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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
CorMedix Inc.
(CRMD)
DefenCath (Resubmitted NDA)
08/28/2022
FDA decision on DefenCath as catheter lock solution for the reduction of catheter-related bloodstream infections (CRBSIs) in patients with renal failure who are receiving chronic hemodialysis via a central venous catheter
FDA issued Complete Response Letter for DefenCath on Aug 8, 2022 -
Amicus Therapeutics Inc.
(FOLD)
Miglustat a component of AT-GAA (NDA)
08/29/2022
FDA decision on Miglustat for the treatment of Pompe disease
-
Incyte Corporation
(INCY)
Parsaclisib (NDA)
08/30/2022
FDA decision on Parsaclisib for the treatment of adult patients with relapsed or refractory follicular lymphoma who have received at least two prior systemic therapies
The company withdrew the NDA for Parsaclisib seeking approval in the treatment of adult patients with relapsed or refractory follicular lymphoma who have received at least two prior systemic therapies in Jan.2022-
Bayer AG
(BAYZF.PK, BAYRY.PK, BYR.L)
NUBEQA (sNDA)
09/03/2022
FDA decision on NUBEQA in combination with Docetaxel for the treatment of metastatic hormone-sensitive prostate cancer
FDA approved NUBEQA in combination with Docetaxel for adult patients with metastatic hormone-sensitive prostate cancer on Aug.8, 2022-
Amylyx Pharmaceuticals, Inc
(AMLX)
AMX0035 (NDA)
09/07/2022
FDA panel to review AMX0035 for the treatment of amyotrophic lateral sclerosis
FDA advisory committee voted 7-2 in favor of oral drug AMX0035 for the treatment of amyotrophic lateral sclerosis on Sept. 7, 2022-
Revance Therapeutics, Inc.
(RVNC)
DaxibotulinumtoxinA Injection (resubmitted BLA)
09/08/2022
FDA decision on DaxibotulinumtoxinA for the treatment of moderate to severe glabellar lines
FDA approved DaxibotulinumtoxinA, under brand name DAXXIFY, on Sep.8-
Spectrum Pharmaceuticals Inc
(SPPI)
Eflapegrastim (resubmitted BLA)
09/09/2022
FDA decision on Eflapegrastim for the treatment of chemotherapy-induced neutropenia
FDA approved Eflapegrastim, under brand name ROLVEDON, on Sep.9, 2022 -
Bristol-Myers Squibb Co.
(BMY)
Deucravacitinib (NDA)
09/10/2022
FDA decision on Deucravacitinib for the Treatment of Moderate to Severe Plaque Psoriasis
FDA approved Deucravacitinib, under the brand name Sotyktu, for the treatment of adults with moderate-to-severe plaque psoriasis, on Sep.9, 2022-
ObsEva SA
(OBSV)
Linzagolix (NDA)
09/13/2022
FDA decision on Linzagolix for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women
-
bluebird bio Inc.
(BLUE)
Elivaldogene autotemcel (eli-cel) (BLA)
09/16/2022
FDA decision on Eli-cel for cerebral adrenoleukodystrophy
FDA approves Eli-cel for cerebral adrenoleukodystrophy on Sep. 16, 2022-

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