China Medical System Holdings Ltd. has received clinical trial approval from China’s National Medical Products Administration (NMPA) for CMS-D008 injection for overweight or obese individuals.
Great Novel Therapeutics Biotech & Medicals Corp.’s epigenetic immunoactivator, GNTbm-38, has received IND clearance from the FDA, enabling initiation of a phase I trial in the U.S.
Kestrel Therapeutics Inc. has obtained IND approval from the FDA for KST-6051, an oral, small-molecule pan-KRAS inhibitor being developed for the treatment of KRAS-driven cancers.
Sanaregen Vision Therapeutics Inc. has received FDA clearance to conduct a phase I/II trial of SVT-001, an investigational cell therapy for individuals with familial drusen.
Gubra A/S has announced the submission in Germany of a clinical trial application (CTA) for a first-in-human study of GUB-UCN2, the company’s lead asset for weight loss. The planned phase I/IIa trial will enroll both healthy volunteers and individuals with obesity, with and without related co-morbidities. GUB-UCN2 is expected to enter clinical development in the first half of this year.
CF Pharmtech Inc. has announced approval from China’s National Medical Products Administration (NMPA) of an IND application filed by subsidiary Changfeng Suyue Pharmaceutical (Guangzhou) Co. Ltd. for ICF-004.
Kivu Bioscience Inc. has announced receipt of Human Research Ethics Committee approval and clinical trial notification clearance in Australia to initiate a first-in-human trial of KIVU-305, its CEACAM5-targeted antibody-drug conjugate.
Tessera Therapeutics Inc.’s lead in vivo gene editing program, TSRA-196, has been awarded orphan drug and fast track designations by the FDA for adults with α-1 antitrypsin deficiency (AATD).
Zelluna ASA has received approvals from the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) and research ethics committee for its clinical trial application (CTA) for ZI-MA4-1, Zelluna’s lead T-cell receptor-based natural killer (TCR-NK) product candidate.
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