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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 our premium biotech research product and our biotech home page.
Company Name
Drug
Event
Outcome
Details
Urovant Sciences Ltd.
(UROV)
Vibegron (NDA)
12/26/2020
FDA decision on Vibegron for the treatment of overactive bladder
FDA approved Vibegron, under brand name GEMTESA, for the treatment of overactive bladder, on Dec.23, 2020-
Viatris Inc.
(VTRS)
MYL-1402O (BLA)
12/27/2020
FDA decision on MYL-1402O as a biosimilar to Roche's Avastin
The company has been notified that inspection of the manufacturing facility is necessary before MYL-1402O could be approved. The decision has been deferred-
Osmotica Pharmaceutical Corp
(OSMT)
Arbaclofen ER (Resubmitted NDA)
12/29/2020
FDA decision on Arbaclofen ER for the treatment of spasticity in patients with MS
FDA issued a Complete Response Letter on Dec.29, 2020. The company has been asked to conduct a new study to provide substantial evidence of efficacy of Arbaclofen -
Vertex Pharmaceuticals Inc.
(VRTX)
TRIKAFTA (sNDA)
12/30/2020
FDA decision on TRIKAFTA for the treatment of cystic fibrosis patients with additional rare CFTR mutations
-
Vertex Pharmaceuticals Inc.
(VRTX)
SYMDEKO (sNDA)
12/30/2020
FDA decision on SYMDEKO for the treatment of cystic fibrosis patients with additional rare CFTR mutations
-
Vertex Pharmaceuticals Inc.
(VRTX)
KALYDECO (sNDA)
12/30/2020
FDA decision on KALYDECO for the treatment of cystic fibrosis patients with additional rare CFTR mutations
-
scPharmaceuticals Inc.
(SCPH)
FUROSCIX (Resubmitted NDA)
12/30/2020
FDA decision on FUROSCIX or the treatment of worsening heart failure due to congestion
FDA issued Complete Response Letter for FUROSCIX on Dec.7-
Athenex, Inc.
(ATNX)
Tirbanibulin Ointment (NDA)
12/30/2020
FDA decision on Tirbanibulin Ointment for the treatment of actinic keratosis
-
Roche Holding AG
(RHHBY)
Xolair (sBLA)
Q1 2021
FDA decision on Xolair for self-administration across all indications
-
AbbVie
(ABBV)
Botox (sBLA)
Q1 2021
FDA decision on BOTOX for the treatment of pediatric patients with neurogenic detrusor overactivity
-

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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