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FDA Calendar

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.

Get in-depth analysis and insight on investing in the high-stakes Biotech and Pharma sectors. Check out RTT Biotech Investor and our Biotech Home Page.
Company Name
Drug
Event
Outcome
Details
Pfizer Inc.
(PFE)
Comirnaty vaccine (BLA)
Jan 2022
FDA decision on Comirnaty vaccine to prevent COVID-19
FDA approved COMIRNATY to prevent COVID-19 in individuals 16 years of age and older on Aug.23, 2021-
BioNTech
(BNTX)
Comirnaty vaccine (BLA)
Jan 2022
FDA decision on Comirnaty vaccine to prevent COVID-19
FDA approved COMIRNATY to prevent COVID-19 in individuals 16 years of age and older on Aug.23, 2021-
Amgen Inc.
(AMGN)
Tezepelumab (BLA)
Q1 2022
FDA decision on Tezepelumab in the treatment of asthma
FDA approved Tezepelumab, under brand name TEZSPIRE, for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma on Dec.17, 2021-
AstraZeneca PLC
(AZN.L, AZN)
Tezepelumab (BLA)
Q1 2022
FDA decision on Tezepelumab in the treatment of asthma
FDA approved Tezepelumab, under brand name TEZSPIRE, for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma on Dec.17, 2021-
OPKO Health Inc.
(OPK)
Somatrogon (BLA)
Jan 2022
FDA decision on Somatrogon for the treatment of pediatric patients with growth hormone deficiency
FDA issued a complete response letter for Somatrogon on Jan.21, 2022-
Pfizer Inc.
(PFE)
Somatrogon (BLA)
Jan 2022
FDA decision on Somatrogon for the treatment of pediatric patients with growth hormone deficiency
FDA issued a complete response letter for Somatrogon on Jan.21, 2022-
Xeris Pharmaceuticals Inc
(XERS)
RECORLEV (NDA)
01/01/2022
FDA decision on RECORLEV for the treatment of endogenous Cushing’s syndrome.
FDA approved Recorlev for the treatment of endogenous hypercortisolemia in adult patients with Cushing’s syndrome on Dec.30, 2021 -
Novartis AG
(NVS)
Inclisiran (Resubmitted NDA)
01/01/2022
FDA decision on Inclisiran for the treatment of hyperlipidemia in adults who have elevated low-density lipoprotein cholesterol (LDL-C) while being on a maximum tolerated dose of a statin therapy
FDA approved Inclisiran, under brand name Leqvio, to lower low-density lipoprotein cholesterol (also known as bad cholesterol or LDL-C) with two doses a year-
AstraZeneca PLC
(AZN.L, AZN)
LYNPARZA (sNDA)
Q1 2022
FDA decision on LYNPARZA as adjuvant treatment in BRCA-mutated, HER2-negative high-risk early breast cancer
-
BioXcel Therapeutics, Inc.
(BTAI)
BXCL501 (NDA)
01/05/2022
FDA decision on BXCL501 For Acute Treatment Of Agitation Associated With Schizophrenia & Bipolar Disorders I and II
On Dec.1, 2021, the FDA notified the company that the decision date has been postponed to APR.5, 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.

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