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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)
-
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
FDA issued a Complete Response Letter for Tenapanor on Jul.29, 2021-
Sol-Gel Technologies Ltd.
(SLGL)
Twyneo (NDA)
08/01/2021
FDA decision on Twyneo for the treatment of acne vulgaris
FDA approved Twyneo for the treatment of acne vulgaris on Jul.27, 2021-
Pfizer Inc.
(PFE)
TicoVac (BLA)
Aug 2021
FDA decision on TicoVac vaccine for tick-borne encephalitis
-
Pacira Pharmaceuticals, Inc.
(PCRX)
EXPAREL 200-liter process (sNDA)
08/06/2021
FDA decision on EXPAREL 200-liter process 
-
Eton Pharmaceuticals, Inc
(ETON)
Topiramate oral solution (NDA)
08/06/2021
FDA decision on Topiramate for 3 indications
-
Medexus Pharmaceuticals Inc.
(MEDXF.OB)
Treosulfan (NDA)
08/11/2021
FDA decision on Treosulfan for using in conditioning treatment for patients undergoing allogeneic hematopoietic stem cell transplantation
FDA issues Complete Response Letter for treosulfan for using in conditioning treatment for patients undergoing allogeneic hematopoietic stem cell transplantation on August 03, 2021.-
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
FDA approved Sotorasib, under brand name LUMAKRAS for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer on May 28, 2021-
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
FDA approved 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 on Jul.9, 2021-

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