Live record: 8/9 pre-decision calls correct · most recent wins TVTX +33% and LGND +14% · 102-event backtest + 73-event $1M IRR on real Polygon data · View everything logged →
Biotech PDUFA scanner · 300+ tickers + every filer

Catch the +33% approval.
Flag the -64% CRL.

I was spending five hours per ticker reading FDA history, S-3 shelf registrations, and clinical trial data, and still missing the one thing that tanked the trade. So I built a scanner that reads all of it for me, every day. 300+ biotechs worth tracking, plus every company with an upcoming PDUFA. Eight risk layers. Every pre-decision call logged publicly. Wins and losses.

See the track record →

Cancel any time · No contracts · Solo-built by a Navy vet · Billed monthly via Stripe

SCANNER v14 — LIVE OUTPUT
══════════════════════════════════════════════════
✅ TVTX APPROVED · called 74.2% PoA · move +33.29%
✅ LGND APPROVED · called 71.5% PoA · move +14%
✅ VNDA APPROVED · called 78% PoA · move +45%
✅ SNY Sarclisa APPROVED · called 74% PoA · STN VERY LOW ✓ · move +2%
──────────────────────────────────────────────────
❌ REPL 2nd CRL · called 84% PoA — model miss
STN HIGH correctly flagged -64% downside risk
❌ GRCE CRL on nimodipine · called 72% PoA — manufacturing CRL
STN VERY LOW missed -52% · double loss logged
──────────────────────────────────────────────────
📊 Live: 9/11 Resolved · 2 Misses Logged (REPL, GRCE)
RCKT -20% STN:HIGH ⚠️ · DNLI +8% · BIIB -5%
──────────────────────────────────────────────────
🧪 Backtest: 102 scored · 73 with real IRR data
💰 Portfolio: $1M → live IRR · Polygon.io close data
──────────────────────────────────────────────────
300+ tickers + every PDUFA filer · 8 risk layers · Updated DAILY
══════════════════════════════════════════════════

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Every classification logged before the event resolved. Wins and losses both on the record.

What the model got right and wrong
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TICKER SCANNER CALL RESULT POST-DECISION MOVE
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Scanner outputs are quantitative classifications from public data. Not investment advice. Past accuracy does not guarantee future results.

See Today's Live Classifications — $29.99/mo → Cancel any time · Access in 60 seconds

What you actually get for $29.99.

No demo videos. No mockups. This is the live product. Subscribers see this for every ticker, every day.

01 · Scanner
Every PDUFA scored daily.
56 events tracked at last refresh. Sort by Net Edge. Filter by grade. Search any ticker. ELITE setups flagged at the top.
Submarine Catalyst PDUFA Scanner showing 56 tracked events, ARVN and NUVL with PoA, STN Risk, Dilution and Net Edge scores
02 · Detail page
Every ticker. Eight layers on one screen.
PoA, STN Risk, Dilution, Innovation, Net Edge — plus market cap, price, 30-day change, and realized volatility.
ARVN catalyst detail page showing 81.9% PoA, STN Risk 66, MINIMAL dilution, 82/100 Innovation score, market cap $667.8M, 30-day change -16.3%
03 · AI Research
Specific clinical detail, not generic filler.
Drug class, comparators, mechanism, first-in-class implications. Written for traders who already know what a PROTAC is.
AI executive summary on ARVN vepdegestrant explaining first-in-class PROTAC SERD mechanism, first-time approver caveat, 9x TAM-to-Cap ratio implications
04 · Transparency
Every score, fully documented.
Indication base rate, review pathway, CMC haircut. STN amplifiers itemized. No black boxes — audit any classification.
Approval probability breakdown showing 81.9% Indication PoA, PDUFA review pathway, 0% CMC haircut, with HIGH STN risk amplifiers itemized
Get Inside — $29.99/mo →

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$1M baseline — fixed 7.5% sizing on every call.

