Rise Therapeutics LLC has received FDA clearance for its IND application to proceed with a phase I trial of R-3750, a synthetic biology-based cellular immunotherapy being developed for the treatment of inflammatory bowel disease. The phase I trial will enroll patients with mild to moderate ulcerative.

The U.S. FDA has lifted the clinical hold on Astellas Pharma Inc.’s Fortis phase I/II trial evaluating AAV gene replacement therapy AT-845 in adults with late-onset Pompe disease.

Deka Biosciences Inc.'s IND application has been cleared by the FDA allowing the company to proceed with a phase I trial of DK-210 (EGFR) in patients with advanced solid cancer overexpressing epidermal growth factor receptors (EGFR).

Winning the race to market with the first oral selective estrogen receptor degrader (SERD) for breast cancer is Menarini Group’s elacestrant, which gained U.S. FDA approval for use as second- and third-line therapy in patients with ER-positive/HER2-negative advanced or metastatic disease with the ESR1 mutation. It marks the first therapy approved specifically targeting ESR1, found in up to 40% of patients with ER-positive/HER2-negative disease.

Mantle cell lymphoma (MCL) patients developing resistance to existing BTK inhibitors now have a new treatment option, with the U.S. FDA’s accelerated approval of Jaypirca (pirtobrutinib) from Eli Lilly and Co.’s oncology unit, Loxo@Lilly. It is indicated for use in adults with relapsed or refractory disease who have received at least two lines of systemic therapy, including a BTK inhibitor.

Centessa Pharmaceuticals plc has received clearance of its IND application from the FDA to initiate a first-in-human phase I/IIa trial of LB-101 for the treatment of solid tumors.