FDA decisions that move biotech — the second they're posted.
FDA drug approvals and submission decisions, EMA regulatory actions, and clinical-trial readouts — scored for catalyst impact and pushed to your phone within minutes of posting.
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What you get
New drug approvals
NDA and BLA actions from Drugs@FDA — brand name, sponsor, and submission status the moment the action posts.
Regulatory decisions
Approvals, complete response letters, and submission status changes as FDA and companies disclose them — often the most actionable biotech catalyst.
EMA actions
European Medicines Agency authorizations and regulatory decisions — material for any company with an EU pipeline.
Clinical-trial readouts
ClinicalTrials.gov status changes and results postings — the trial events that move small- and mid-cap biotech.
FDA press announcements
FDA press releases as they publish — safety communications and agency actions surfaced in real time.
Catalyst scoring
Each event gets a 0–100 importance score, resolved to a US-listed ticker. Filter by score or source.
Recent catalysts
Real signals from the live feed, with the move in the 24 hours after each event was flagged. Past moves are history, not predictions — and not investment advice.
AXSM +24.5%
FDA regulatory decision
FDA · 30 Apr 2026 · 24h move
VTRS +15.5%
EMA regulatory decision
EMA · 28 Apr 2026 · 24h move
LNTH +12.4%
EMA regulatory decision
EMA · 28 Apr 2026 · 24h move
ANTX +10.7%
Clinical-trial readout
ClinicalTrials.gov · 10 Jun 2026 · 24h move
BYSI −34.8%
Clinical-trial readout
ClinicalTrials.gov · 19 May 2026 · 24h move
HAWK −10.1%
Clinical-trial readout
ClinicalTrials.gov · 9 Jun 2026 · 24h move
Every alert links to the original FDA / EMA / ClinicalTrials.gov source. We show winners and losers — the value is catching the catalyst in real time, not calling direction.
Pricing
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FAQ
openFDA, EMA, and ClinicalTrials.gov are polled continuously at the rate ceiling — typically within minutes of posting.
FDA approvals (Drugs@FDA / openFDA), FDA press releases, EMA regulatory decisions, and ClinicalTrials.gov readouts — all framed as stock catalysts. Dossier (dossier.catalystwire.org) is the separate product for browsing the same data by disease.
No. Catalyst Wire is a regulatory-monitoring tool. Always do your own research; consult a licensed advisor before trading biotech.
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