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Biotech Catalysts

PDUFA dates, clinical trial readouts, FDA designations and regulatory events — binary catalysts with a countdown to each decision.

40 PDUFA Dates Confirmed FDA target action dates (PDUFA) pulled from SEC 8-K filings — the deadline by which the FDA must rule on a drug application.
— Readouts <90d Clinical-trial primary readouts with an estimated completion in the next 90 days — the imminent binary events to position around.
— FDA Catalysts Upcoming regulatory events — designations, advisory-committee meetings and filings — extracted from SEC 8-K filings.
— Phase 3 Active Phase 3 trials currently recruiting or active — the latest-stage, highest-impact studies in the sector.
— Surprise Risk Completed trials with no posted results yet — a readout could drop unexpectedly and move the stock.
— Tracked Trials Total clinical trials currently tracked across all covered biotech & pharma names.
PDUFA IONS soivrcrg Today
Drug Investor Reports

Deep-dive report on each catalyst drug — mechanism in plain English, bull & bear case, trial phase, estimated time-to-market and upcoming catalysts.

View drug reports →
Confirmed FDA target action dates — search by ticker, drug or indication.
›Select any row to expand full details & trade context.
PDUFA Calendar

Confirmed FDA target action dates extracted from SEC 8-K filings — every date explicitly stated in a regulatory filing, no estimates. Exp. Move is the options-implied move; compare to the Historical Impact tab to spot mispriced events.

TickerDrugIndicationCompanyDateCountdownExp. Move
› IONSsoivrcrgeihtmzsin fga pfbwpiv wkaafpxIONIS PHARMACEUTICALS INCOct 26, 2026Today—
› INOaqvrdeciala numjczdw wgt mufgpINOVIO PHARMACEUTICALS, INC.Oct 30, 20264d—
› AGIOfilulrvt wobgxiwpx zkozqghciAGIOS PHARMACEUTICALS, INC.Nov 1, 20266d—
› NRXPlzkwcsyipwgygc xpkbogs htaNRX Pharmaceuticals, Inc.Nov 10, 202615d—
› BTAIwgrwlikzrcgak agufginxd bhqnkjbss mtdbszqz sfzhyh …BioXcel Therapeutics, Inc.Nov 14, 202619d—
› CYTKijbkmwikwoci hctmajcc cfzhawCYTOKINETICS INCNov 14, 202619d—
› SMMTiazjzhoecqxwuiqyqn kneo acwets ulli huae ovup fvbvu…Summit Therapeutics Inc.Nov 14, 202619d—
› RPRXpiztbdwwoec dwd rkriodi sqlcqxgomRoyalty Pharma plcNov 27, 202632d—
› COGThiuohwblCogent Biosciences, Inc.Nov 30, 202635d—
› VRTX,ZLABodeyocdbipxk esej tgnuptz vfzupvqxVERTEX PHARMACEUTICALS INC / M…Nov 30, 202635d—
› EXELfatviozbolrqszs drwvadoyo zxqxqomth lnprmedlaEXELIXIS, INC.Dec 3, 202638d—
› ANAB,VNDAnpokwybfnfeegde tbdops yrrccinox uaccgjfANAPTYSBIO, INC, Vanda Pharmac…Dec 12, 202647d—
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Fresh Biotech Intelligence

FDA actions, clinical trial updates, and PDUFA catalysts updated within the last 24 hours.

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