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
Recro Pharma Inc.
Resubmitted IV Meloxicam (NDA)
FDA decision on resubmitted IV Meloxicam for management of moderate to severe pain
Lexicon Pharmaceuticals Inc.
Sotagliflozin (NDA)
FDA decision on Sotagliflozin for type 1 diabetes
Sotagliflozin (NDA)
FDA decision on Sotagliflozin for type 1 diabetes
Jazz Pharmaceuticals plc
Solriamfetol (NDA)
FDA decision on Solriamfetol for the treatment of excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea
FDA approves Solriamfetol
SAGE Therapeutics, Inc.
Brexanolone IV (NDA)
FDA decision on Brexanolone IV for the treatment of postpartum depression
FDA approved Zulresso (brexanolone) on Mar.19, 2019
Roche Holding AG
Tecentriq (sBLA)
FDA decision on Tecentriq in combination with Chemotherapy for the initial treatment of extensive-stage small cell lung cancer
FDA Approves Tecentriq on Mar 18
Aerie Pharmaceuticals, Inc.
Rocklatan (NDA)
FDA decision on Rocklatan for patients with open-angle glaucoma, retina diseases
FDA approves Rocklatan on Mar 12
Roche Holding AG
Tecentriq (sBLA)
FDA decision on Tecentriq in Combination with Abraxane for Initial Treatment of People with PD-L1-Positive, Metastatic Triple-Negative Breast Cancer
FDA grants accelerated approval to Tecentriq in combination with Abraxane on Mar 11
Regeneron Pharmaceuticals
Dupixent (sBLA)
FDA decision on expanded use of Dupixent as a treatment for adolescents with moderate-to-severe atopic dermatitis
FDA approves Dupixent
Johnson & Johnson
Spravato (NDA)
FDA final decision on Spravato for adults living with treatment-resistant depression
FDA approves SPRAVATO on Mar 5
Novartis AG
Siponimod (NDA)
FDA decision on Siponimod for secondary progressive multiple sclerosis in adults
Mar 2019
Novo Nordisk A/S
FDA decision on N8-GP for treatment of people with haemophilia A
FDA approveD ESPEROCT on Feb 19, 2019
Karyopharm Therapeutics Inc.
Selinexor (NDA)
FDA panel to review Selinexor for the treatment of patients with refractory multiple myeloma who have received at least three prior therapies
FDA panel voted 8 to 5 recommending that the FDA wait for Phase 3 study results of Selinexor
Bausch Health Companies Inc.
Loteprednol etabonate ophthalmic gel (NDA)
FDA decision on Loteprednol etabonate ophthalmic gel for post-operative inflammation and pain following ocular surgery
FDA approves LOTEMAX SM (loteprednol etabonate ophthalmic gel) for the treatment of postoperative inflammation and pain following ocular surgery
Incyte Corporation
Ruxolitinib (sNDA)
FDA decision on Ruxolitinib for the treatment of steroid-refractory acute GVHD

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