# BiopharmaWatch

> BiopharmaWatch is a biotech investing intelligence platform providing real-time FDA & PDUFA calendars, clinical-trial data, probability-of-approval scores, insider trading, hedge-fund holdings, M&A target scores, and market-moving catalysts for 2,000+ biotech and pharmaceutical stocks. Data is aggregated from primary regulatory sources and updated daily.

BiopharmaWatch helps biotech investors track drug-approval dates, regulatory events, clinical readouts, and company fundamentals. A free tier covers core data; full datasets and proprietary scores are available to subscribers.

## Data sources & methodology

Aggregated and structured from primary sources, updated daily:
- PDUFA dates and FDA decisions - company press releases and SEC filings (8-K); the FDA does not publish pending PDUFA dates
- Clinical trials - ClinicalTrials.gov (NCT records)
- Insider transactions & institutional holdings - SEC EDGAR (Form 4, 13F)
- Financials & prices - company 10-K/10-Q filings and market data

Proprietary models: **Probability of Approval (PoA)** - Bayesian, base-rate-adjusted estimate per drug/indication; **M&A Target Scores** - acquisition-likelihood across the biotech universe; **risk-adjusted NPV (rNPV)** per pipeline asset.

## Core tools

- [FDA Calendar](https://www.biopharmawatch.com/fda-calendar): Upcoming FDA approval/PDUFA dates, advisory committee meetings, and decisions, with probability-of-approval scores.
- [PDUFA Calendar](https://www.biopharmawatch.com/PDUFA-calendar): Every pending FDA PDUFA decision date (Prescription Drug User Fee Act deadline) for this month and next month: date, company, ticker, drug, indication and FDA designations. Free and updated daily. This month and next month also show the BiopharmaWatch probability of approval with its written analysis; later months show it to members.
- [Company Screener](https://www.biopharmawatch.com/company-screener): Screen 2,000+ biotechs by clinical stage, market cap, therapeutic area, cash runway, and upcoming catalysts.
- [CatalystSync](https://www.biopharmawatch.com/catalyst-sync): Custom watchlists with real-time PDUFA / FDA / clinical-readout alerts.
- [Insider Trading Tracker](https://www.biopharmawatch.com/inside-trades): Real-time SEC Form 4 insider buys and sells.
- [Hedge Fund Holdings](https://www.biopharmawatch.com/biotech-hedge-funds): Quarterly 13F institutional positions in biotech.
- [Biotech Earnings Calendar](https://www.biopharmawatch.com/biotech-earnings-calendar): Earnings dates with EPS estimates.
- [Market Movers](https://www.biopharmawatch.com/market-movers): Daily gainers, losers, and unusual volume.
- [IPO & SEC Filings](https://www.biopharmawatch.com/ipo-sec): Upcoming biotech IPOs, S-1 filings, and lock-up expirations.
- [Conference Calendar](https://www.biopharmawatch.com/conference-calendar): Biotech conferences and medical meetings.
- [Biotech News](https://www.biopharmawatch.com/news): Catalyst-tagged biotech news feed.

## Proprietary intelligence

- [M&A Tracker](https://www.biopharmawatch.com/ma-tracker): Acquisition-target scores, deal analysis, and likely acquirers across biotech.
- [Modality Leaderboard](https://www.biopharmawatch.com/modality-leaderboard): Top biotechs ranked by drug modality (mAb, small molecule, gene therapy, ADC, RNAi, CAR-T).
- [Disease Map](https://www.biopharmawatch.com/disease-map): Every indication US-listed biotechs between $100M and $20B are running clinical programmes in, with how many companies compete in each and what the market pays for the median one. 299 indications, 275 developers, $672B of market value.
- [Indication pages](https://www.biopharmawatch.com/disease-map/obesity): One page per indication listing every listed competitor, its lead asset, phase, market cap and next dated catalyst. Example slugs: /disease-map/obesity, /disease-map/mash-nash, /disease-map/achondroplasia, /disease-map/non-small-cell-lung-cancer.
- [Trial Monitor](https://www.biopharmawatch.com/trial-monitor): Real-time clinical-trial status changes.
- [Model Portfolios](https://www.biopharmawatch.com/model-portfolio): Quant biotech strategies and holdings.
- Company pages - per-ticker at `/company/{TICKER}`, e.g. [/company/MRNA](https://www.biopharmawatch.com/company/MRNA), [/company/VRTX](https://www.biopharmawatch.com/company/VRTX): pipeline, upcoming catalysts, PoA scores, financials, and ownership. Company pages with tracked events also carry a free, dated catalyst timeline: up to 50 of the most recent past clinical, regulatory and corporate events (readouts, FDA decisions, filings, designations, deals), each with its date (at the precision the company gave) and a link to its source.
- [API](https://www.biopharmawatch.com/api-docs): Programmatic access to the catalyst, FDA, clinical-trial, and market datasets.

