Takeda has terminated a neuro partnership with Denali Therapeutics as the Japanese pharma undergoes a massive restructuring marked by significant layoffs.
Takeda has handed back a dementia candidate called DNL593 to Denali, according to an April 3 filing with the Securities and Exchange Commission.
The companies originally teamed up in 2018 to co-develop up to three new drugs for neurodegenerative diseases. Takeda later took up an option on that deal for an Alzheimer’s prospect, but after the FDA poopooed the partners’ clinical plans, the duo scrapped the asset.
With the DNL593 deal torn up, Denali has no further partnered assets or collaborations with Takeda, a Denali spokesperson confirmed to Fierce Biotech.
Takeda’s decision to return DNL593 was entirely strategic and not due to safety or efficacy concerns, according to the filing.
“We’re pleased to regain full ownership of DNL593 and look forward to advancing this investigational therapy for the treatment of frontotemporal dementia-granulin (FTD-GRN) independently,” the Denali spokesperson told Fierce. “We plan to report results from the ongoing phase 1/2 trial of DNL593 by the end of 2026.”
That trial is a randomized, placebo-controlled study with 85 participants enrolled. Forty of these participants have FTD-GRN, and DNL593 has so far shown signs that it can reach the brain with no serious safety signals, according to an April 3 release from Denali.
There are currently no approved treatments for slowing FTD-GRN progression, the spokesperson added.
Denali recently became a commercial biopharma, with the Bay Area biotech’s enzyme replacement therapy tividenofusp alfa approved as Avlayah for Hunter syndrome last month. Avlayah is the first approved therapy that can address the cognitive decline associated with Hunter syndrome, a rare disease where malfunctioning cellular metabolism leads to a toxic build-up of large sugars.
Takeda, meanwhile, is in the process of a broad reorganization that the pharma hopes will save around $1.26 billion by 2028. The move follows an overhaul revealed in May 2024, which was meant to push Takeda’s operating profit margin above 30%.
As part of the new plan, Takeda has announced that 634 employees assigned to the company’s U.S. headquarters in Cambridge, Massachusetts, are being laid off. That includes 247 positions based in Massachusetts and 387 in other states.
