The potential for TL1A-targeting duvakitug to impact unmet needs of patients with ulcerative colitis (UC) and Crohn’s disease (CD), and to provide antifibrotic effects for a host of other diseases, boosted shares of Teva Pharmaceutical Industries Ltd. and Sanofi SA by 26.5% and 6.7%, respectively, as the partners released what analysts called “best-in-class” results from the phase IIb Relieve UCCD study and prepare for a phase III trial in 2025.
A year after manufacturing issues resulted in a complete response letter for cosibelimab, the U.S. FDA approved Checkpoint Therapeutics Inc.’s drug, branded Unloxcyt, as the first anti-PD-L1 antibody for use in metastatic or locally advanced cutaneous squamous cell carcinoma patients who are not candidates for curative surgery or curative radiation.
Disappointing readouts from separate phase II studies in atopic dermatitis sank shares of Q32 Bio Inc. and Anaptysbio Inc., as their respective antibody candidates failed to impress in a highly competitive space.
Astria Therapeutics Inc. has gained IND clearance from the FDA for STAR-0310, a monoclonal antibody OX40 antagonist being developed for atopic dermatitis.
Citryll BV has closed an €85 million (US$89.8 million) series B, enabling it to take CIT-013, an antibody designed to block pathological neutrophil extracellular traps that drive a wide range of immune-mediated inflammatory diseases, into phase IIa development.
Researchers from Memorial Sloan Kettering Cancer Center and affiliated organizations revealed findings from the preclinical evaluation of 1H5, a novel monoclonal antibody (mAb) candidate that inhibits the NOTCH signaling pathway and is being developed for the treatment of high-grade gliomas (HGGs).
Autoimmunity Biosolutions has closed a seed financing to support its work advancing a next-generation, immuno-corrective therapy for autoimmune diseases. The company’s approach targets a branch of the interleukin-7 (IL-7)/interleukin-7 receptor (IL-7R) pathway controlled by the soluble IL-7R (sIL-7R), a critical amplifier of autoimmune reactions.
The U.S. FDA added hidradenitis suppurativa to the label for UCB SA’s Bimzelx (bimekizumab-bkzx), throwing renewed light on the indication, a chronic disease that causes painful, boil-like lumps that appear under the skin. Regulators cleared the humanized IL-17A and IL-17F antagonist for adults with moderate to severe HS, marking the drug’s fifth approval.
The EMA has changed its mind about an earlier decision that the risks of Leqembi (lecanemab) outweigh the benefits and is now recommending the Alzheimer’s disease drug is approved for a subgroup of patients. That follows an appeal by Eisai Co. Ltd. and a re-examination of the data, after details relating to 274 patients with two copies of the ApoE4 gene were removed from the file.
RSS
