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FDA Calendar

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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
Ticker
Drug
Event
Date
Outcome
Details
Clinuvel Pharmaceuticals Limited
CUV.AX, CLVLY.PK, CLVLF.PK
SCENESSE(NDA)
FDA decision on SCENESSE in the prevention of phototoxicity and anaphylactoid reactions in adult patients with erythropoietic protoporphyria
07/08/2019
Karyopharm Therapeutics Inc.
Selinexor (NDA)
FDA decision on Selinexor for patients with refractory multiple myeloma
07/06/2019
Dova Pharmaceuticals, Inc.
DOPTELET (sNDA)
FDA decision on DOPTELET for chronic immune thrombocytopenia
06/30/2019
Retrophin Inc.
Thiola (NDA)
FDA decision on new formulation of Thiola in the treatment of cystinuria
06/30/2019
Alexion Pharmaceuticals Inc.
Soliris (sNDA)
FDA decision on Soliris for the treatment of neuromyelitis optica spectrum disorder
06/28/2019
Celgene Corporation
REVLIMID (sNDA)
FDA decision on REVLIMID in combination with Rituximab for the treatment of patients with previously treated follicular and marginal zone lymphom
06/27/2019
FDA Approves REVLIMID on May 28
Regeneron Pharmaceuticals
Dupixent (sBLA)
FDA decision on Dupixent for severe chronic rhinosinusitis with nasal polyps
06/26/2019
Acer Therapeutics Inc.
EDSIVO (NDA)
FDA decision on EDSIVO for the treatment of vascular Ehlers-Danlos syndrome
06/25/2019
AMAG Pharmaceuticals Inc.
Vyleesi (NDA)
FDA decision on Vyleesi for the treatment of hypoactive sexual desire disorder in pre-menopausal women
06/23/2019
Agios Pharmaceuticals, Inc.
TIBSOVO (sNDA)
FDA decision on TIBSOVO for newly diagnosed acute myeloid leukemia with IDH1 mutation
06/21/2019
FDA approved TIBSOVO for newly diagnosed acute myeloid leukemia with IDH1 mutation on May 2, 2019
Merck & Co Inc.
Keytruda (sBLA)
FDA decision on Keytruda as monotherapy for the treatment of patients with advanced small-cell lung cancer
06/17/2019
FDA Approves EYTRUDA
Merck & Co Inc.
Keytruda (sBLA)
FDA decision on Keytruda as monotherapy or in combination with chemotherapy for the first-line treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma
06/10/2019
FDA Approves KEYTRUDA on June 11
Xeris Pharmaceuticals Inc
Gvoke HypoPen(NDA)
FDA decision on Gvoke HypoPen for the treatment of severe hypoglycemi
06/10/2019
Merck & Co Inc.
KEYTRUDA (sBLA)
FDA decision on KEYTRUDA as Monotherapy or in combination with Chemotherapy
06/10/2019
FDA Approves KEYTRUDA on June 11
Merck & Co Inc.
ZERBAXA (sNDA)
FDA decision on ZERBAXA to treat adult patients with nosocomial pneumonia
06/03/2019
FDA approves ZERBAXA


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