After selling off amyotrophic lateral sclerosis therapeutics last month, Tanabe Pharma America Inc. emerged a forerunner in another rare disease space with positive top-line phase III data of dersimelagon (MT-7117) for erythropoietic protoporphyria/X-linked protoporphyria.

Immunofoco Biotechnology Co. Ltd. reported encouraging early clinical data for its CLDN18.2-targeted CAR T therapy, IMC-002, in heavily pretreated gastric and gastroesophageal junction cancer, adding momentum to the push to extend cellular immunotherapy into solid tumors.

Takeda Pharmaceuticals Co. Ltd.’s oral tyrosine kinase 2 inhibitor, zasocitinib (TAK-279), met the co-primary endpoints and all ranked secondary endpoints in two pivotal phase III studies in patients with moderate to severe plaque psoriasis.

BioWorld logged 170 clinical trial updates across phases I through III in November 2025, a decline from 252 updates in October and 230 in September, but higher than the 95 reported in August.

Daiichi Sankyo Inc. told BioWorld it voluntarily placed a partial hold in recruitment and enrollment in the phase III IDeate-Lung02 study of antibody-drug conjugate ifinatamab deruxtecan because of a higher than anticipated incidence of grade 5 interstitial lung disease events. The company did not say how many deaths there had been.

Radiopharm Theranostics Ltd.’s radiotracer RAD-101 met the primary endpoint in 92% of patients in the phase IIb imaging trial in brain metastases, according to interim results. To date, 11 of the 12 patients treated with RAD-101 (F18-Pivalate) achieved concordance with MRI (the primary endpoint) as assessed by PET imaging of brain metastases. The results showed significant and selective tumor uptake, and images confirm metabolic activity in brain metastases compared to equivocal MRI findings.

China’s clinical trial volume has surged to nearly U.S. scale and now tops Europe, sitting at about 80% of U.S. levels and roughly 10% above the EU in 2024.

Hightide Therapeutics Inc.’s berberine ursodeoxycholate (HTD-1801) met the primary endpoint showing superior improvements in key cardiometabolic markers in patients with type 2 diabetes compared to Astrazeneca plc’s SGLT2 inhibitor, Farxiga (dapagliflozin), in a head-to-head phase III trial.

Myrio Therapeutics Pty Ltd. has been able to accomplish something no other company has yet been able to crack: to develop binders where both the affinity and the specificity can be increased.