The U.K. Medicines and Healthcare products Regulatory Agency is calling for unified standards to harmonize microbiome research, after revealing major inconsistencies in the results when labs around the world analyzed identical reference samples of gut bacteria.

Radiopharm Theranostics Ltd. has been granted Bellberry Human Research Ethics Committee (HREC) approval in Australia to initiate a first-in-human phase I trial of its KLK3-targeting radiotherapeutic, RAD-402, for the treatment of metastatic or locally advanced prostate cancer.

T-knife Therapeutics Inc. has filed a clinical trial application (CTA) to initiate a phase I trial of TK-6302, a PRAME-targeted T-cell receptor (TCR) T-cell therapy in solid tumors. Pending CTA approval, the ATLAS trial is planned to begin next year.

Akeso Inc. has received clearance from China’s National Medical Products Administration (NMPA) to initiate clinical trials with AK-152 for Alzheimer’s disease.

Evotec SE has received a $5 million milestone payment from Bristol Myers Squibb Co. (BMS), following the acceptance of an IND application by the FDA in the companies’ strategic protein degradation partnership.

Leukogene Therapeutics Inc.’s lead product candidate LTI-214 (M2T-CD33) has been awarded orphan drug designation by the FDA for the treatment of acute myeloid leukemia (AML).

The U.S. FDA has granted orphan drug designation to Dewpoint Therapeutics Inc.’s DPTX-3186, its first-in-class condensate modulator for the treatment of gastric cancer. The designation follows the recent opening of Dewpoint’s IND application for DPTX-3186 earlier in October, and is the first orphan designation ever granted to a condensate-modulating therapeutic.

Exousia Pro Inc.’s subsidiary, Exousia AI, has received orphan drug designation from the FDA for its exosome-based treatment for malignant glioma.

Microbiotix Co. Ltd. has obtained IND approval from the Korean Ministry of Food and Drug Safety (MFDS) for MP-101, a bacteriophage therapy for patients with acute pneumonia. A phase I study in adult patients with Pseudomonas aeruginosa-induced pneumonia is expected to enroll its first patient within the year.

CSPC Pharmaceutical Group Ltd. has obtained clearance from China’s National Medical Products Administration (NMPA) to conduct clinical trials with SYH-2061 injection for the treatment of IgA nephropathy and other complement-mediated diseases.