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
Regeneron Pharmaceuticals
(
REGN)
Evkeeza (sBLA)
03/30/2023
FDA decision on Evkeeza as an adjunct to other lipid-lowering therapies to treat children aged 5 to 11 years with homozygous familial hypercholesterolemia
FDA extends approval of Evkeeza to treat children aged 5 to 11 years with homozygous familial hypercholesterolemia on March 22,2023-
Biomarin Pharmaceutical Inc.
(
BMRN)
Valoctocogene Roxaparvovec (Resubmitted BLA)
03/31/2023
FDA decision on Valoctocogene Roxaparvovec for the treatment of severe hemophilia A in adult patients
FDA Extends PDUFA Target Action Date to June 30, 2023-
Emergent BioSolutions Inc
(
EBS)
AV7909 (BLA)
Apr 2023
FDA decision on AV7909 for post-exposure prophylaxis of Anthrax following suspected or confirmed exposure to Bacillus anthracis
Pending-
Ritlecitinib (NDA)
Q2 2023
FDA decision on Ritlecitinib for the treatment of alopecia areata in 12 years and older patients
Pending-
PREVNAR 20 Vaccine (sBLA)
Apr 2023
FDA decision on PREVNAR 20 Vaccine for use in infants and children 6 weeks through 17 years of age, and for the prevention of otitis media
Pending-
Natalizumab (BLA)
Q2 2023
FDA decision on Natalizumab, the first-of-a-kind biosimilar to Tysabri
Pending-
Polivy (sBLA)
04/02/2023
FDA decision on Polivy in combination with Rituxan plus cyclophosphamide, doxorubicin and prednisone for the treatment of people with previously untreated diffuse large B-cell lymphoma
Pending-
AVT02 (BLA)
04/13/2023
FDA decision on AVT02 as biosimilar to Humira
Pending-
PADCEV with KEYTRUDA (sBLAs)
04/21/2023
FDA decision on PADCEV with KEYTRUDA for the first-line treatment of certain patients with locally advanced or metastatic urothelial cancer
FDA approved PADCEV in combination with KEYTRUDA for the treatment of patients with locally advanced or metastatic urothelial cancer, on Dec. 20, 2022-
Astellas Pharma Inc.
(
ALPMY,
ALPMY)
PADCEV with KEYTRUDA (sBLAs)
04/21/2023
FDA decision on PADCEV with KEYTRUDA for the first-line treatment of certain patients with locally advanced or metastatic urothelial cancer
FDA approved PADCEV in combination with KEYTRUDA for the treatment of patients with locally advanced or metastatic urothelial cancer, on Dec. 20, 2022-
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.
How to Read an FDA Calendar?
Before you can use an FDA Calendar, it's important to understand how to read and interpret it. An FDA Calendar typically displays information about the expected timeline for a particular drug approval or PDUFA date. The calendar will also provide key information such as what type of approval is being sought (e.g. full approval, tentative approval, accelerated approval), and any publicly available information about the expected decision date.