Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Belite, Chiesi, Minovia, Transpire.
Biopharma happenings, including deals and partnerships, and other news in brief: Amphista, Apollomics, BMS, Enveric, Gilgamesh, GSK, Insitro, Scisparc, Scynexis.
Antibody-drug conjugate (ADC) specialist Aimedbio Inc. announced Oct. 16 the signing of a potential $991 million deal with Boehringer Ingelheim GmbH to license out its novel preclinical ADC asset targeting solid tumors, including KRAS mutations, which is set to enter phase I study next year.
A year and half from its inception, Adcytherix SAS has raised a €105 million (US$122 million) series A, enabling it to take the lead antibody-drug conjugate (ADC) program into clinical development next year.
Aicuris Anti-Infective Cures AG is preparing to file for U.S. FDA approval after reporting positive phase III results for lead antiviral pritelivir in the healing of refractory herpes simplex virus lesions in immunocompromised patients.
Dianthus Therapeutics Inc. has joined the recent trend of companies licensing therapies in development from China. The company will pay as much as $1 billion to Nanjing Leads Biolabs Co. Ltd. for DNTH-212, a bifunctional BDCA2 and BAFF/APRIL inhibitor to treat autoimmune disorders.
Success by nearly all measures with Praxis Precision Medicines Inc.’s essential tremor phase III candidate, ulixacaltamide, drove the company’s stock up significantly and provided solid data for an NDA filing planned for early 2026.
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