Tag: therapy

BRUSSELS and CAMBRIDGE, Mass., June 12, 2025 (GLOBE NEWSWIRE) -- UCB (Euronext Brussels: UCB) and Biogen Inc. (NASDAQ: BIIB) today presented additional detailed results from the Phase 3 PHOENYCS GO study evaluating dapirolizumab pegol (DZP), a novel Fc-free anti-CD40L drug candidate. In the study, DZP demonstrated significant clinical improvements in disease activity in people living with moderate-to-severe systemic lupus erythematosus (SLE), as measured by the British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) at Week 48, the primary endpoint. Improvements were also seen across additional clinical measures, including fatigue and disease activity/remission. These results were presented at EULAR 2025, the European Alliance of Associations for Rheumatology’s annual meeting, in Barcelona, Spain. The safety and efficacy of DZP in SLE have not been established, and it is not approved for use in SLE by any regulatory authority worldwide. A second Phase 3 trial of dapirolizumab pegol is ongoing with the goal of confirming the results from PHOENYCS GO.

NEW YORK, June 11, 2025 (GLOBE NEWSWIRE) -- Mesoblast (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an update on continued momentum with United States Food and Drug Administration (FDA) regarding both accelerated approval pathway for Revascor^® (rexlemestrocel-L) in the treatment of patients with ischemic chronic heart failure with reduced ejection fraction (HFrEF) and inflammation, and label extension for Ryoncil^® (remestemcel-L-rknd) in adults with steroid refractory acute graft versus host disease (SR-aGvHD).

OCALA, Fla., June 11, 2025 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (OTC Pink: AIMID) (NYSE American: AIM) (“AIM” or the “Company”) today announced a reverse stock split (“Reverse Stock Split”) of its shares at a ratio of 1-for-100. The Reverse Stock Split will take effect at market open tomorrow, June 12, 2025. The Company’s ticker symbol on the OTC Pink will be AIMID for 20 trading days, including the effective date.

WOBURN, Mass., June 11, 2025 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI), a biopharmaceutical company focused on the development and commercialization of photodynamic therapy (PDT), confirms a disclosure by the Management Board of Biofrontera AG on June 10, 2025, according to which the two companies are in negotiations regarding a possible combination of the two companies or an adjustment of the license and supply agreement between them. The latter could result in the transfer of certain rights and obligations from Biofrontera AG to Biofrontera Inc. and a reduction in the transfer price for Biofrontera Inc.’s licensed products sold in the US.