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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
Alkermes plc
ALKS 5461 (NDA)
FDA’s final decision on ALKS 5461 for adjunctive treatment of major depressive disorder
01/31/2019
Aquestive Therapeutics Inc.
APL-130277 (NDA)
FDA decision on APL-130277 to overcome episodic off periods in Parkinson's disease
01/29/2019
Immunomedics Inc.
Sacituzumab govitecan (BLA)
FDA decision on Sacituzumab govitecan for treatment of metastatic triple-negative breast cancer
01/18/2019
Amgen Inc.
EVENITY (Resubmission BLA)
FDA panel to review EVENITY for osteoporosis in postmenopausal women at high risk for fracture
01/16/2019
Acorda Therapeutics Inc.
INBRIJA (NDA)
FDA decision on INBRIJA as a treatment for symptoms of OFF periods in people with Parkinson’s disease taking a carbidopa/levodopa regimen.
01/05/2019
Portola Pharmaceuticals Inc.
Andexxa Prior Approval Supplement
FDA decision on Andexxa for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed
12/31/2018
Bristol-Myers Squibb Co.
Sprycel (sBLA)
FDA decision on Sprycel in combination with chemotherapy for pediatric patients with Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia
12/29/2018
Merck & Co Inc.
Keytruda (sBLA)
FDA decision on proposed new indication for Keytruda for recurrent locally advanced or metastatic Merkel cell carcinoma
12/28/2018
Ocular Therapeutix Inc.
Dextenza (Resubmission NDA)
FDA decision on Dextenza for ocular pain following ophthalmic surgery
12/28/2018
Bristol-Myers Squibb Co.
Empliciti (sBLA)
FDA decision on Empliciti in combination with pomalidomide and low-dose dexamethasone (EPd) for the treatment of patients with relapsed/refractory multiple myeloma
12/27/2018
FDA approved Empliciti plus Pomalidomide and Dexamethasone for multiple myeloma on Nov.6, 2018
Roche Holding AG
Baloxavir Marboxil (NDA)
FDA decision on Baloxavir Marboxil for the treatment of acute, uncomplicated influenza in people 12 years and older
12/24/2018
Shire plc
SHPG, SHP.L
Prucalopride (NDA)
FDA decision on Prucalopride as a potential once-daily treatment option for chronic idiopathic constipation in adults
12/21/2018
Jazz Pharmaceuticals plc
Solriamfetol (NDA)
FDA decision on Solriamfetol for the treatment of excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea
12/20/2018
ADMA BIOLOGICS, INC.
BIVIGAM (Prior Approval Supplement)
FDA decision on BIVIGAM, an intravenous immune globulin indicated for the treatment of primary humoral immunodeficiency
12/18/2018
Roche Holding AG
TECENTRIQ (sBLA)
FDA decision on TECENTRIQ in combination with Avastin or bevacizumab, paclitaxel and carboplatin or chemotherapy for initial treatment of people with metastatic NSCLC
12/05/2018


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