PDUFA dates and FDA Panel Review dates are very important catalysts because they are ‘make or break events’ for biotech stocks.
The goal date set by the FDA for announcing its decision on a company’s New Drug Application/ Biologics License Application/sBLA/sNDA after reviewing the applications is known as the PDUFA date.
Usually, the stocks experience a run-up going into the scheduled FDA Approval decision/FDA Panel review events. So, having prior knowledge of the key dates goes a long way toward maximizing profit or minimizing loss while investing in the volatile biotech stocks.
Listed below are large cap, mid cap and small cap stocks with pending regulatory catalysts.
Get in-depth analysis and insight on investing in the high-stakes Biotech and Pharma sectors. Check out RTT Biotech Investor and our Biotech Home Page.
ALSO READ - COVID-19 Drugs In Development Calendar which lists Companies that are in Race to find a Treatment or Vaccine for the Novel Coronavirus.
March 31, 2026 15:49 ET In this week’s video, we’ll cover major biotech moves and breakthroughs - from Novartis and Merck’s blockbuster acquisitions to the first new Hunter syndrome therapy in two decades. We’ll also look at a promising alternative to daily insulin injections and the near-term catalyst for Q3 Bio, which has been hitting new 52-week highs.
Renault Group has teamed up with Thales to create a new military vehicle, marking the automaker's push into the defense arena as European countries ramp up military spending due to rising geopolitical tensions.
Many women may not be choosing the most effective medicine for period cramps, according to a large study that analyzed supermarket purchase data. The study, published in PLOS Digital Health, examined shopping records from supermarkets in England between 2006 and 2015. The data showed that about half...
Completely removing sugar from your diet may not be as healthy as you think. A new study in mice suggests that eliminating sucrose, a common type of sugar, could have unexpected effects on gut health and metabolism. "This research may influence future dietary recommendations by emphasizing the importance...
Neumora Therapeutics Inc. (NMRA), a clinical-stage biopharmaceutical company, on Monday announced the discontinuation of the Phase 3 KOASTAL program evaluating Navacaprant for the treatment of major depressive disorder. Following the announcement, shares fell over 50% on Monday. The KOASTAL-2...