A next-generation Fabry disease treatment may be a step closer to market under a newly revised business strategy revealed by Amicus Therapeutics Inc. The Cranbury, N.J.-based biologics developer unveiled the acquisition of Callidus Biopharma Inc., a corporate restructuring, a $40 million financing and revision of its existing agreement with Glaxosmithkline plc.
With its latest $110 million financing, Moderna Therapeutics Inc. is rapidly closing on the half-billion-dollar mark in terms of funds raised for the 2-year-old company. The new funds bring the company’s total funds raised to $415 million, and it will end the year with about $340 million in the bank.
Topokine Therapeutics Inc. has begun dosing in a Phase II trial of its XAF5 gel for reduction of excess submental fat, or double chin. The product is a formulation of XAF5, which reduces cellular lipid content and differentiation in adipocytes.
Aileron Therapeutics Inc., of Cambridge, Mass., will leverage a new $30 million financing round to advance its lead oncology candidate into the clinic and continue development of its other pipeline products.
Fresh from a special protocol assessment agreement with the FDA, Cell Therapeutics Inc. has snagged a lucrative licensing deal with Baxter International Inc. for its Janus kinase (JAK) inhibitor, pacritinib. The potential $172 million deal gives Baxter exclusive commercialization rights for all indications for pacritinib outside the U.S. The two companies will jointly commercialize the drug within the U.S.
A meeting of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee voted unanimously that Vanda Pharmaceuticals Inc.’s candidate for non-24-hour sleep-wake disorder, Hetlioz (tasimelteon), was safe and voted 10-0, with one abstention, that the company provided substantial evidence of efficacy for the drug.
Briefing documents released ahead of Thursday’s FDA advisory committee meeting regarding Vanda Pharmaceuticals Inc.’s therapy for non-24-hour disorder, tasimelteon, revealed an ongoing disconnect between the sponsor and agency regarding clinical endpoints for the disorder, whose symptoms can be difficult to pin down.
Alnylam Pharmaceuticals Inc. received coveted fast-track designation for its RNAi therapeutic, patisiran, to accelerate its development for treatment of transthyretin (TTR)-familial amyloid polyneuropathy (FAP). The company recently reported positive Phase II results for the product, and has begun a Phase III program.
Novabay Pharmaceuticals Inc. took a pounding in the stock market Thursday after it reported the failure of a Phase IIb study of its impetigo candidate, auriclosene. The study showed that the drug was safe and well tolerated but did not meet the primary clinical endpoint of the trial.
