Biohaven (BHVN) stock plummeted Thursday after the company paused enrollment in a midstage study of its seizure treatment due to safety concerns.
The Food and Drug Administration is now requiring Biohaven to ***** s the potential for human toxicity from a metabolite in the drug, opakalim. Opakalim is in testing as a treatment for focal onset seizures. But, in rats, it proved toxic.
Dosing is still ongoing. But the rodent toxicity setback likely delays potential regulatory approval. That's a boon for Xenon Pharmaceuticals (XENE), which is in late-stage testing with its drug, azetukalner. Both drugs work by opening potassium channels in the nervous system to calm overactive brain cells.
On the stock market today, Biohaven stock dropped 14.7% to 12.79. Shares fell below their 21-day and 50-day moving averages on the news, MarketSurge shows. Xenon stock slid a fraction to 58.80.
To ask for FDA approval, Biohaven will need the results of studies called RISE-2 and RISE-3. The hold was placed on the former, but the latter is still ongoing. The company expects to have the results from RISE-3 later this year.
#toxicity
The Food and Drug Administration is now requiring Biohaven to ***** s the potential for human toxicity from a metabolite in the drug, opakalim. Opakalim is in testing as a treatment for focal onset seizures. But, in rats, it proved toxic.
Dosing is still ongoing. But the rodent toxicity setback likely delays potential regulatory approval. That's a boon for Xenon Pharmaceuticals (XENE), which is in late-stage testing with its drug, azetukalner. Both drugs work by opening potassium channels in the nervous system to calm overactive brain cells.
On the stock market today, Biohaven stock dropped 14.7% to 12.79. Shares fell below their 21-day and 50-day moving averages on the news, MarketSurge shows. Xenon stock slid a fraction to 58.80.
To ask for FDA approval, Biohaven will need the results of studies called RISE-2 and RISE-3. The hold was placed on the former, but the latter is still ongoing. The company expects to have the results from RISE-3 later this year.
#toxicity
2 months ago