Conservative baseline: a fixed 7.5% of equity on every resolved live call, no concentration on the highest-conviction setups. LONG and SHORT follow the classification's trade_type. No leverage, no overlap, no fee model. The point isn't the dollar return at uniform sizing — it's that with only 11 resolved events the sample is still small, and the equity curve is dominated by the two CRL misses (REPL, GRCE) sized identically to the +45% VNDA win. The full track record page shows the same simulation with concentration toggles and the 73-event Polygon backtest.

Starting
$1.00M
initial capital
Ending Equity
calculating…
CAGR (IRR)
annualized
Max Drawdown
peak-to-trough

Biotech catalyst data is either free and useless or $2k/mo and overkill.

A PDUFA calendar without risk scoring tells you when the event is. It doesn't tell you whether the setup is worth trading. That gap is the whole point of this tool.

  DIY research Calendar-only tools Bloomberg Terminal Submarine Catalyst
Monthly cost $0 + 5 hrs/ticker $0 – $200 ~$2,000+/mo $29.99/mo
PDUFA calendar Manual from FDA.gov 300+ + every filer
Probability-of-approval scoring You guess Analyst reports, not scored Hay 2014 · Wong 2019
Sell-the-news risk layer You guess HIGH flagged REPL -64%, RCKT -20%
Dilution radar (SEC EDGAR) Manual 424B5 scans Manual Auto every 6 hrs
Buyout probability model You guess 14-company patent cliff DB
TAM / Market Cap ratio Spreadsheet Per-indication TAM
Live track record (wins + losses) Your trading journal N/A Public, including REPL miss
Pre-run calibration backtest N/A 102-event, Feb 2024 →
AI deep-dive per ticker You write it Partial Any tracked ticker
Runs on your phone ~ tabs and PDFs Bloomberg Anywhere $

Bloomberg pricing from publicly reported figures. Calendar-only tools category includes free PDUFA tracker sites and low-cost calendar apps. Comparison is opinion based on my own use of each category — you're welcome to disagree.

Three data layers. Eight scoring layers.No black boxes

Every data point traces back to a public source. FDA filings, SEC EDGAR, ClinicalTrials.gov v2, Federal Register, openFDA, Finnhub, Polygon.io. You can audit any score on any ticker.

Bucket 01 · Regulatory & Clinical

Catalysts the calendar tools don't show you.

PDUFA dates are table stakes. The real signal is what's around them — AdCom meetings, Phase 2/3 readouts, CRL resubmissions.

  • PDUFA calendar · pulled and scored daily
  • AdCom meetings · via Federal Register API
  • Phase 2/3 readouts · via ClinicalTrials.gov v2
  • CRL recovery filter · isolates CMC-only resubmissions
  • Drug asset database · resolves ticker drift
Source: FDA.gov · Federal Register · ClinicalTrials.gov v2
Bucket 02 · Risk Signal Layers

Eight independent scores. One composite.

Every layer is documented, weighted, and recalibrated after each resolved event. This is where the edge lives.

  • Probability of Approval · Hay 2014 · Wong 2019
  • Sell-the-News Risk · pricing-in + dilution + urgency
  • Dilution Radar · SEC EDGAR scans every 6 hrs
  • Buyout Probability · 8 factors, patent cliff DB
  • TAM / Market Cap ratio · per-indication market size
  • Net Edge Score · composite of all eight
Source: SEC EDGAR · peer-reviewed approval rates · proprietary weights
Bucket 03 · Market Context

The stuff that moves the stock.

Catalysts don't fire in a vacuum. The rest of the market context — earnings windows, medical conferences, safety reports — all gets scored and placed on the same calendar.

  • Earnings calendar · 90-day window via Finnhub
  • Conferences · JPM · ASCO · AACR · ASH · ESMO
  • Safety signals · openFDA FAERS spike detection
  • Live price & volume · Polygon.io
  • Chart-pattern classifier · coiling · building · extended
Source: Finnhub · openFDA · Polygon.io · static conference manifest

Eight signal layers. Every modifier documented.

