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
Alnylam Pharmaceuticals Inc.
(
ALNY)
OXLUMO (sNDA)
10/06/2022
FDA decision on expanded use OXLUMO for the reduction of plasma oxalate in the treatment of patients with advanced primary hyperoxaluria type 1 (PH1)
FDA approved OXLUMO for expanded use in advanced primary hyperoxaluria Type 1 on Oct.6, 2022-
scPharmaceuticals Inc.
(
SCPH)
FUROSCIX (Resubmitted NDA)
10/08/2022
FDA decision on FUROSCIX for the treatment of congestion in patients with worsening heart failure,
FDA approved FUROSCIX for the at-home treatment of congestion in Chronic Heart Failure on Oct.10, 2022-
HARROW HEALTH, INC.
(
HROW)
AMP-100 (NDA)
10/16/2022
FDA decision on AMP-100 for ocular surface anesthesia and intraoperative pain management during ocular surgery.
FDA approved AMP-100, under brand name IHEEZO, for ocular surface anesthesia on Sep.27, 2022 -
BRUKINSA (sNDA)
10/22/2022
FDA decision on BRUKINSA in the expanded use of treating adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma
On Jun.13,2022, the FDA notified the company that the decision date has been extended to Jan.20, 2023-
Daprodustat (NDA)
10/26/2022
FDA panel to review Daprodustat for the potential treatment of anaemia due to chronic kidney disease (CKD) in adult patients on dialysis and not on dialysis.
FDA panel voted 13 to 3, supporting the use of Daprodustat only in adult dialysis patients with anaemia of chronic kidney disease -
Y-mAbs Therapeutics, Inc.
(
YMAB)
OMBLASTYS (Resubmitted BLA)
10/28/2022
FDA panel to review OMBLASTYS for Neuroblastoma
FDA panel unanimously gave thumbs down to Omburtamab on Oct. 28, 2022.-
Amicus Therapeutics Inc.
(
FOLD)
Cipaglucosidase alfa, a component of AT-GAA (BLA)
10/29/2022
FDA decision on Cipaglucosidase alfa, a component of AT-GAA, for Pompe disease
On Oct.28, 2022, the FDA issued Deferred Action Letter on AT-GAA as the required manufacturing site inspection hasn't been completed yet -
Palovarotene (Resubmitted NDA)
10/31/2022
FDA panel to review Palovarotene for the prevention of heterotopic ossification in adults and children with fibrodysplasia ossificans progressiva
On Oct.25, 2022, the FDA informed its decision to postpone the planned Endocrinologic and Metabolic Drugs Advisory Committee meeting-
AstraZeneca PLC
(AZN.L,
AZN)
PT027. (NDA)
11/08/2022
FDA panel to review PT027 in proposed indication of as-needed treatment or prevention of bronchoconstriction and for the prevention of exacerbations in patients with asthma 4 years of age and older
FDA panel voted 16 to 1 that the data support a favorable benefit risk assessment for the use of PT027 for the treatment of asthma in people aged 18 years and older. In children aged 4 to 11 years, the panel voted 16 to 1 against its approval. In adolescents aged 12 to 17 years, the panel voted 9 to 8 that the data do not support a favorable benefit risk assessment for the use of PT027 for the treatment of asthma. -
Sabizabulin (EUA)
11/09/2022
FDA panel to discuss Emergency Use Authorization of Sabizabulin for hospitalized COVID-19 patients who are at high risk for ARDS.
FDA panel voted 8-5 that the known and potential benefits of Sabizabulin for the treatment of adult patients hospitalized with COVID-19 at high risk of ARDS do not outweigh its known and potential risks, on Nov. 10, 2022.-
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