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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
Arcutis Biotherapeutics Inc.
(ARQT)
Roflumilast Cream (NDA)
07/29/2022
FDA decision on Roflumilast Cream for the treatment of psoriasis in adults and adolescents
FDA approved Roflumilast Cream, under brand name ZORYVE, for the treatment of plaque psoriasis on Jul.29, 2022 -
Coherus Biosciences, Inc.
(CHRS)
CHS-201 (BLA)
08/02/2022
FDA decision on CHS-201, a biosimilar candidate of Lucentis
FDA approved CIMERLI, formerly CHS-201, as a biosimilar product interchangeable with Lucentis on Aug.3, 2022 -
Regeneron Pharmaceuticals
(REGN)
Dupixent (sBLA)
08/03/2022
FDA decision on Dupixent in the expanded use of treating adult and pediatric patients aged 12 years and older with eosinophilic esophagitis
FDA approved Dupixent as first treatment for adults and children aged 12 and older with eosinophilic esophagitis on May 20, 2022-
Sanofi
( SNYNF, SNY)
Dupixent (sBLA)
08/03/2022
FDA decision on Dupixent in the expanded use of treating adult and pediatric patients aged 12 years and older with eosinophilic esophagitis
FDA approved Dupixent as first treatment for adults and children aged 12 and older with eosinophilic esophagitis on May 20, 2022-
ACADIA Pharmaceuticals Inc
(ACAD)
NUPLAZID (Resubmitted sNDA)
08/04/2022
FDA decision on NUPLAZID for the expanded use in treatment of hallucinations and delusions associated with Alzheimer’s disease psychosis
FDA declines to approve NUPLAZID for the expanded use in treatment of hallucinations and delusions associated with Alzheimer’s disease psychosis on Aug.5, 2022 -
ACADIA Pharmaceuticals Inc
(ACAD)
Pimavanserin (Resubmitted sNDA)
08/04/2022
FDA decision on the expanded use of Pimavanserin for the treatment of hallucinations and delusions associated with Alzheimer’s disease psychosis
-
Eton Pharmaceuticals, Inc
(ETON)
Biorphen (Prior Approval Supplement)
08/04/2022
FDA decision to convert Biorphen from an ampule to a vial container.
-
Myovant Sciences Ltd
(MYOV)
MYFEMBREE (sNDA)
08/06/2022
FDA decision on MYFEMBREE for management of moderate to severe pain associated with endometriosis.
FDA approved MYFEMBREE for management of moderate to severe pain associated with endometriosis on Aug.6, 2022-
Pfizer Inc.
(PFE)
MYFEMBREE (sNDA)
08/06/2022
FDA decision on MYFEMBREE for management of moderate to severe pain associated with endometriosis.
FDA approved MYFEMBREE for management of moderate to severe pain associated with endometriosis on Aug.6, 2022-
bluebird bio Inc.
(BLUE)
Betibeglogene autotemcel (beti-cel) (BLA)
08/19/2022
FDA decision on Beti-cel gene therapy for patients with ß-thalassemia who require regular Red Blood cell transfusions
-

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