FDA Calendar

FDA Calendar

The Biopharmcatalyst PDUFA and FDA calendar review dates can play a big role in timing your trades, But not the way you may think.

These can be significant catalyst events for biotech and pharma stocks when the decisions are announced. In addition to the actual FDA decision biotech stocks may experience a run-up in anticipation of the scheduled decision/review dates. Having prior knowledge of the this potential catalyst can go a long way toward maximizing profit or limiting a loss while trading biotech and pharma companies stocks. However, these events are not the only driver in biotech stock prices (see below).

Our editors cover early to late stage biotech and pharma companies often. Learn more about our trading group and see our recent coverage & track record

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The PDUFA/FDA Approval Calendar and Finding Potential FDA Approval Catalyst Dates 

BioPharmCatalyst provides a pharmaceutical data bank that keeps track of Biotech stocks, FDA approvals, Advisory Committee activity, PDUFA and Phase 2 & 3 Trial data. To access this calendar just click the link below.

View FDA Calendar

In Addition to FDA Review Results, The Following Events May Significantly Affect a Biotech or Pharmaceutical Companies Stock Price

The FDA calendar is great for clinical trial results that are pending or just released. However, this is not the be all, end all to success in trading biotech stocks.

Traders News Source Top 10 Catalyst Events for Biotech Stocks 

  1. Presentations or buzz occurring at key scientific and medical meetings; for oncology from which many biotech’s sprout
  2. Peer company dealing with the same or similar biotechnology/pathway clinical trial results
  3. Collaboration with a major (Research Clinic, Large Biopharma, University Etc.) 
  4. FDA holds on a clinical trial either imposed or lifted
  5. Management taking the “poison pill” strategy against possible hostile bids
  6. Earnings are reported (If they have an approved drug commercially available)
  7. Merger & acquisition activity
  8. Licensing announced including upfront/milestone payments
  9. Key management (C-level for biotech) changes
  10. Insider buys/sells or Major shareholder (usually investment firms or hedge fund managers) buys/sells

Biotech investing can be very profitable for those who are well informed and patient. Keep in mind these stocks can make a significant move following any one of the above mentioned catalyst events or when positive data is released during any stage of the FDA approval process.

Biotech companies with a robust pipeline, experienced management teams, and a clear pathway to approval are what we seek to deliver to you in our related reports.

We offer some great resources for biotech stock research and news. In addition to our reports and notifications, keep an eye on our FDA/Biotech resources and feeds linked below.

New Drug Applications

Clinical Trial Results

New Drug Approvals

FDA and Cannabis