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
Flexion Therapeutics, Inc.
FDA decision on the repeat administration of ZILRETTA for patients with osteoarthritis knee pain
Intra-Cellular Therapies, Inc.
Lumateperone (NDA)
FDA decision on Lumateperone for the treatment of schizophrenia
Celgene Corporation
Fedratinib (NDA)
FDA decision on Fedratinib for myelofibrosis
Roche Holding AG
Tecentriq (sBLA)
FDA decision on Tecentriq plus chemotherapy in metastatic non-squamous non-small cell lung cancer
Nabriva Therapeutics
Lefamulin (NDA)
FDA decision on oral and IV formulations of Lefamulin for bacterial pneumonia
FDA decision on HETLIOZ for the expanded indication of jet lag disorder
Karyopharm Therapeutics Inc.
Selinexor (NDA)
FDA decision on Selinexor for patients with refractory multiple myeloma
Dova Pharmaceuticals, Inc.
FDA decision on DOPTELET for chronic immune thrombocytopenia
Regeneron Pharmaceuticals
Dupixent (sBLA)
FDA decision on Dupixent for severe chronic rhinosinusitis with nasal polyps
Agios Pharmaceuticals, Inc.
FDA decision on TIBSOVO for newly diagnosed acute myeloid leukemia with IDH1 mutation
Merck & Co Inc.
FDA decision on KEYTRUDA as Monotherapy or in combination with Chemotherapy
Nektar Therapeutics
NKTR-181 (NDA)
FDA decision on NKTR-181 for chronic low back pain in adult patients new to opioid therapy
Incyte Corporation
Ruxolitinib (sNDA)
FDA decision on Ruxolitinib for the treatment of steroid-refractory acute GVHD
Heron Therapeutics Inc.
HTX-011 (NDA)
FDA decision on HTX-011 for postoperative pain management
Heron Therapeutics Inc.
HTX-011 (NDA)
FDA decision on HTX-011 for the management of postoperative pain

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