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FDA Accepts Biohaven's Vyglxia NDA Resubmission, Setting Q1 2027 Decision Date for Rare Ataxia Drug

By Market Flux··1 min read
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Biohaven Ltd. $BHVN

$14.72+25.17%as of publication

5D Change
+28.62%
Notional
$433.13M

Biohaven Ltd. shares surged after the FDA accepted the company's resubmitted new drug application for Vyglxia (troriluzole), a treatment for spinocerebellar ataxia, with a PDUFA target decision date in the first quarter of 2027. The resubmission came after the FDA issued a Complete Response Letter in November 2025, and the updated filing includes supportive analyses. An advisory committee review is expected before a final decision is reached.

The market reaction was sharp. Biohaven opened roughly 48.9% higher in pre-market trading and closed the session up approximately 30.1%, on volume of 10.293 million shares against an average daily volume of 2.585 million.

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  1. BriefingcomGapping up: $BHVN +48.9% $IIIN +10.3% $QS +8.3% $RTO +6.7% $ALLE +5.1% Gapping down: $SNA -10.5% $SON -10% $HXL -9.2% $TTMI -7.2% $IBM -5% $TSLA -4.1%
  2. BPharmCatalyst$BHVN announced FDA acceptance of the NDA resubmission for Vyglxia (troriluzole) for spinocerebellar ataxia following a November 2025 Complete Response Letter. The filing includes supportive analyses, with a Q1 2027 PDUFA date and an advisory committee review expected prior to a decision. $GUTS $SXTC $BHVN $NBTX $ABUS $AAPG $NCEL $AKAN $NIVF $RCUS See More Pre-market Movers at BioPharmCatalyst in the Articles Menu
  3. OpenOutcrier$BHVN (+33.4% pre) Biohaven stock surges on FDA acceptance of drug filing
  4. BenzingaBiohaven Rebounds With FDA Review Date for Rare Disease Drug
  5. TheflynewsMidday Fly By: Meta, Tesla slipping after quarterly reports $META $TSLA $IBM $TXN $LMT $XYZ $NFLX $TSLA $SPCX $BROS $IONS $SHEL $XOM $TSM $SSNLF $SKHY $MAT $BHVN $SPOT $KSS $TTMI $HXL $HON $COR $BMI $FSV $POOL
  6. _Morkie🚨 MARKET TOP MOVERS: $BHVN jumped 30.1% and $XLAB rose 28.7%, while heavy industrials $TTMI (-21.0%), $KALU (-18.8%), and CRS (-18.0%) suffered massive single session drops.