## Historical data

- [Historical FDA Calendar](https://www.biopharmawatch.com/historical-fda-calendar): Past FDA approval decisions and drug success rates.
- [Historical PDUFA](https://www.biopharmawatch.com/historical-pdufa-calendar): Search past PDUFA outcomes by ticker.

## Getting Started: free biotech investing course

- [Getting Started: free biotech investing course](https://www.biopharmawatch.com/learn): An 8-step beginner path with real past examples and our own point-in-time data.
- [How to Invest in Biotech Stocks: A Beginner's Guide](https://www.biopharmawatch.com/biotech-investing/how-to-invest-in-biotech-stocks): How to invest in biotech stocks as a beginner: why they move on FDA and trial news, the 5 checks to run before you buy, and real numbers on the risk.
- [Clinical Trial Phases Explained: Phase 1, 2 and 3 for Investors](https://www.biopharmawatch.com/biotech-investing/clinical-trial-phases-explained): Clinical trial phases explained in plain words: what Phase 1, 2 and 3 test, how many drugs make it through, and why Phase 3 results move biotech stocks most.
- [What Is a PDUFA Date? Meaning, Timeline and What Happens to the Stock](https://www.biopharmawatch.com/biotech-investing/what-is-a-pdufa-date): What is a PDUFA date? The meaning in plain words, how the FDA sets it, and what our data on 1,191 approvals shows about stocks before and after the decision.
- [What Is a CRL (Complete Response Letter) and What It Means for a Biotech Stock](https://www.biopharmawatch.com/biotech-investing/what-is-a-crl-complete-response-letter): What is a CRL (Complete Response Letter)? What the FDA's letter means, why biotech stocks fall on it, what happens next, and a real Corcept example.
- [Biotech Cash Runway and Dilution: How Long the Money Lasts](https://www.biopharmawatch.com/biotech-investing/biotech-cash-runway-and-dilution): How to read a biotech's cash runway and dilution risk: the simple math, why short runways mean new shares, and real data on stocks trading below cash.
- [Biotech Hedge Funds and Insider Buying: Following the Smart Money](https://www.biopharmawatch.com/biotech-investing/biotech-hedge-funds-and-insider-buying): How to track biotech hedge fund holdings (13F) and insider buying (Form 4), which signals have mattered in the past, and where each one can mislead you.
- [Short Interest and Days to Cover: How to Read a Crowded Short](https://www.biopharmawatch.com/biotech-investing/short-interest-and-days-to-cover): What short interest and days to cover mean for biotech stocks, how to read a crowded short, and real data on when high days to cover helped and when it didn't.
- [The Biotech Stock Checklist: 14 Boxes, Tested on 22,234 Past Setups](https://www.biopharmawatch.com/biotech-investing/biotech-stock-checklist): A 14-box biotech stock checklist covering cash, owners, catalysts, science and price, tested on 22,234 past stock-months, with 8 winners and 2 misses.
- [Orphan Drug Designation: What It Means for a Biotech Stock](https://www.biopharmawatch.com/biotech-investing/orphan-drug-designation): What orphan drug designation is, the 7 years of market exclusivity and other perks it brings, and what our data shows about biotech stocks that have one.
- [BLA vs NDA: The Difference Between the Two FDA Applications](https://www.biopharmawatch.com/biotech-investing/bla-vs-nda): BLA vs NDA explained: which drugs need a Biologics License Application or a New Drug Application, how each is reviewed, and why biologics get 12 years.
