In a deal that could bring the company as much as $1.04 billion, Arrowhead Pharmaceuticals Inc. will collaborate with Takeda Pharmaceutical Co. Ltd. to co-develop and co-commercialize an investigational RNAi-based liver disease treatment. Arrowhead’s candidate, ARO-AAT, is designed to reduce mutant alpha-1 antitrypsin protein production, which causes the disease to progress. Arrowhead will receive a $300 million up-front payment on closing in addition to development, regulatory and commercial milestones that could total $740 million.
The regulatory path for Saniona AB’s Tesomet for treating two rare eating disorders, Prader-Willi syndrome (PWS) and hypothalamic obesity, continues to be a winding one with surprises along the way. The newest twist is pre-IND feedback from the FDA that knocked the stock down 10.5% on Oct. 9.
Janpix Inc., of Cambridge, Mass., has raised a $10 million series B designed to progress its monovalent small-molecule protein degraders of STAT3 and STAT5 into final preclinical studies and eventually into the clinic to treat various hematological and solid tumor cancers.
In a deal that could bring the company as much as $1.04 billion, Arrowhead Pharmaceuticals Inc. will collaborate with Takeda Pharmaceutical Co. Ltd. to co-develop and co-commercialize an investigational RNAi-based liver disease treatment. Arrowhead’s candidate, ARO-AAT, is designed to reduce mutant alpha-1 antitrypsin protein production, which causes the disease to progress. Arrowhead will receive a $300 million up-front payment on closing in addition to development, regulatory and commercial milestones that could total $740 million.
Federation Bio Inc., which just closed a $50 million series A, had enough preclinical data in engineering bacteria to drive the immune system up or down that it actually could have become two separate companies, its new CEO told BioWorld.
Pharmacyte Biotech Inc. is now in a series of 30-day cycles with the FDA as a planned phase IIb study of its lead candidate has been placed on hold. On Sept. 2, Pharmacyte submitted its IND for a phase IIb trial of its product, known as Cypcap, in locally advanced, inoperable pancreatic cancer and, on Oct. 2, the company said the FDA placed the application on hold.
Both Solid Biosciences Inc. and Pfizer Inc. got lifts to their Duchenne muscular dystrophy (DMD) programs from the FDA as the agency released a clinical hold and awarded a fast track designation to their respective adeno-associated viral (AAV) programs.
With a just-completed $100 million common stock financing, Flame Biosciences Inc. plans to target the inflammasome, a protein complex that sets off innate immune responses by activating the cytokines IL-1beta and IL-18.
The aging portfolios of drug companies and the emergence of China as it moves to develop more innovative therapies are two signposts from an industry in flux, according to the newly released 2020 Centre for Medicines Research (CMR) International Pharmaceutical R&D Factbook.