Regulus Therapeutics Inc. CEO Jay Hagan told investors in a January call the company had no interest in “simply out-licensing” rights to lead candidate farabursen, an oligonucleotide targeting autosomal dominant polycystic kidney disease set to start phase III testing on a path to a potential accelerated approval. And now, there’s no need to, as Regulus found a buyer for the whole company in a deal with Novartis AG valued at about $1.7 billion.
In an indication that has proved difficult for biopharma to conquer, Regulus Therapeutics Inc. disclosed further positive data from its ongoing phase Ib study testing RGLS-8429 in autosomal dominant polycystic kidney disease and laid out its plans to move straight into a phase III trial later this year, with the potential for an accelerated U.S. approval.
In a new study, researchers from Harvard Medical School and Regulus Therapeutics Inc. further investigated the role of miR-155 in Alzheimer's disease (AD).
With a second batch of phase Ib data from the trial testing RGLS-8429 in hand from Regulus Therapeutics Inc., Wall Street is looking forward to results from the third cohort in midyear and weighing prospects with the compound in autosomal dominant polycystic kidney disease. Screening of the fourth cohort will start during the second quarter. Meanwhile, the company has begun to mull a pivotal phase II trial that would launch in the middle of next year, and may help with accelerated approval by the U.S. FDA.
Regulus Therapeutics Inc. has provided an update on its preclinical studies evaluating a library of oligonucleotides designed to inhibit miR-155 for the treatment of amyotrophic lateral sclerosis (ALS).
DUBLIN – After a COVID-19-induced delay that set it back most of last year, Interna Technologies BV has moved its first microRNA-based drug development program into the clinic and has also unveiled €18.5 million (US$22.4 million) in a series B funding round, which it completed in two stages.
