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.
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Company Name
Drug
Event
Outcome
Details
Biohaven Pharmaceutical Holding Co Ltd.
(
BHVN)
NURTEC ODT (sNDA)
Q2 2021
FDA decision on NURTEC ODT for the preventive treatment of migraine
-
AstraZeneca PLC
(AZN.L,
AZN)
FARXIGA (sNDA)
Q2 2021
FDA decision on FARXIGA for the treatment of new or worsening chronic kidney disease in adults with and without type 2 diabetes
-
United Therapeutics Corp
(
UTHR)
Tyvaso (sNDA)
Apr 2021
FDA decision on Tyvaso for the treatment of pulmonary hypertension associated with interstitial lung disease
FDA approved Tyvaso for the treatment of pulmonary hypertension associated with interstitial lung disease on Apr.1, 2021-
LORBRENA (sNDA)
Apr 2021
FDA decision on LORBRENA first-line treatment for people with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer
FDA approved LORBRENA as first-line treatment of people with ALK-positive non-small cell lung cancer on Mar.3, 2021-
Supernus Pharmaceuticals, Inc.
(
SUPN)
SPN-812 (Resubmitted NDA)
Early Apr 2021
FDA decision on SPN-812 for the treatment of ADHD in pediatric patients
FDA approved SPN-812 under brand name Qelbree for pediatric ADHD patients on Apr.3, 2021-
Abrocitinib (NDA)
Apr 2021
FDA decision on Abrocitinib for the treatment of moderate to severe atopic dermatitis (AD) in patients 12 and older.
On Apr.7, 2021, the FDA notified the company that the decision date has been extended by months to early Q3, 2021-
Mayne Pharma Group Limited
(MAYNF.OB)
Estelle (NDA)
Apr 2021
FDA decision on Estelle, a contraceptive product
-
AstraZeneca PLC
(AZN.L,
AZN)
Tralokinumab (BLA)
Q2 2021
FDA decision on Tralokinumab for the treatment of adults with moderate-to-severe atopic dermatiti
-
ACADIA Pharmaceuticals Inc
(
ACAD)
NUPLAZID (sNDA)
04/03/2021
FDA decision on NUPLAZID for the treatment of hallucinations and delusions associated with dementia-related psychosis
FDA issued a Complete Response Letter for NUPLAZID for the treatment of hallucinations and delusions associated with dementia-related psychosis on Apr.5, 2021-
Regeneron Pharmaceuticals
(
REGN)
Praluent (sBLA)
04/04/2021
FDA decision on the expanded use of Praluent for homozygous familial hypercholesterolemia (HoFH) in adults
-
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