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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-
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 -
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-
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-
GlaxoSmithKline PLC
(GSK.L, GSK)
Cabotegravir (NDA)
01/24/2022
FDA decision on injectable cabotegravir long-acting for prevention of HIV
FDA approved injectable Cabotegravir long-acting, under brand name Apretude, for prevention of HIV on Dec.20, 2021 -
Pfizer Inc.
(PFE)
Cabotegravir (NDA)
01/24/2022
FDA decision on injectable cabotegravir long-acting for prevention of HIV
FDA approved injectable Cabotegravir long-acting, under brand name Apretude, for prevention of HIV on Dec.20, 2021-
Bristol-Myers Squibb Co.
(BMY)
Mavacamten (NDA)
01/28/2022
FDA decision on Mavacamten to treat symptomatic obstructive hypertrophic cardiomyopathy
On Nov.19, 2021, the FDA extended the decision date on Mavacamten to Apr.28, 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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