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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
STARPHARMA HOLDINGS LTD.
SPHRY.OB
VivaGel (NDA)
FDA decision on VivaGel for bacterial vaginosis and prevention of recurrent bacterial vaginosis
Early Jan 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
FDA approved Sprycel on Jan 2
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
FDA Approves KEYTRUDA on Dec 19
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
FDA Approves Motegrity (Prucalopride) on Dec 17
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
FDA decision extended to March 20, 2019
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
FDA turns down its Prior Approval Supplement filing related to BIVIGAM; reported on Dec 19
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
Catalyst Pharmaceutical Partners Inc.
Firdapse (resubmitted NDA)
FDA decision on Firdapse for Lambert-Eaton myasthenic syndrome (LEMS)
11/28/2018
FDA approved Firdapse
Loxo Oncology, Inc.
Larotrectinib NDA
FDA decision on Larotrectinib for patients with locally advanced or metastatic solid tumors harboring NTRK gene fusion
11/26/2018
FDA approves Larotrectinib, under brand name Vitrakvi
Aquestive Therapeutics Inc.
AQST-119 (NDA)
FDA decision on AQST-119 for erectile dysfunction
11/18/2018
FDA rejects NDA for tadalafil oral film on Nov 16
Mallinckrodt plc
MNK-812(505(b)2 NDA)
FDA decision on MNK-812 for management of pain severe enough to require opioid analgesic
11/16/2018


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