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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
Zai Lab Limited
(ZLAB)
Retifanlimab (BLA)
07/25/2021
FDA decision on retifanlimab as a potential treatment for adult patients with locally advanced or metastatic squamous cell carcinoma of anal canal (SCAC)
-
Iterum Therapeutics plc
(ITRM)
Oral sulopenem (NDA)
07/25/2021
FDA decision on Oral sulopenem for the treatment of uncomplicated urinary tract infections
-
Incyte Corporation
(INCY)
Retifanlimab (BLA)
07/25/2021
FDA decision on retifanlimab as a potential treatment for adult patients with locally advanced or metastatic squamous cell carcinoma of anal canal (SCAC)
-
Ardelyx, Inc
(ARDX)
Tenapanor (NDA)
07/29/2021
FDA decision on Tenapanor for control of serum phosphorus in adult patients with chronic kidney disease on dialysis
-
Sol-Gel Technologies Ltd.
(SLGL)
Twyneo (NDA)
08/01/2021
FDA decision on Twyneo for the treatment of acne vulgaris
-
Pfizer Inc.
(PFE)
TicoVac (BLA)
Aug 2021
FDA decision on TicoVac vaccine for tick-borne encephalitis
-
Eton Pharmaceuticals, Inc
(ETON)
Topiramate oral solution (NDA)
08/06/2021
FDA decision on Topiramate for 3 indications
-
Jazz Pharmaceuticals plc
(JAZZ)
Xywav (sNDA)
08/12/2021
Final FDA decision on Xywav oral solution in adult patients with idiopathic hypersomnia
-
Amgen Inc.
(AMGN)
Sotorasib (NDA)
08/16/2021
FDA decision on Sotorasib for the treatment of patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer
-
Astellas Pharma Inc.
( ALPMY, ALPMY)
PADCEV (sBLA)
08/17/2021
FDA decision to expand the use of PADCEV in patients with locally advanced or metastatic urothelial cancer who have been previously treated with a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and are ineligible for cisplatin
-

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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