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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
HARROW HEALTH, INC.
(HROW)
AMP-100 (NDA)
10/16/2022
FDA decision on AMP-100 for ocular surface anesthesia and intraoperative pain management during ocular surgery.
-
BeiGene
(BGNE)
BRUKINSA (sNDA)
10/22/2022
FDA decision on BRUKINSA in the expanded use of treating adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma
On Jun.13,2022, the FDA notified the company that the decision date has been extended to Jan.20, 2023-
GSK plc
(GSK.L, GSK)
Daprodustat (NDA)
10/26/2022
FDA panel to review Daprodustat for the potential treatment of anaemia due to chronic kidney disease (CKD) in adult patients on dialysis and not on dialysis.
-
Y-mAbs Therapeutics, Inc.
(YMAB)
OMBLASTYS (Resubmitted BLA)
10/28/2022
FDA panel to review OMBLASTYS for Neuroblastoma
-
Amicus Therapeutics Inc.
(FOLD)
Cipaglucosidase alfa, a component of AT-GAA (BLA)
10/29/2022
FDA decision on Cipaglucosidase alfa, a component of AT-GAA, for Pompe disease
-
Ipsen SA
(IPSEY)
Palovarotene (Resubmitted NDA)
10/31/2022
FDA panel to review Palovarotene for the prevention of heterotopic ossification in adults and children with fibrodysplasia ossificans progressiva
-
AstraZeneca PLC
(AZN.L, AZN)
PT027. (NDA)
11/08/2022
FDA panel to review PT027 in proposed indication of as-needed treatment or prevention of bronchoconstriction and for the prevention of exacerbations in patients with asthma 4 years of age and older
-
Ardelyx, Inc
(ARDX)
XPHOZAH (NDA)
11/16/2022
FDA panel to review XPHOZAH for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis.
-
Travere Therapeutics Inc
(TVTX)
Sparsentan(NDA)
11/17/2022
FDA decision on Sparsentan for the treatment of IgA nephropathy
-
Provention Bio, Inc.
(PRVB)
Teplizumab (Resubmitted BLA)
11/17/2022
FDA decision on Teplizumab for the delay of type 1 diabetes (T1D).
-

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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