Each signal is sourced and weighted. The RCKT and VNDA panels below show the same model evaluating two approvals — one that made money, one that lost it. Same PoA range, very different outcomes. That's the point.

🧬
Indication Classifier
Maps drug to 16 therapeutic areas. Applies published FDA phase-3→approval rates. Oncology 85.5% · Rare/Orphan 86.2% · CNS 49%.
Hay 2014 · Wong 2019
📋
Review Pathway
Breakthrough 90% · Priority NME 81% · Accelerated 72% · Resubmission 65%. Blended 50/50 with indication rate.
FDA PDUFA reports
🗳️
AdCom Vote Parser
Extracts numerical votes (e.g. 8-7, 14-0). Unanimous → 1.25× multiplier. Close vote → 0.82×. Also feeds STN Risk.
PMC10329213
📁
SEC EDGAR Dilution Radar
Scans 424B5, S-3 shelf, ATM agreements, and sales-agent changes near PDUFA dates every 6 hours.
SEC EDGAR API
🧪
ClinicalTrials.gov v2
Phase 3 trial status check. Completed → 1.02× boost. Terminated/suspended → 0.70× discount.
CT.gov API v2
📐
Convexity Model
6-factor asymmetry score: proximity, price depression, short squeeze potential, expected move, liquidity, size tier.
Proprietary
📊
TAM / Market Cap
Drug TAM across 50+ indications ($20M–$50B). Compared to market cap. 10x+ ratio = massive upside. <1x = limited room.
Industry data
🎯
Self-Calibrating Weights
After each resolved PDUFA the model recalibrates. 8/9 on live resolved · only miss (REPL 2nd CRL) logged. Plus 102-event backtest + 73-event $1M IRR on real Polygon data.
Live log + backtest
// RCKT — why approval lost money
PoA (approved ✓)
77.5%
STN Risk
HIGH
Dilution ($100M ATM)
HIGH
TAM / Cap
0.04x
Buyout
LOW

Actual move
-20%

The lesson
Approval ≠ profit. The scanner saw it before I did.
⚠️
// VNDA — why approval made money
PoA (approved ✓)
78%
STN Risk
MODERATE
Dilution
MINIMAL
TAM / Cap
5.0x

Actual move
+45%

The edge
MODERATE STN but 5x TAM and no dilution = real upside.
+45%

Every cap tier. Small-caps are where the asymmetry lives.

Submarine Catalyst tracks every FDA binary event across the full market cap spectrum — not just the small-caps retail traders already crowd into.

SC
Small-Cap · $0–$2B

Highest volatility. Highest spike potential. Highest dilution risk. Where the asymmetric PDUFA trades live — and where STN Risk and the Dilution Radar add the most value.

MC
Mid-Cap · $2B–$10B

More institutional coverage, more efficient pricing. Moderate moves on approval (+10 to 25%). sNDA/label expansions are common. STN Risk goes up with coverage.

LC
Large-Cap · $10B+

One drug rarely moves the needle. Tracked for competitive dynamics, pipeline intelligence, and the ripple effects a large-cap approval has on smaller players in the same therapeutic area.

A submarine, a spreadsheet, and a problem nobody was solving.

I spent three years in the Navy, most of it on the USS Montana during dry dock in Newport News, Virginia. Eleven months inside a boat that wasn't in the water yet. What you learn in that environment is that everything runs on procedure, verification, and trusting your instruments when your instincts are screaming something else. That stuck with me.

I got medically separated and enrolled at Texas Tech for a BBA in IT Systems. Somewhere between learning SQL and reading SEC filings for fun, I started trading biotech PDUFA events. The problem was obvious pretty fast. I could spend five hours researching a single ticker — FDA history, EDGAR filings, clinical trial data, cash runway math — and still miss the one thing that tanked the trade. So I started building a tool to do the research for me.