- [Breakthrough Therapy vs Fast Track: FDA's Faster Paths Explained](https://www.biopharmawatch.com/biotech-investing/breakthrough-therapy-vs-fast-track): Breakthrough therapy vs fast track designation, priority review, accelerated approval and review vouchers explained, plus what our data shows for biotech stocks.
- [FDA Advisory Committee (AdCom) Meetings: How the Vote Moves a Stock](https://www.biopharmawatch.com/biotech-investing/fda-advisory-committee): What an FDA advisory committee (AdCom) meeting is, how often the FDA follows the vote, and a real example where the FDA approved a drug after a no vote.
- [What Are Topline Results? How to Read a Trial's First Data](https://www.biopharmawatch.com/biotech-investing/what-are-topline-results): What topline results mean in a clinical trial, why biotech stocks jump or crash on them, and why the full data later can move the stock again.
- [Randomized, Double-Blind, Placebo-Controlled Trials, Explained](https://www.biopharmawatch.com/biotech-investing/randomized-double-blind-placebo-controlled-trial): What randomized, double-blind and placebo-controlled mean in a clinical trial, why this design is the gold standard, and what our data shows for biotech stocks.
- [Trial Success Score (PTRS): The Odds a Drug Makes It](https://www.biopharmawatch.com/biotech-investing/trial-success-score-ptrs): What a trial success score (PTRS) is, how phase, disease area and trial design shape a drug's odds of approval, and what the score can and can't tell you.
- [Primary vs Secondary Endpoints: What a Trial Really Has to Prove](https://www.biopharmawatch.com/biotech-investing/primary-vs-secondary-endpoints): Primary vs secondary endpoints explained: what each one measures, why missing the primary endpoint usually sinks a biotech stock, and two real examples.
- [XBI vs IBB: Which Biotech ETF Is Which?](https://www.biopharmawatch.com/biotech-investing/xbi-vs-ibb): XBI vs IBB compared: how each biotech ETF weights its stocks, how they performed from 2022 to 2026, and which one swings harder when biotech moves.
- [Biotech M&A: What Big Pharma Buyers Look For](https://www.biopharmawatch.com/biotech-investing/biotech-mergers-and-acquisitions): Biotech M&A explained: why big pharma buys biotech companies, what makes a takeover target, how big the premiums have been, and why chasing rumors is risky.
- [Biotech Investing 101 full guide](https://www.biopharmawatch.com/investing-masterclass): The same ground in 17 short lessons on one page.

## Questions BiopharmaWatch answers

- When is the FDA decision (PDUFA date) for a given drug or company?
- Which PDUFA dates are coming up this month and next month?
- What is the probability of approval for a specific drug or indication?
- Which biotech companies are likely acquisition targets?
- What insider buying or hedge-fund (13F) activity is happening in a stock?
- What upcoming catalysts (data readouts, FDA decisions) does a company have?
- What catalysts has a company already had, and when (dated readouts, FDA decisions, filings, with sources)?

## Company

- [About](https://www.biopharmawatch.com/about): About BiopharmaWatch
- [Blog](https://www.biopharmawatch.com/blog): Biotech investing articles and analysis
- [Contact](https://www.biopharmawatch.com/contact-us): Get in touch

## Optional

- [Editorial Policy](https://www.biopharmawatch.com/editorial-policy): Editorial standards and data sourcing
- [Disclaimer](https://www.biopharmawatch.com/disclaimer): Investment disclaimer
- [Privacy Policy](https://www.biopharmawatch.com/privacy-policy): Privacy policy
- [Terms of Service](https://www.biopharmawatch.com/Terms-service): Terms of service