BLACKROCK VIRGINIA MUNICIPAL BOND TRUST
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See all $BHV insider activity →FDA halts SK Biopharm's (326030.KS) epilepsy drug OPCALIM, requesting more data. Novartis' (NVS) $12B drug fails Phase 3. AstraZeneca (AZN) and Amgen (AMGN) report positive lung cancer trial results.
Biohaven's stock fell 13% after the FDA paused enrollment in pivotal trials for its epilepsy drug BHV-7000 due to rodent testing concerns. This is the second regulatory setback in a year. The company expects topline data from one trial later this year but may delay another. Biohaven believes the findings may not be relevant to human safety.
Biohaven announced the FDA placed a partial clinical hold on its experimental epilepsy drug, BHV-7000, according to a company disclosure.
Potential revenue delay from the SK Biopharm deal; market may price in uncertainty.
The hold delays trial readouts and adds regulatory risk, likely pressuring the stock lower in the short term.
The partial hold likely delays development and may depress the stock price.
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FDA halts SK Biopharm's (326030.KS) epilepsy drug OPCALIM, requesting more data. Novartis' (NVS) $12B drug fails Phase 3. AstraZeneca (AZN) and Amgen (AMGN) report positive lung cancer trial results.
3 min readBiohaven's stock fell 13% after the FDA paused enrollment in pivotal trials for its epilepsy drug BHV-7000 due to rodent testing concerns. This is the second regulatory setback in a year. The company expects topline data from one trial later this year but may delay another. Biohaven believes the findings may not be relevant to human safety.
2 min readBiohaven announced the FDA placed a partial clinical hold on its experimental epilepsy drug, BHV-7000, according to a company disclosure.
1 min read
