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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
Incyte Corporation
Capmatinib (NDA)
FDA decision on Capmatinib for Advanced Non-Small Cell Lung Cancer
08/17/2020
FDA granted accelerated approval for Capmatinib under brand name TABRECTA on May 6, 2020
Jazz Pharmaceuticals plc
Lurbinectedin (NDA)
FDA decision on lurbinectedin for patients with SCLC who have progressed after prior platinum-containing therapy
08/16/2020
Deciphera Pharmaceuticals, Inc.
Ripretinib (NDA)
FDA decision on Ripretinib for advanced gastrointestinal stromal tumors
08/13/2020
FDA approved ripretinib under brand name QINLOCK for adult patients with advanced gastrointestinal stromal tumors on May 15, 2020
Gilead Sciences Inc.
KTE-X19 (BLA)
FDA decision on KTE-X19 for the treatment of adult patients with relapsed or refractory mantle cell lymphoma
08/10/2020
Fennec Pharmaceuticals Inc
PEDMARK (NDA)
FDA decision on PEDMARK for the prevention of Cisplatin-induced hearing loss
08/10/2020
Trevena, Inc.
IV Oliceridine (Resubmitted NDA)
FDA decision on IV Oliceridine for the management of moderate-to-severe acute pain
08/07/2020
Bristol-Myers Squibb Co.
Opdivo plus Yervoy (sBLA)
FDA decision on Opdivo plus Yervoy, combined with limited chemotherapy in first-line lung cancer
08/06/2020
FDA Approved Opdivo + Yervoy as First-Line Treatment of Patients with Metastatic Non-Small Cell Lung Cancer on May 15, 2020
DBV Technologies S.A. -
Viaskin Peanut (BLA)
FDA decision on Viaskin Peanut for treatment of peanut allergy
08/05/2020
Ultragenyx Pharmaceutical Inc
UX007 (triheptanoin) (NDA)
FDA decision on for UX007 for treatment of Long-chain Fatty Acid Oxidation Disorders
07/31/2020
GW Pharmaceuticals PLC
GWPH, GWP.L
EPIDIOLEX (sNDA)
FDA decision on EPIDIOLEX to treat seizures associated with Tuberous Sclerosis Complex
07/31/2020
Jazz Pharmaceuticals plc
JZP-258 (NDA)
FDA decision on JZP-258 for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy.
07/21/2020
GlaxoSmithKline PLC
GSK.L, GSK
Belantamab mafodotin (BLA)
FDA decision on Belantamab mafodotin for the treatment of relapsed or refractory myeloma
07/21/2020
Seattle Genetics Inc.
Belantamab mafodotin (BLA)
FDA decision on Belantamab mafodotin for the treatment of relapsed or refractory myeloma
07/21/2020
Osmotica Pharmaceutical Corp
RVL-1201 (NDA)
FDA decision on RVL-1201 for Acquired Blepharoptosis (droopy eyelid or ptosis)
07/16/2020
Verrica Pharmaceuticals Inc.
VP-102 (cantharidin 0.7% Topical Solution) (NDA)
FDA decision on VP-102 for the Treatment of Molluscum Contagiosum
07/13/2020

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