FDA Calendar

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.

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Company Name
Adamas Pharmaceuticals Inc
FDA decision on GOCOVRI as a treatment for OFF episodes in Parkinson’s disease patients receiving levodopa-based therapy
Mallinckrodt plc
StrataGraft (BLA)
FDA decision on StrataGraft for the treatment of adult patients with deep partial-thickness thermal burns.
G1 Therapeutics, Inc.
Trilaciclib (NDA)
FDA decision on trilaciclib for small cell lung cancer patients being treated with chemotherapy
TG Therapeutics Inc.
Umbralisib (NDA)
FDA decision on Umbralisib as a treatment for patients with previously treated marginal zone lymphoma
Bristol-Myers Squibb Co.
FDA decision on OPDIVO in combination with CABOMETYX for patients with advanced renal cell carcinom
Exelixis, Inc.
FDA decision on OPDIVO in combination with CABOMETYX for patients with advanced renal cell carcinom
Sarepta Therapeutics
Casimersen (NDA)
FDA decision on Casimersen for DMD amenable to Exon 45 skipping
CorMedix Inc.
Defencath (NDA)
FDA decision on Defencath for the prevention of catheter related blood stream infections
Athenex, Inc.
Oral Paclitaxel in combination with Encequidar (NDA)
FDA decision on Oral Paclitaxel in combination with Encequidar for the treatment of Metastatic Breast Cancer
Regeneron Pharmaceuticals
Libtayo (sBLA)
FDA decision on Libtayo for patients with first-line locally advanced or metastatic non-small cell lung cancer with equal to or greater than 50% PD-L1 expression

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.

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