That tool became Submarine Catalyst. It started as a Python script on my laptop. Now it runs eight analysis layers across 300+ biotechs I actually track, plus every company with an upcoming PDUFA — updated daily by an automated pipeline that costs me less than $30 a month to operate. I'm 23, I'm still in school, and I built this because I needed it. Turns out other people need it too.

The RCKT event is what made this real. The model said 77.5% chance of approval. It got approved. The stock dropped 20%. I posted the loss publicly and it got 21,000 views. That one outcome led to the Sell-The-News Risk layer, the Dilution Radar, and every feature that separates this from a basic PDUFA calendar.

The two misses are in the record too. REPL on April 10, 2026 — model called 84%, FDA issued a 2nd CRL, stock dropped 64%. STN HIGH had correctly flagged severe downside before the decision. GRCE on April 23, 2026 — model called 72%, FDA issued a manufacturing CRL on nimodipine, stock dropped 52%. STN missed that one. Both losses logged the day they resolved, not after I cherry-picked which to publish. Every outcome gets logged, including the ones that hurt. That's the whole point.

300+Biotechs Tracked
8/9Live Calls Correct
73IRR Tradable Events
14Big Pharma Patent Cliffs

One tier. Full database. Cancel whenever.

No freemium walls. No data delays. No upsells. Every risk layer on every ticker, updated daily.

    What's included
  • 300+ biotechs worth tracking + every PDUFA filer each year
  • Eight risk layers on every scored event
  • 10-tab research calendar · PDUFA · Earnings · Clinical · AdCom · CMC Recovery · Dilution Watch · Conferences
  • AI research tool · deep dives on any ticker
  • Compare tool · side-by-side on 2-4 companies
  • Full backtest record · PoA calibration curve + $1M IRR
  • Every outcome documented · including losses
Founding-member rate
$ 29.99 /month

Full database · all tickers · all layers

  • 300+ curated biotechs + every PDUFA filer
  • Eight independent risk layers per event
  • Sell-The-News Risk classification
  • Dilution Radar — SEC EDGAR, every 6 hrs
  • Buyout Probability — 8-factor, patent cliff DB
  • TAM / Market Cap ratio
  • CMC Recovery filter
  • AI Research Module — any ticker
  • Compare Module — 2-4 companies side-by-side
  • 10-tab research calendar
  • Full backtest with real outcomes
✓ Cancel any time. No contracts. No cancellation fees. Access runs to the end of your billing period, then stops billing.

Billed monthly via Stripe · Access within 60 seconds

Straight talk This is a quantitative research tool, not investment advice. A high score reflects favorable evidence — it does not guarantee approval. Biotech binary events carry substantial risk of total loss.

It's built for traders who already understand that risk and want a systematic edge evaluating setups. If you're looking for someone to tell you what to buy, this isn't it. If you're looking for eight risk layers scored on every biotech in the universe so your research takes ten minutes instead of five hours — that's what this is.

Common questions.

Straight answers. No filler.

