Biohaven
NEWS
The FDA previously refused to review Biohaven’s candidate in the indication due to a failed late-stage trial. However, the company is now planning to file an NDA in the fourth quarter of 2024.
Despite Biohaven’s bispecific protein degrader cutting autoantibody IgG levels by up to 37% in an early-stage study, investors saw it as “below the high bar” of 60%, according to William Blair analysts.
With a potential $509 billion up for grabs by 2028, companies including Biogen, Sage, Karuna Therapeutics and Cerevel Therapeutics are vying to bring their drugs across the regulatory finish line.
Biohaven will focus on developing therapeutics that modulate the Kv7 Ion Channel for the treatment of neurological and neuropsychiatric diseases. The new entity launched with $257.8 million in cash.
Clene’s gold nanocrystal asset CNM-Au8 failed to hit the primary endpoint in the HEALEY ALS trial, but strong survival signals at six months warrant additional exploration in treating ALS.
Biohaven Pharma’s verdiperstat, an experimental treatment for amyotrophic lateral sclerosis, failed to distinguish itself from placebo in clinical testing, the company announced Thursday.
Intercept Pharmaceuticals, Annovis Bio and Biohaven Pharma are moving forward with late-stage Phase III clinical trials.
A new report by PwC projects that the second half of this year will see a “flurry of deals activity across all areas of the sector.”
It was an extraordinarily busy week for clinical trial news and updates due to several prominent international conferences. Here’s a look at some of the highlights.
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