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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.

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.
Company Name
Drug
Event
Outcome
Details
Eli Lilly And Co.
(LLY)
OLUMIANT (sNDA)
Early Q3 2021
FDA decision on OLUMIANT for the treatment of adults with moderate to severe atopic dermatitis
-
Incyte Corporation
(INCY)
OLUMIANT (sNDA)
Early Q3 2021
FDA decision on OLUMIANT for the treatment of adults with moderate to severe atopic dermatitis
-
Pfizer Inc.
(PFE)
Abrocitinib (NDA)
Jul 2021
FDA decision on Abrocitinib for the treatment of moderate to severe atopic dermatitis (AD) in patients 12 and older.
-
Pfizer Inc.
(PFE)
XELJANZ (sNDA)
Early Q3 2021
FDA decision on XELJANZ for the treatment of active ankylosing spondylitis in adults
-
AbbVie
(ABBV)
Atogepant (NDA)
Late Q3 2021
FDA decision on Atogepant for the preventive treatment of migraine
-
AbbVie
(ABBV)
RINVOQ (Upadacitinib) (sNDA)
Early Q3 2021
FDA decision on RINVOQ in the treatment of adults and adolescents with moderate to severe atopic dermatitis
-
AstraZeneca PLC
(AZN.L, AZN)
Anifrolumab (BLA)
2H 2021
FDA decision on Anifrolumab for the treatment of systemic lupus erythematosus
-
Provention Bio, Inc.
(PRVB)
Teplizumab (BLA)
07/02/2021
FDA decision on Teplizumab for the delay or prevention of clinical type 1 diabetes (T1D) in at-risk individuals
FDA issues Complete Response Letter for teplizumab for delay of clinical type 1 diabetes in at-risk individuals on July 6, 2021-
Chimerix, Inc.
(CMRX)
Brincidofovir (NDA)
07/07/2021
FDA decision on Brincidofovir as a medical countermeasure for smallpox
FDA approved Brincidofovir, under brand name TEMBEXA, for the treatment of smallpox on June 4, 2021 -
ChemoCentryx Inc.
(CCXI)
Avacopan (NDA)
07/07/2021
FDA decision on Avacopan for the Treatment of ANCA-Associated Vasculitis
On Jul.6, the company announced that the FDA decision has been postponed by 3 months to Oct.7, 2021 -

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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