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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
GENMAB A/S
(GMAB)
Epcoritamab (BLA)
05/21/2023
FDA decision on Epcoritamab for the treatment of patients with relapsed/refractory large B-cell lymphoma
FDA approved Epcoritamab, under the brand name Epkinly, for the treatment of patients with relapsed/refractory large B-cell lymphoma on May 19, 2023-
Blueprint Medicines
(BPMC)
AYVAKIT (sNDA)
05/22/2023
FDA decision on AYVAKIT (avapritinib) for adults with indolent systemic mastocytosis (SM)
FDA approved Ayvakit for the treatment of adults with indolent systemic mastocytosis on May 22, 2023-
ImmunityBio, Inc
(IBRX)
Anktiva (BLA)
05/23/2023
FDA decision on Anktiva (N-803) for the treatment of patients with BCG-unresponsive non-muscle-invasive bladder cancer carcinoma in situ
FDA denied approval for Anktiva and issued a issued a complete response letter on May 9, 2023-
Lexicon Pharmaceuticals Inc.
(LXRX)
Sotagliflozin (NDA)
05/27/2023
FDA decision on Sotagliflozin for the treatment of heart failure
FDA approved Sotagliflozin, under brand name INPEFA, for treatment of Heart Failure on May 26, 2023-
Innoviva, Inc.
(INVA)
Sulbactam-durlobactam (NDA)
05/29/2023
FDA decision on Sulbactam-durlobactam for the treatment of adults with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex (Acinetobacter
FDA approved XACDURO (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use for the treatment of adults with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex on May 23, 2023-
Zai Lab Limited
(ZLAB)
sulbactam-durlobactam (SUL-DUR) (NDA)
05/29/2023
FDA decision on SUL-DUR for Infections Caused by Acinetobacter baumannii
FDA approved XACDURO (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use for the treatment of adults with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex on May 23, 2023-
AVADEL PHARMACEUTICALS PLC
(AVDL)
FT218 (NDA)
Jun 2023
FDA decision on FT218 for the treatment of excessive daytime sleepiness or cataplexy in adults with narcolepsy
FDA grants final approval for LUMRYZ (FT218) for excessive daytime sleepiness or cataplexy in adults with narcolepsy on May 1, 2023-
Merck & Co Inc.
(MRK)
PREVYMIS (sNDA)
06/05/2023
FDA decision on expanded use of PREVYMIS for prophylaxis of cytomegalovirus (CMV) disease in adult kidney transplant recipients at high risk (D+/R-)
Pending-
Sanofi
( SNYNF, SNY)
Nirsevimab (BLA)
06/08/2023
FDA panel to review Nirsevimab for the prevention of RSV lower respiratory tract disease in infants and children up to age 24 months
Pending-
AstraZeneca PLC
(AZN.L, AZN)
Nirsevimab (BLA)
06/08/2023
FDA panel to review Nirsevimab for the prevention of RSV lower respiratory tract disease in infants and children up to age 24 months
-

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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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.



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