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
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
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
FDA decision extended by 3 months to May 24, 2019.
Stemline Therapeutics Inc
FDA decision on ELZONRIS for the treatment of blastic plasmacytoid dendritic cell neoplasm
FDA approved ELZONRIS on Dec.21, 2018
Alexion Pharmaceuticals Inc.
ALXN1210 (BLA)
FDA decision on ALXN1210 for the treatment of patients with paroxysmal nocturnal hemoglobinuria
FDA approved Ultomiris (also known as ALXN1210) on Dec.21
Merck & Co Inc.
FDA decision on KEYTRUDA in the treatment of resected, high-risk stage III melanoma
FDA Approves KEYTRUDA on Feb 19
Bausch Health Companies Inc.
DUOBRII (Resubmitted NDA)
FDA decision on DUOBRII for the topical treatment of plaque psoriasis.
Iclaprim (NDA)
FDA decision on Iclaprim for acute bacterial skin and skin structure infections
FDA declines to approve Iclaprim for ABSSSI
Johnson & Johnson
Esketamine (NDA)
FDA panel to review Esketamine for the treatment of treatment-resistant depression.
FDA panel backs Esketamine for the treatment of treatment-resistant depression.
Evolus Inc.
DWP-450(Resubmitted BLA)
FDA decision on DWP-450 for treatment of moderate to severe glabellar lines
FDA approved Jeuveau (DWP-450) for treatment of moderate to severe glabellar lines on Feb.1, 2019
Alkermes plc
ALKS 5461 (NDA)
FDA’s final decision on ALKS 5461 for adjunctive treatment of major depressive disorder
FDA rejected ALKS 5461 for adjunctive treatment of major depressive disorder on Feb.1, 2019

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