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.
LONDON – Neuvasq Biotechnologies has launched with a €20 million (US$23.7 million) series A to take forward a new approach to treating neurological disorders by reversing age- or injury-related damage to the blood-brain barrier.
CEO Samantha Singer said Abata Therapeutics Inc. “spent a considerable amount of time finding the right indication” for its approach, which deploys autologous regulatory T cells (Tregs) made to express T-cell receptors (TCRs). That disease is progressive, non-relapsing multiple sclerosis (MS). “We’re going to be able to succeed with these patients where other options have failed,” she told BioWorld.
The FDA authorized marketing of the Portable Neuromodulation Stimulator (Pons) for short-term treatment of gait issues arising from mild to moderate symptoms associated with multiple sclerosis (MS) through its de novo pathway. Helius Medical Inc., a subsidiary of Helius Medical Technologies Inc., makes the non-implantable neuromuscular tongue stimulator.
Now that Johnson & Johnson (J&J), through its Janssen Pharmaceuticals unit, has won the FDA’s nod for Ponvory (ponesimod), market factors will decide how the once-daily oral selective sphingosine-1-phosphate receptor 1 modulator fares against several others already approved in the class.
As it waits on initial data from its two lead programs, in sensorineural hearing loss and multiple sclerosis, Pipeline Therapeutics Inc. raised $80 million in a series C crossover round to progress its pipeline of small-molecule drugs for neuroregeneration and to position it for a potential IPO.
Osmotica Pharmaceuticals plc’s amendment earlier this month to the NDA for arbaclofen in spasticity resulting from multiple sclerosis wasn’t enough to quell the concerns of the FDA, which smacked the firm with its second complete response letter (CRL).
Both phase III studies of ublituximab, an anti-CD20 monoclonal antibody from TG Therapeutics Inc., of New York, met their primary endpoints of significantly reducing the annualized relapse rate in multiple sclerosis (MS) patients. Company stock (NASDAQ:TGTX) received a solid bump Dec. 10 as shares closed 40.85% higher at $41.72. T
Israeli cell therapy specialist Neurogenesis Ltd., said new phase II data has shown that treatment with its autologous cell therapy candidate NG-01 in progressive multiple sclerosis (MS) patients led to an 80% to 90% reduction in disease progression at 12 months compared to a pretreatment period and a 90% reduction in relapses compared to placebo-treated patients.
With a Nov. 6 FDA adcom meeting on Biogen Inc.'s Alzheimer's candidate, aducanumab, creeping ever closer, the candidate's prospects stole the show in its third-quarter earnings report, even outshining attention to the cloud of generics raining on the company's years-long Tecfidera (dimethyl fumarate) parade. FDA acceptance for aducanumab's BLA lines the candidate up for a priority review and regulatory action by March 7, the company said. Furthermore, global progress remains underway, with an EU marketing application now made and one in Japan on deck.
