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
Urovant Sciences Ltd.
Vibegron (NDA)
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.
MYL-1402O (BLA)
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
Arbaclofen ER (Resubmitted NDA)
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.
FDA decision on TRIKAFTA for the treatment of cystic fibrosis patients with additional rare CFTR mutations
Vertex Pharmaceuticals Inc.
FDA decision on SYMDEKO for the treatment of cystic fibrosis patients with additional rare CFTR mutations
Vertex Pharmaceuticals Inc.
FDA decision on KALYDECO for the treatment of cystic fibrosis patients with additional rare CFTR mutations
scPharmaceuticals Inc.
FUROSCIX (Resubmitted NDA)
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.
Tirbanibulin Ointment (NDA)
FDA decision on Tirbanibulin Ointment for the treatment of actinic keratosis
Roche Holding AG
Xolair (sBLA)
Q1 2021
FDA decision on Xolair for self-administration across all indications
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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