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What is is a tool for traders and investors to track various events within the biotechnology sector. In such a volatile space, it’s critical to understand each company’s drug pipeline and upcoming data releases, especially if you have a stake in them, but also if you’re looking to take a position in them in the near future. Review

These events have the potential to more than double your investment within a trading session if trial results are favorable, however, the opposite can also be true to the downside – your investment can be cut in half if results are unfavorable.

What Are the 6 Stages of Drug Development to Be Aware Of?

There are 6 stages of drug development as defined by BioPharmCatalyst, starting from preliminary testing all the way to FDA approval. This is not an official scale, but does cover most of the critical events within the drug application, testing, and approval process.

  1. Phase 1 Testing the drug in a small number of humans to determine preliminary safety and tolerable dosage
  2. Phase 2Additional testing in a limited patient population to determine effectiveness and possible adverse effects
  3. Phase 3Final testing stage in an expanded population to determine the benefit/risk relationship for administering the drug
  4. New Drug Application (NDA)Drug sponsor is required to file an application to the FDA in order to market drug in the US
  5. PDUFA/FDA ApprovalThe date the FDA makes a decision on an NDA. It either approves the drug or issues a CRL
  6. Complete Response Letter (CRL)Points out specific deficiencies and actions necessary to strengthen approval potential

[Link to’s Full Glossary]’s Core Feature → The FDA Calendar:

The FDA Calendar provides estimated (and sometimes exact) dates and relevant information on upcoming clinical events. This includes all of the stages listed above: Phase 1, Phase 2, Phase 3, NDA, PDUFA, CRL, Advisory Committee, etc. The BioPharmCatalyst team filters through SEC filings and press releases in order to put this list together. Overall, it allows traders to quickly research approaching catalysts and position themselves in trades based on the data provided.

BioPharmCatalyst FDA Calendar

To keep up with the happenings within the biotech industry, BiopharmaCatalyst also offers a couple newsletter options – one offers daily biotech updates and the other offers a weekly review & watch list – Subscribe Here.

There are some limitations to BioPharmCatlayst – like how it doesn’t provide information on every single biotech stock available in the market. And depending on your personal trading style, the information it provides can potentially be slow as well. For example, if your style involves day trading rumors or breaking news, BioPharmCatalyst won’t necessarily provide timely information.

For these reasons, I highly recommend checking out detailed reviews on two of the most robust trading tools for active traders:

#1 Live Newsfeed For Retail TradersBENZINGA PRO REVIEW
#1 Artificial Intelligence Stock Scanning SoftwareTRADE IDEAS REVIEW

How to Profit on Biotech Catalyst Run-Ups:

When it comes to trading stocks on a short-term basis, catalysts can be extremely important. They have the power to change sentiment, bring in volume, and present opportunities before the event itself even occurs.

These events/catalysts can also be paired with technical and/or fundamental analysis:

  • What are the current support & resistance levels?
  • Is there a clear price trend?
  • Does the company have history of secondary offerings?
  • What’s their cash position?
  • What’s management’s track record?
  • How are executives compensated?

If everything checks out, this type of research can increase confidence that there’s more upside potential than downside risk.

Conclusion – is a Valuable Tool For Biotech Traders and Investors:

Without a doubt, understanding what catalysts are approaching in specific biotech stocks and the impact they can have on the value of a security in a matter of just one or a few trading sessions is of extreme importance. This type of volatility can’t be found in most other sectors. While that volatility can open up your portfolio to additional risk, the profit-potential is extraordinary if approached correctly.

Although the platform doesn’t cover every single biotech stock out there (many large-cap and OTC stocks aren’t covered), BioPharmCatalyst is still a valuable tool for traders and investors. Best of all, it’s free.

There are more comprehensive platforms available out there, like for example, but these programs require a monthly subscription. Overall, the suite of tools BioPharmCatalyst provides for researching biotech companies, including the FDA Calendar, IPO Calendar, Drug Pipeline Database, and more, makes for one of the best biotech portals out there for the cost ($0).

The Biotech Sector is Exciting. The Biotech Sector is Volatile. Perform Your Due Diligence & Research at

Written by Matt Thomas (@MattThomasTP)

Related Pages:

Matt Thomas

Founder of, Creator of the Trading Success Framework Course & Trading Paradigm Skool Community, and Intraday Futures Trader Using Auction Market Theory & Profiling (Volume & Market Profile).


  • Strahinja says:

    Trading was recommended to me by my friends, and I never knew that you could make money by investing or trading with biotech. Everyone interested in this kind of undertaking must be properly informed about the FDA approval process, laws and procedures that allow for the creation, testing, and distribution of drugs.

    Thank you.

  • Koda says:

    Biopharm stocks is an area I’m looking to explore in the coming months. I’m spending countless hours doing the research because something like this has to be understood thoroughly if not completely. As other commenters on here have pointed out, BioPharmCatalyst seems to be a brilliant tool that can simplify things for investors. As I build my portfolio, I’ll have this one shot to the top of my priorities. It’s definitely something I’ll be looking into more extensively. Thanks for all the insight. Ciao

  • Cathy Cavarzan says:

    I have followed Kyle Dennis before so that is what caught my eye. BioPharmCatalyst’s core feauture the fda calendar looks like a very useful tool indeed. I had to get out of the stock market for a bit. But I will go back sometime this year myself. Biotechs like in the past have been a good investment and now with the BioPharmCatalyst fda calendar I can see the investment research process getting even better for myself and others.

  • Lok Which says:

    This is really informative and educational for potential traders. I had no idea about BioPharmCatalyst or Biotech Breakouts. Not until I read this, and I really enjoyed it. From this moment I will be following you and I will be looking forward to your next posts to educate me on things I need to know but have no idea about. Thanks for sharing this.

  • JD says:

    Great summary and strong insights around biopharmcatalyst as well as how the FDA process works.

    It definitely makes me want to read your other articles. I think I’ll bookmark it and come back to take a closer look.

    Also, I’m curious if you have either written or come across any other catalyst sites for other sectors (eg. macro, tech, or just ‘important’ events beyond just earnings announcements, etc) ?

    All the best

    • Matt Thomas says:

      Hi JD – that’s an outstanding question. Unfortunately, I haven’t really come across catalyst sites like this for other sectors and I don’t know if they even exist. If they do exist, I’d definitely like to know about them as well. The thing about the biotech/healthcare sector is that there’s such a structured approach to getting drugs approved that it’s somewhat manageable to create a database like But other sectors don’t necessarily have such specific and required catalysts. It takes a lot more unique research and digging to uncover potential catalysts on a company-by-company basis within other sectors. If I come across any, I’ll be sure to share. Take care!

  • Bibian says:

    Investing and establishing it in a bigger way has always been difficult for people out there. but honestly I’m friendly with this particular product. It provided all I need for me to work with it. It’s really good to know about this opportunity for biotech traders, and how the industry works. This information needs to be applauded. Thanks for this!

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