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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
Drug
Event
Outcome
Details
Adamas Pharmaceuticals Inc
(ADMS)
GOCOVRI (sNDA)
02/01/2021
FDA decision on GOCOVRI as a treatment for OFF episodes in Parkinson’s disease patients receiving levodopa-based therapy
-
Mallinckrodt plc
(MNK)
StrataGraft (BLA)
02/02/2021
FDA decision on StrataGraft for the treatment of adult patients with deep partial-thickness thermal burns.
-
G1 Therapeutics, Inc.
(GTHX)
Trilaciclib (NDA)
02/15/2021
FDA decision on trilaciclib for small cell lung cancer patients being treated with chemotherapy
-
TG Therapeutics Inc.
( TGTX, TGTX.OB)
Umbralisib (NDA)
02/15/2021
FDA decision on Umbralisib as a treatment for patients with previously treated marginal zone lymphoma
-
Bristol-Myers Squibb Co.
(BMY)
OPDIVO (sBLA)
02/20/2021
FDA decision on OPDIVO in combination with CABOMETYX for patients with advanced renal cell carcinom
-
Exelixis, Inc.
(EXEL)
CABOMETYX (sNDA)
02/20/2021
FDA decision on OPDIVO in combination with CABOMETYX for patients with advanced renal cell carcinom
-
Sarepta Therapeutics
(SRPT)
Casimersen (NDA)
02/25/2021
FDA decision on Casimersen for DMD amenable to Exon 45 skipping
-
CorMedix Inc.
(CRMD)
Defencath (NDA)
02/28/2021
FDA decision on Defencath for the prevention of catheter related blood stream infections
-
Athenex, Inc.
(ATNX)
Oral Paclitaxel in combination with Encequidar (NDA)
02/28/2021
FDA decision on Oral Paclitaxel in combination with Encequidar for the treatment of Metastatic Breast Cancer
-
Regeneron Pharmaceuticals
(REGN)
Libtayo (sBLA)
02/28/2021
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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