The U.S. FDA named the first nine recipients of the recently unveiled commissioner’s national priority voucher (CNPV) program aimed at addressing unmet public health needs by shortening regulatory review times to as little as one to two months. For one of those firms, Disc Medicine Inc., which submitted an NDA for bitopertin for rare genetic disorder erythropoietic protoporphyria in September, that could mean a potential approval before the end of 2025.
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.
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