FDA Calendar

PDUFA dates and FDA Panel Review dates are very important because they are make or break events for biostocks when the decisions are announced. Also, usually biostocks experience a run-up going into the scheduled decision/review dates. So having prior knowledge of the catalysts goes a long way toward maximizing profit or minimizing loss while trading volatile biotech stocks.
Listed below are large cap, mid cap and small cap stocks with pending regulatory catalysts.

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Company Name
Intra-Cellular Therapies, Inc.
Lumateperone (NDA)
FDA decision on Lumateperone for the treatment of schizophrenia
POSIMIR (Resubmitted NDA)
FDA decision on POSIMIR for post-operative pain relief depot product
Alkermes plc
Vumerity (diroximel fumarate) (NDA)
FDA decision on diroximel fumarate for Relapsing Remitting Multiple Sclerosis
AV001 (NDA)
FDA decision on AV001 for Hospital product
Acceleron Pharma, Inc
Luspatercept (BLA)
FDA decision on Luspatercept for adult patients with beta-thalassemia-associated anemia
Celgene Corporation
Luspatercept (BLA)
FDA decision on Luspatercept for the treatment of MDS and Beta-Thalassemia-Associated Anemias
Roche Holding AG
Tecentriq (sBLA)
FDA decision on Tecentriq plus chemotherapy in metastatic non-squamous non-small cell lung cancer
Aquestive Therapeutics Inc.
Riluzole Oral Film (NDA)
FDA decision on Riluzole Oral Film as an adjunctive therapy in the treatment of amyotrophic lateral sclerosis
Agile Therapeutics Inc.
Twirla (Resubmitted NDA)
FDA decision on Twirla for use as a low-dose combined hormonal contraceptive patch
Amarin Corp Plc
Vascepa (sNDA)
FDA panel to review expansion of Vascepa labeling based on the REDUCE-IT cardiovascular outcomes study
Lipocine Inc
TLANDO (resubmitted NDA)
FDA decision on TLANDO as testosterone replacement therapy in adult males for conditions associated with hypogonadism
Roche Holding AG
Xofluza (sNDA)
FDA decision on Xofluza for the treatment of influenza in people at high risk of complications
RedHill Biopharma Ltd.
Talicia (NDA)
FDA decision on Talicia for treatment of H. pylori infection.
Adamis Pharmaceuticals Corp
ZIMHI (naloxone) Injection (NDA)
FDA decision on ZIMHI for the treatment of opioid overdose
Agile Therapeutics Inc.
Twirla (Resubmitted NDA)
FDA panel to review Twirla for use as a low-dose combined hormonal contraceptive patch
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