Full access to everything. 300+ biotechs worth tracking plus every company with an upcoming PDUFA — small, mid, large cap. Every PDUFA event scored with approval probability (PoA), Sell-The-News Risk, Dilution Radar (EDGAR scans every 6 hours), Buyout Probability, TAM/Cap ratio, Net Edge Score, and ELITE/STRONG/WATCH/WEAK grading. The AI Research Tool for any ticker. The Compare Tool for 2-4 companies side-by-side. 10-tab catalyst calendar covering PDUFAs, earnings, clinical readouts, AdComs, dilution watch, conferences. Post-catalyst behavioral patterns. The full education section. The transparent track record. Updated daily. No feature gates, no data delays.
No. It's a quantitative scoring tool. Every output is a data classification from public sources — FDA filings, SEC EDGAR, clinical trial status, market data. It does not tell you what to buy or sell. All position sizing, risk management, and final trade decisions are yours. Biotech binary events carry substantial risk of total loss. I am not a registered investment adviser, broker-dealer, or financial planner.
The base rates come from peer-reviewed literature (Hay et al. 2014, Wong et al. 2019) and FDA PDUFA performance reports. Individual scores are modified by seven other signal layers. Live record: 8/9 pre-decision calls correct. A separate 102-event retrospective backtest runs the same PoA engine against every FDA NME decision from Feb 2024 onward — published on the track record page with per-bucket calibration. The scoring functions are byte-for-byte identical to production (synced-block comment prevents drift). Of those scored events, 73 have real Polygon.io post-decision price data and feed the $1M portfolio IRR simulation — placeholder tickers, non-US exchanges, and delisted names are excluded rather than modeled, so every IRR P&L figure traces back to actual market activity. No model is perfect. The REPL miss is in the record.
Daily via automated pipeline. New PDUFA events sync from FDA each morning. EDGAR Dilution Radar scans SEC filings for every active ticker every 6 hours — checking for 424B5 prospectus supplements, S-3 shelf registrations, ATM agreements, and insider transactions. Scoring engine recalculates PoA, STN Risk, Dilution Score, and Net Edge Score after each data refresh. When a PDUFA resolves, the outcome is logged with actual stock-move data and the model's weights recalibrate.
A subscriber-only AI analyst that runs deep dives on any biotech. For PDUFA events: executive summaries, SEC filing context, dilution risk assessment, bull/base/bear price scenarios. For companies without active PDUFAs: pipeline overview, catalyst timeline, buyout potential, competitive landscape. It knows the scanner's data — PoA, STN Risk, Dilution, Buyout Probability, TAM/Cap — and builds analysis on top of it.
You don't have to. Every classification is logged before the event resolves — wins and losses both. The REPL 2nd CRL miss is in the record. The RCKT -20% move on approval is in the record. The VNDA +45% win is in the record. The 102-event retrospective backtest is public with a per-bucket calibration curve. The $1M portfolio IRR runs on real Polygon.io close-to-close data, not theoretical. Compare that to a calendar-only tool that just lists dates. If the track record looks wrong, don't subscribe.
A 0-100 score estimating acquisition likelihood post-catalyst. Factors: first-in-class status, orphan/breakthrough designation, PRV eligibility, existing partnerships, market cap tier, commercial infrastructure, and therapeutic area M&A history — scored against a 14-company Big Pharma patent cliff database (ABBV, MRK, PFE, LLY, BIIB, and 9 others). Small-cap biotechs with first-in-class approved drugs and no sales force are the most common acquisition targets — the score identifies them before the market does.
TAM (Total Addressable Market) is the estimated annual peak revenue of the drug's indication. TAM/Cap ratio compares that market to the company's current market cap. 10x = drug market is 10 times company value (significant upside). Below 1x = drug market is smaller than company (limited upside even on good news). RCKT had 0.04x (gene therapy for ~30 patients). VNDA had 5x (gastroparesis, ~$1.5B market). Ratio predicted which approval was worth trading.
Yes. Billing is monthly via Stripe. Cancel from your dashboard any time — no contracts, no cancellation fees, no questions. Access runs through the end of the current billing period, then stops.
Me. Davis Rackler. 23-year-old Navy veteran, full-time student at Texas Tech (BBA in IT Systems). I served three years on the USS Montana, got medically separated, started trading biotech PDUFA events, got frustrated with how long the research took, and built a tool to automate it. I run it solo. It costs me less than $30/month to operate. Every outcome gets logged publicly whether it makes me look good or not. If you want to know more, the full story is in the "Who built this" section above — or reach out on X (@DRackler).

See today's live classifications.

300+ biotechs worth tracking plus every PDUFA filer. Eight risk layers. Every score sourced and documented. $29.99/month, cancel any time. I built this because I needed it — turns out you probably do too.

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