Biogen
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RayThera will bring three preclinical assets into the Biogen fold, all with anti-inflammatory activity. The most mature of these assets is expected to enter Phase 1 development in Q3.
Biopharmas that announced Series B financing this year and are looking for employees as they grow include two companies that received $100 million or more. One has partnerships with three Big Pharmas.
Biogen and Denali’s Parkinson’s disease drug failed to significantly slow disease progression in a Phase 2b study, missing both primary and secondary endpoints.
If Biogen has shown that tau can impact cognition, Denali’s technology—validated with an FDA approval in Hunter syndrome—could ensure the medicine gets where it needs to be for the greatest therapeutic impact, analysts said.
While Biogen’s tau-targeting therapy didn’t demonstrate improvement on a dementia severity scale, the company touted biomarker and cognitive improvements from the Phase 2 study, leaving analysts eager for more data.
The FDA’s extension will give reviewers more time to review a major amendment to Biogen and Eisai’s application for a subcutaneous induction formulation of Alzheimer’s therapy Leqembi. The new target action date is on Aug. 24.
The FDA is looking at a slew of label expansions this month, including one that could open up home-based treatments for Alzheimer’s disease.
Biogen’s growth was expected to stay flat through the 2030s. A key acquisition and busy late-stage pipeline have relieved the pressure and cleared the way for some early-stage bets, CEO Chris Viehbacher said Wednesday.
Key dosing differences between Eli Lilly’s Kisunla and Biogen’s Leqembi are about to come to a head in the Alzheimer’s market as patients end their 18-month course of Lilly’s product.
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