Shares of Corbus Pharmaceuticals Inc. (NASDAQ:CRBP) doubled on opening Jan. 26 and ended the day up a whopping 249% as investors got a look at data from a first-in-human study testing next-generation Nectin-4-targeted antibody-drug conjugate (ADC) CRB-701. Licensed from CSPC Pharmaceutical Group for $7.5 million up front in February 2023, CRB-701 has IND clearance from the U.S. FDA, and Corbus plans to start its own clinical testing in the first quarter of 2024. Read More
After almost 10 years on the market, the EMA is to withdraw its conditional approval of the Duchenne muscular dystrophy treatment Translarna (ataluren), after concluding there is still not enough evidence of its effectiveness. Read More
Seoul-based Genexine Inc. filed a BLA to gain domestic approval of its follow-on biologic for chronic kidney disease (CKD)-induced anemia, Efesa (efepoetin alfa, GX-E4), to South Korean health regulators on Jan. 25. Read More
Oncology company Arrivent Biopharma Inc.’s stock (NASDAQ:AVBP) shot up 11% on Jan. 26, its first day of trading, with its upsized IPO pricing 9.72 million shares at $18 each, raising gross proceeds of $175 million. Read More
Becoming the first treatment for children ages 1 to 11 with eosinophilic esophagitis (EE), Sanofi SA and Regeneron Pharmaceuticals Inc.’s IL-4/IL-13 inhibitor Dupixent (dupilumab) was cleared by the U.S. FDA on Jan. 25. Read More
For full year 2023, clinical trial updates saw a 5.23% increase compared to the corresponding period last year. In December, BioWorld tracked 281 phase I-III clinical trial updates, a decline from the 354 noted in November and 416 reported in October. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aulos, Biosenic, Breye, Exelixis, Fibrogen, G.ST, Panbela, Processa and Vera. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Newcourt, Psyence, Renalys, Travere. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ocular Therapeutix. Read More
