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
Ligand Pharmaceuticals Inc
(
LGND)
Sparsentan(NDA)
02/17/2023
FDA decision on Sparsentan for the treatment of IgA nephropathy
FDA granted accelerated approval for Sparsentan, under brand name FILSPARI, to reduce proteinuria in adults with primary IgAN, on Feb.18, 2023-
Radius Health, Inc.
(
RDUS)
Elacestrant (NDA)
02/17/2023
FDA decision on Elacestrant for treatment of ER+/HER2- advanced or metastatic breast cancer
FDA approved Elacestrant, under brand name Orserdu, for treatment of ER+/HER2- advanced or metastatic breast cancer on Jan.27, 2023-
Apellis Pharmaceuticals, Inc.
(
APLS)
Syfovre (pegcetacoplan injection) (NDA)
02/26/2023
FDA decision on Pegcetacoplan for the treatment of Geographic Atrophy secondary to age-related macular degeneration
FDA approves Syfovre (pegcetacoplan injection) for Geographic Atrophy secondary to age-related macular degeneration on Feb 17, 2023-
ABRYSVO (BLA)
02/28/2023
FDA panel to review ABRYSVO RSVpreF for active immunization for the prevention of acute respiratory disease and lower respiratory tract disease (LRTD) caused by respiratory syncytial virus in adults 60 years of age and older
FDA panel voted 7 to 4 on safety and 7 to 4 on effectiveness, recommending approval of ABRYSVO RSVpreF vaccine to help combat RSV in older adults on Feb.28, 2023. -
Royalty Pharma plc
(
RPRX)
Omecamtiv mecarbil (NDA)
02/28/2023
FDA decision on Omecamtiv mecarbil for heart failure with reduced ejection fraction (HFrEF)
FDA declined to approve Omecamtiv mecarbil for the treatment of heart failure with reduced ejection fraction on Feb.28, 2023-
Efanesoctocog alfa (BIVV001) (BLA)
02/28/2023
FDA decision on efanesoctocog alfa for the treatement of hemophilia A
FDA approved Efanesoctocog alfa under brand name ALTUVIIIO on Feb.24, 2023-
Reata Pharmaceuticals, Inc.
(
RETA)
Omaveloxolone (NDA)
02/28/2023
FDA decision on Omaveloxolone for the treatment of patients with Friedreich’s Ataxia
FDA approved Omaveloxolone, under brand name SKYCLARYS, for the treatment of Friedreich’s ataxia in adults and adolescents aged 16 years and older on Feb.28, 2023-
Omecamtiv mecarbil (NDA)
02/28/2023
FDA decision on Omecamtiv mecarbil for heart failure with reduced ejection fraction (HFrEF)
FDA denies FDA approval for Omecamtiv mecarbil for the treatment of heart failure with reduced ejection fraction on Feb.28, 2023-
Regeneron Pharmaceuticals
(
REGN)
EYLEA (sBLA)
02/28/2023
FDA decision to approve EYLEA for every 16-week dosing regimen in patients with Diabetic Retinopathy
Pending-
AREXVY (BLA)
03/01/2023
FDA panel to review AREXVY for active immunization for the prevention of lower respiratory tract disease caused by respiratory syncytial virus RSV-A and RSV-B subtypes in adults 60 years of age and older
FDA panel voted unanimously recommending approval of Arexvy for prevention of RSV-linked lower respiratory tract disease in adults 60 years of age and older on Mar.1, 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.