201 normalized their disease markers within 30 days of dosing, of which, two are already classified as complete responders (CR), and the remaining two are bone marrow MRD negative (10-6); all patients remain in response as of the data cutoff of Nov 14, 2024 Bone marrow MRD negativity predicts future CR; company believes remaining two patients could be confirmed as CRs in the coming weeks and months Company to provide next program update in H1 2025 Conference call to discuss results Dec 19 at 11:00 a.m. ET (link to attend) LOS ANGELES, CA, Dec. 19, 2024 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (“ImmixBio”, “Company”, “We” or “Us” or ”IMMX”), a clinical-stage biopharmaceutical company developing cell therapies for AL Amyloidosis and select immune-mediated diseases, today announced initial clinical data from the first four patients in the ongoing NEXICART-2 (NCT06097832) U.S. study of sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy, NXC-201, in relapsed/refractory AL Amyloidosis.» Mehr auf globenewswire.com