In a deal that could be worth up to $937.5 million, Biogen Inc. licensed rights to phase II-stage, brain-penetrant BTK inhibitor orelabrutinib from Innocare Pharma Ltd. for the treatment of multiple sclerosis (MS) and autoimmune diseases. It’s the first mega out-licensing deal for the Chinese firm, which will receive $125 million up front and is eligible to receive up to $812.5 million in potential development milestones and commercial payments, plus tiered royalties in the low to high teens on potential future net sales. Read More
Brii Biosciences Ltd. raised HK$2.482 billion (US$319 million) in its IPO in Hong Kong and will use the proceeds to support the development of its key assets, which includes programs for hepatitis B virus (HBV), HIV and drug-resistant infections. Read More
Prime Medicine Inc. (PM) likely has “a lock on prime editing technology for therapeutic uses,” CEO Keith Gottesdiener told BioWorld, though research labs are continuing to refine the approach. Cambridge, Mass.-based PM has $315 million in the bank that will help advance the platform, which behaves like a DNA word processor to search and replace disease-causing genetic sequences at their exact location in the genome. Read More
Safety will be the focus July 15 when the FDA’s Cardiovascular and Renal Drugs Advisory Committee dives into the data for Fibrogen Inc.’s roxadustat as a treatment for anemia due to chronic kidney disease. Read More
ISA Pharmaceuticals BV has closed a €26 million (US$30.76 million) funding round to advance its cancer immunotherapy product, ISA-101b, in the clinic, as the company aims to tackle the low response rates that hold back this therapeutic approach. Read More
All the primary endpoints were met in Hepion Pharmaceuticals Inc.’s phase IIa trial of CRV-431 for treating nonalcoholic steatohepatitis (NASH). The market, however, wasn’t celebrating as the Edison, N.J.-based company’s stock (NASDAQ:HEPA) sagged 15.27% on July 13 to close at $1.72 per share. Read More
PERTH, Australia – Following a AU$85 million (US$64.41 million) capital raise, Qbiotics Group Ltd. is progressing its oncology clinical program for lead candidate tigilanol tiglate, a natural product that is isolated from the seed of the Australian rainforest native shrub Fontainea.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alterola, Abti, Aridis, Astellas, Blue Water, Cellectar, Etherna, Evgen, Evrys, Excellthera, Exevir, Heat, Intocell, Legochem, Probiogen. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: AB Science, Antengene, Bayer, Chemocentryx, Coya, Diurnal, Enochian, Gensight, Inotrem, Iveric, Janssen, Kintor, Prilenia, Provention, Seagen, Sigilon, Sirnaomics, Soleno, Tetra, Tevogen, Valneva. Read More