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
Omidubicel (BLA)
05/01/2023
FDA decision on Omidubicel, an allogeneic hematopoietic stem cell (bone marrow) transplant for patients with blood cancers.
FDA approved Omidubicel, under brand name Omisirge, on Apr.18, 2023-
ARS Pharmaceuticals, Inc.
(
SPRY)
Neffy (NDA)
Mid 2023
FDA decision on Neffy (intranasal epinephrine) for the emergency treatment of severe type I allergic reactions in children and adults weighing 30 kg (66 pounds) or more.
Pending-
PAXLOVID (NDA)
May 2023
FDA decision on COVID-19 oral treatment, PAXLOVID
FDA approved PAXLOVID for treatment of COVID-19 in adults on May 25, 2023-
ABRYSVO RSVpreF vaccine (BLA)
May 2023
FDA decision on ABRYSVO RSVpreF vaccine to help combat RSV in older adults
Pending-
AREXVY Respiratory Syncytial Virus Older Adult Vaccine (BLA)
05/03/2023
FDA decision on AREXVY Respiratory Syncytial Virus Vaccine to help protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection
FDA approved AREXVY on May 3, 2022-
MydCombi (Resubmitted NDA)
05/08/2023
FDA decision on MydCombi ophthalmic spray for the treatment of Mydriasis
FDA approved Mydcombi for inducing mydriasis on May 8, 2023-
Protalix BioTherapeutics Inc.
(
PLX)
Pegunigalsidase alfa (Resubmitted BLA)
05/09/2023
FDA decision on Pegunigalsidase alfa for the treatment of adult patients with Fabry disease
FDA approved Pegunigalsidase alfa-iwx, under brand name ELFABRIO, for the treatment of adult patients with Fabry disease on May 10, 2023.-
Lundbeck
(HLUKF.OB)
Brexpiprazole (sNDA)
05/10/2023
FDA decision on Brexpiprazole for the expanded use in treating gitation associated with Alzheimer’s dementia
FDA approved Rexulti (brexpiprazole) for the expanded use in treating gitation associated with Alzheimer’s dementia on May 11, 2023-
ARS Pharmaceuticals, Inc.
(
SPRY)
Neffy (NDA)
05/11/2023
FDA panel to review Neffy (intranasal epinephrine) for the emergency treatment of severe type I allergic reactions in children and adults weighing 30 kg (66 pounds) or more.
FDA panel voted 16-6 recommending Neffy for adults and 16-5 recommending it for children on May 11, 2023-
Sarepta Therapeutics
(
SRPT)
SRP-9001 (BLA)
05/12/2023
FDA panel to review SRP-9001 as a treatment for Duchenne muscular dystrophy.
FDA panel voted 8 to 6 in support of accelerated approval of SRP-9001 for the treatment of ambulatory patients with Duchenne muscular dystrophy with a confirmed mutation in the DMD gene on May 12, 2023-
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.